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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00556712
Registration number
NCT00556712
Ethics application status
Date submitted
9/11/2007
Date registered
12/11/2007
Date last updated
11/02/2015
Titles & IDs
Public title
A Study of Tarceva (Erlotinib) Following Platinum-Based Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)
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Scientific title
A Randomized, Double-blind Study to Evaluate the Effect of Tarceva or Placebo Following Platinum-based CT on Overall Survival and Disease Progression in Patients With Advanced, Recurrent or Metastatic NSCLS Who Have Not Experienced Disease Progression or Unacceptable Toxicity During Chemotherapy
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Secondary ID [1]
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BO18192
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer
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Condition category
Condition code
Cancer
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0
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Lung - Mesothelioma
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Cancer
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0
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0
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Lung - Non small cell
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Cancer
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0
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - erlotinib [Tarceva]
Treatment: Drugs - Placebo
Experimental: Erlotinib - Participants received erlotinib, 150 milligrams (mg), orally (PO), daily from randomization until progressive disease (PD), death, or unacceptable toxicity.
Placebo Comparator: Placebo - Participants received a placebo, PO, daily, from randomization until PD, death, or unacceptable toxicity.
Treatment: Drugs: erlotinib [Tarceva]
150mg po daily
Treatment: Drugs: Placebo
po daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With PD According to Response Evaluation Criteria in Solid Tumors (RECIST) or Death (Data Cutoff 17 May 2008)
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Assessment method [1]
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Progression-free survival (PFS) was defined as the time from randomization to PD or death, whichever occurred first. For target lesions (TLs), PD was defined at least a 20 percent (%) increase in the sum of the largest diameter (SLD), taking as reference the smallest SLD recorded from baseline (BL) more the appearance of one or more new lesions. For non-target lesions (NTLs), PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented.
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Timepoint [1]
0
0
Screening, BL [=21 days after randomization], every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
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Primary outcome [2]
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PFS in All Participants (Data Cutoff 17 May 2008)
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Assessment method [2]
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The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% confidence interval (CI) was estimated using Kaplan-Meier methodology.
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Timepoint [2]
0
0
Screening, BL (=21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
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Primary outcome [3]
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Probable Percentage of Participants Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008)
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Assessment method [3]
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0
PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from BL more the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.
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Timepoint [3]
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6 months
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Primary outcome [4]
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Percentage of Epidermal Growth Factor Receptor (EGFR) Immunohistochemistry (IHC) Positive Participants With PD or Death (Data Cutoff 17 May 2008)
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Assessment method [4]
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0
PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented.
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Timepoint [4]
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Screening, BL (=21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
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Primary outcome [5]
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0
PFS in EGFR IHC Positive Population (Data Cutoff 17 May 2008)
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Assessment method [5]
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The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.
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Timepoint [5]
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0
Screening, BL (= 21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
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Primary outcome [6]
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Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive and Progression Free at 6 Months (Data Cutoff 17 May 2008)
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Assessment method [6]
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0
PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.
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Timepoint [6]
0
0
6 months
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Secondary outcome [1]
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Percentage of All Participants Who Died (Data Cutoff 12 January 2012)
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Assessment method [1]
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0
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Timepoint [1]
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Screening, BL (=21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months).
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Secondary outcome [2]
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Overall Survival (OS) in All Participants (Data Cutoff 12 January 2012)
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Assessment method [2]
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OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.
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Timepoint [2]
0
0
Screening, BL (= 21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months)
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Secondary outcome [3]
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Probable Percentage of Participants Remaining Alive at 1 Year (Data Cutoff 12 January 2012)
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Assessment method [3]
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OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.
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Timepoint [3]
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1 year
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Secondary outcome [4]
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0
Percentage of EGFR IHC Positive Participants Who Died (Data Cutoff 12 January 2012)
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Assessment method [4]
0
0
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Timepoint [4]
0
0
Screening, BL (=21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months)
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Secondary outcome [5]
0
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OS in EGFR IHC Positive Population (Data Cutoff 12 January 2012)
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Assessment method [5]
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0
OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.
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Timepoint [5]
0
0
Screening, BL (=21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months)
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Secondary outcome [6]
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0
Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive at 1 Year (Data Cutoff 12 January 2012)
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Assessment method [6]
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0
OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.
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Timepoint [6]
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0
1 year
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Secondary outcome [7]
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0
Percentage of EGFR IHC Negative Participants With PD or Death (Data Cutoff 17 May 2008)
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Assessment method [7]
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0
PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented.
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Timepoint [7]
0
0
Screening, BL (=21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 71 months)
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Secondary outcome [8]
0
0
PFS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008)
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Assessment method [8]
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0
The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.
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Timepoint [8]
0
0
Screening, BL (=21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
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Secondary outcome [9]
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0
Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008)
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Assessment method [9]
0
0
PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.
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Timepoint [9]
0
0
6 months
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Secondary outcome [10]
0
0
Percentage of EGFR IHC Negative Participants Who Died (Data Cutoff 17 May 2008)
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Assessment method [10]
0
0
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Timepoint [10]
0
0
Screening, BL (=21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
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Secondary outcome [11]
0
0
OS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008)
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Assessment method [11]
0
0
OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.
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Timepoint [11]
0
0
Screening, BL (=21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
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Secondary outcome [12]
0
0
Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive at 1 Year (Data Cutoff 17 May 2008)
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Assessment method [12]
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0
OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.
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Timepoint [12]
0
0
1 year
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Secondary outcome [13]
0
0
Time to Progression (Data Cutoff 17 May 2008)
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Assessment method [13]
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0
The median time, in weeks, between randomization and TTP event. Participants without PD were censored at the date of last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of PD, the participant was censored at the date of last tumor assessment before starting new chemotherapy.
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Timepoint [13]
0
0
Screening, BL (=21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
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Secondary outcome [14]
0
0
Probable Percentage of Participants Remaining Progression-Free in the TTP Analysis at 6 Months (Data Cutoff 17 May 2008)
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Assessment method [14]
0
0
TTP was defined as the time from the date of randomization to the first date PD was recorded. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD were censored at the date of last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of PD, the participant was censored at the date of last tumor assessment before starting new chemotherapy. The 95% CI was estimated using Kaplan-Meier methodology.
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Timepoint [14]
0
0
6 months
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Secondary outcome [15]
0
0
Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST (Data Cutoff 17 May 2008)
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Assessment method [15]
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0
BOR was defined as CR or PR confirmed by repeat assessments performed no less than 4 weeks after the criteria for response was first met. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.
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Timepoint [15]
0
0
Screening, BL (=21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
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Secondary outcome [16]
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0
Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST (Data Cutoff 17 May 2008)
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Assessment method [16]
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0
For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.
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Timepoint [16]
0
0
Screening, BL (=21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
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Secondary outcome [17]
0
0
Percentage of Participants With a Response Upgrade From BL According to RECIST (Data Cutoff 17 May 2008)
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Assessment method [17]
0
0
Response upgrade was defined by a change of PR to CR or of SD to PR or CR from BL to the end of treatment. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.
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Timepoint [17]
0
0
Screening, BL (=21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
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Secondary outcome [18]
0
0
Percentage of Participants With a Change of PR to CR or SD to PR or CR From BL to End of Treatment According to RECIST (Data Cutoff 17 May 2008)
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Assessment method [18]
0
0
For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.
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Timepoint [18]
0
0
Screening, BL (=21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
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Secondary outcome [19]
0
0
Percentage of Participants With CR, PR, or SD or With SD [Maintained For Greater Than (>) 12 Weeks] or CR or PR (Data Cutoff 17 May 2008)
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Assessment method [19]
0
0
Disease control was defined as a best response of CR or PR or SD or a best response of SD for more than 12 weeks, or CR or PR. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.
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Timepoint [19]
0
0
Screening, BL (=21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
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Secondary outcome [20]
0
0
Percentage of Participants With Symptom Progression Assessed Using the Lung Cancer Subscale (LCS) (Data Cutoff 17 May 2008)
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Assessment method [20]
0
0
LCS scores were obtained from a 7-item questionnaire from the Functional Assessment of Cancer Therapy - Lung (FACT-L) version (V) 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 equaled (=) "not at all" and 4 = "very much." The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline.
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Timepoint [20]
0
0
Screening, BL (=21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
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Secondary outcome [21]
0
0
Time to Symptom Progression (Data Cutoff 17 May 2008)
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Assessment method [21]
0
0
The median time, in weeks, from the date of randomization to the date of documented clinically meaningful decline in LCS from BL or death, whichever occurred first. LCS scores were obtained from a 7-item questionnaire from the FACT-L V 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 = "not at all" and 4 = "very much." The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline. The 95% CI was determined using Kaplan-Meier methodology.
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Timepoint [21]
0
0
Screening, BL (=21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
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Secondary outcome [22]
0
0
Probable Percentage of Participants Remaining Without Symptom Progression at 6 Months (Data Cutoff 17 May 2008)
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Assessment method [22]
0
0
LCS scores were obtained from a 7-item questionnaire from the FACT-L V 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 = "not at all" and 4 = "very much." The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline. The 95% CI was estimated using Kaplan-Meier methodology.
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Timepoint [22]
0
0
6 months
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Secondary outcome [23]
0
0
Percentage of Participants With Deterioration Assessed Using the Trial Outcome Index (Data Cutoff 17 May 2008)
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Assessment method [23]
0
0
The Trial Outcome Index (TOI) was defined as the sum of the scores of the Physical Well-Being (PWB), Functional Well-Being (FWB), and LCS. PWB, FWB, and LCS scores were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = "not at all" and 4 = "very much." Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment.
Query!
Timepoint [23]
0
0
Screening, BL (=21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
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Secondary outcome [24]
0
0
Time to Deterioration in TOI (Data Cutoff 17 May 2008)
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Assessment method [24]
0
0
The median time, in weeks, from the date of randomization until a clinically meaningful decline from BL in TOI or death, whichever occurred first. TOI was defined as the sum of PWB, FWB, and LCS scores, which were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = "not at all" and 4 = "very much." Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was determined using Kaplan-Meier methodology.
Query!
Timepoint [24]
0
0
Screening, BL (=21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
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Secondary outcome [25]
0
0
Probable Percentage of Participants Remaining Without Deterioration in TOI at 6 Months (Data Cutoff 17 May 2008)
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Assessment method [25]
0
0
TOI was defined as the sum of the scores of the PWB, FWB, and LCS. PWB, FWB, and LCS scores were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = "not at all" and 4 = "very much." Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was estimated using Kaplan-Meier methodology.
Query!
Timepoint [25]
0
0
6 months
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Secondary outcome [26]
0
0
Percentage of Participants With Deterioration in Quality of Life Assessed Using TOI, SWB, and EWB (Data Cutoff 17 May 2008)
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Assessment method [26]
0
0
Deterioration in quality of life (QoL) was defined as a clinically meaningful decline in the total FACT-L score, the sum of the TOI, Social/Family Well-Being (SWB) and Emotional Well-Being (EWB) of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = "not at all" and 4 = "very much." Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L.
Query!
Timepoint [26]
0
0
Screening, BL (=21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
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Secondary outcome [27]
0
0
Time to Deterioration in QoL (Data Cutoff 17 May 2008)
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Assessment method [27]
0
0
The median time, in weeks, from the date of randomization until a clinically meaningful decline from BL in total FACT-L or death, whichever occurred first. Total FACT-L score was defined as the sum of the TOI, SWB and EWB of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = "not at all" and 4 = "very much." Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was determined using Kaplan-Meier methodology.
Query!
Timepoint [27]
0
0
Screening, BL (=21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Query!
Secondary outcome [28]
0
0
Probable Percentage of Participants Remaining Without Deterioration in QoL at 6 Months (Data Cutoff 17 May 2008)
Query!
Assessment method [28]
0
0
Deterioration in QoL was defined as a clinically meaningful decline in the total FACT-L score, the sum of the TOI, SWB and EWB of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = "not at all" and 4 = "very much." Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L. The 95% CI was estimated using Kaplan-Meier methodology.
Query!
Timepoint [28]
0
0
6 months
Query!
Secondary outcome [29]
0
0
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008)
Query!
Assessment method [29]
0
0
Total FACT-L score=sum of TOI, SWB, and EWB of FACT-L questionnaires. TOI (PWB+FWB+LCS), SWB, and EWB scores obtained from 7-item (6-item for EWB) questionnaires from FACT-L V4. Participants responded to questions assessing symptoms (scale 0-4; 0="not at all" and 4="very much"). Higher score=more severe symptoms. The 7-item LCS assessed symptoms such as shortness of breath, loss of weight, tightness in chest. Participants responded to questions assessing symptoms (scale: 0-4; 0="not at all" and 4="very much"). Scores from 0-35; higher score=more severe symptoms. The 27 items of FACT-G were scored in the following domains: PWB (7 items, total score 0-28), SWB (7 items; total score 0-28), EWB (6 items, total score 0-24), and FWB (7 items; total score 0-28), higher scores=better QoL. Participants responded to items on 5-point Likert scale (0="Not at all" to 4="Very much"; total score: 0-108). Higher score=better QOL. TOI score=PWB+FWB+LCS; Total TOI score: 0-92; higher scores=better QOL.
Query!
Timepoint [29]
0
0
Screening, BL (=21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Query!
Secondary outcome [30]
0
0
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008)
Query!
Assessment method [30]
0
0
Total FACT-L score=sum of TOI, SWB, and EWB of FACT-L questionnaires. TOI (PWB+FWB+LCS), SWB, and EWB scores obtained from 7-item (6-item for EWB) questionnaires from FACT-L V4. Participants responded to questions assessing symptoms (scale 0-4; 0="not at all" and 4="very much"). Higher score=more severe symptoms. The 7-item LCS assessed symptoms such as shortness of breath, loss of weight, tightness in chest. Participants responded to questions assessing symptoms (scale: 0-4; 0="not at all" and 4="very much"). Scores from 0-35; higher score=more severe symptoms. The 27 items of FACT-G were scored in the following domains: PWB (7 items, total score 0-28), SWB (7 items; total score 0-28), EWB (6 items, total score 0-24), and FWB (7 items; total score 0-28), higher scores=better QoL. Participants responded to items on 5-point Likert scale (0="Not at all" to 4="Very much"; total score: 0-108). Higher score=better QOL. TOI score=PWB+FWB+LCS; Total TOI score: 0-92; higher scores=better QOL.
Query!
Timepoint [30]
0
0
Screening, BL (=21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Query!
Eligibility
Key inclusion criteria
- adult patients >=18 years of age;
- histologically documented, locally advanced , recurrent or metastatic NSCLC;
- measurable disease;
- no disease progression after 4 cycles of platinum-based chemotherapy.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- unstable systemic disease;
- any other malignancies in the last 5 years.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/01/2006
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/11/2010
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
889
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Query!
Recruitment hospital [1]
0
0
- St. Leonards
Query!
Recruitment hospital [2]
0
0
- Waratah
Query!
Recruitment hospital [3]
0
0
- Brisbane
Query!
Recruitment hospital [4]
0
0
- Adelaide
Query!
Recruitment hospital [5]
0
0
- East Bentleigh
Query!
Recruitment hospital [6]
0
0
- Fitzroy
Query!
Recruitment hospital [7]
0
0
- Geelong
Query!
Recruitment hospital [8]
0
0
- Melbourne
Query!
Recruitment postcode(s) [1]
0
0
2065 - St. Leonards
Query!
Recruitment postcode(s) [2]
0
0
2298 - Waratah
Query!
Recruitment postcode(s) [3]
0
0
4101 - Brisbane
Query!
Recruitment postcode(s) [4]
0
0
5041 - Adelaide
Query!
Recruitment postcode(s) [5]
0
0
VIC 3165 - East Bentleigh
Query!
Recruitment postcode(s) [6]
0
0
3065 - Fitzroy
Query!
Recruitment postcode(s) [7]
0
0
3220 - Geelong
Query!
Recruitment postcode(s) [8]
0
0
3084 - Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
Austria
Query!
State/province [1]
0
0
Innsbruck
Query!
Country [2]
0
0
Austria
Query!
State/province [2]
0
0
Klagenfurt
Query!
Country [3]
0
0
Austria
Query!
State/province [3]
0
0
Wien
Query!
Country [4]
0
0
Belgium
Query!
State/province [4]
0
0
Antwerpen
Query!
Country [5]
0
0
Belgium
Query!
State/province [5]
0
0
Edegem
Query!
Country [6]
0
0
Canada
Query!
State/province [6]
0
0
Manitoba
Query!
Country [7]
0
0
Canada
Query!
State/province [7]
0
0
Ontario
Query!
Country [8]
0
0
Canada
Query!
State/province [8]
0
0
Quebec
Query!
Country [9]
0
0
Chile
Query!
State/province [9]
0
0
Santiago
Query!
Country [10]
0
0
China
Query!
State/province [10]
0
0
Beijing
Query!
Country [11]
0
0
China
Query!
State/province [11]
0
0
Guangzhou
Query!
Country [12]
0
0
China
Query!
State/province [12]
0
0
Shanghai
Query!
Country [13]
0
0
Czech Republic
Query!
State/province [13]
0
0
Ceské Budejovice
Query!
Country [14]
0
0
Czech Republic
Query!
State/province [14]
0
0
Olomouc
Query!
Country [15]
0
0
Czech Republic
Query!
State/province [15]
0
0
Plzen
Query!
Country [16]
0
0
Denmark
Query!
State/province [16]
0
0
Herlev
Query!
Country [17]
0
0
Denmark
Query!
State/province [17]
0
0
Odense
Query!
Country [18]
0
0
France
Query!
State/province [18]
0
0
Bayonne
Query!
Country [19]
0
0
France
Query!
State/province [19]
0
0
Brest
Query!
Country [20]
0
0
France
Query!
State/province [20]
0
0
Clermont-ferrand
Query!
Country [21]
0
0
France
Query!
State/province [21]
0
0
Dijon
Query!
Country [22]
0
0
France
Query!
State/province [22]
0
0
Le Mans
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Lille
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Limoges
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Paris
Query!
Country [26]
0
0
France
Query!
State/province [26]
0
0
PAU
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
Toulouse
Query!
Country [28]
0
0
France
Query!
State/province [28]
0
0
Vandoeuvre-les-nancy
Query!
Country [29]
0
0
Germany
Query!
State/province [29]
0
0
Bad Berka
Query!
Country [30]
0
0
Germany
Query!
State/province [30]
0
0
Bochum
Query!
Country [31]
0
0
Germany
Query!
State/province [31]
0
0
Halle (Saale)
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
Herne
Query!
Country [33]
0
0
Germany
Query!
State/province [33]
0
0
Neuruppin
Query!
Country [34]
0
0
Germany
Query!
State/province [34]
0
0
Villingen-Schwenningen
Query!
Country [35]
0
0
Greece
Query!
State/province [35]
0
0
Athens
Query!
Country [36]
0
0
Greece
Query!
State/province [36]
0
0
Heraklion
Query!
Country [37]
0
0
Hungary
Query!
State/province [37]
0
0
Budapest
Query!
Country [38]
0
0
Hungary
Query!
State/province [38]
0
0
Deszk
Query!
Country [39]
0
0
Hungary
Query!
State/province [39]
0
0
Nyíregyháza
Query!
Country [40]
0
0
Hungary
Query!
State/province [40]
0
0
Pecs
Query!
Country [41]
0
0
Hungary
Query!
State/province [41]
0
0
Szombathely
Query!
Country [42]
0
0
Hungary
Query!
State/province [42]
0
0
Torokbalint
Query!
Country [43]
0
0
Italy
Query!
State/province [43]
0
0
Emilia-Romagna
Query!
Country [44]
0
0
Italy
Query!
State/province [44]
0
0
Lazio
Query!
Country [45]
0
0
Italy
Query!
State/province [45]
0
0
Marche
Query!
Country [46]
0
0
Korea, Republic of
Query!
State/province [46]
0
0
Daegu
Query!
Country [47]
0
0
Korea, Republic of
Query!
State/province [47]
0
0
Seoul
Query!
Country [48]
0
0
Korea, Republic of
Query!
State/province [48]
0
0
Suwon
Query!
Country [49]
0
0
Lithuania
Query!
State/province [49]
0
0
Kaunas
Query!
Country [50]
0
0
Lithuania
Query!
State/province [50]
0
0
Klaipeda
Query!
Country [51]
0
0
Lithuania
Query!
State/province [51]
0
0
Vilnius
Query!
Country [52]
0
0
Malaysia
Query!
State/province [52]
0
0
Kuala Lumpur
Query!
Country [53]
0
0
Malaysia
Query!
State/province [53]
0
0
Penang
Query!
Country [54]
0
0
Netherlands
Query!
State/province [54]
0
0
Amsterdam
Query!
Country [55]
0
0
Netherlands
Query!
State/province [55]
0
0
Heerlen
Query!
Country [56]
0
0
Netherlands
Query!
State/province [56]
0
0
Nieuwegein
Query!
Country [57]
0
0
Netherlands
Query!
State/province [57]
0
0
Vlissingen
Query!
Country [58]
0
0
New Zealand
Query!
State/province [58]
0
0
Auckland
Query!
Country [59]
0
0
New Zealand
Query!
State/province [59]
0
0
Christchurch
Query!
Country [60]
0
0
Poland
Query!
State/province [60]
0
0
Lodz
Query!
Country [61]
0
0
Poland
Query!
State/province [61]
0
0
Otwock
Query!
Country [62]
0
0
Romania
Query!
State/province [62]
0
0
Bucuresti
Query!
Country [63]
0
0
Romania
Query!
State/province [63]
0
0
Cluj Napoca
Query!
Country [64]
0
0
Romania
Query!
State/province [64]
0
0
Iasi
Query!
Country [65]
0
0
Romania
Query!
State/province [65]
0
0
Timisoara
Query!
Country [66]
0
0
Russian Federation
Query!
State/province [66]
0
0
Arkhangelsk
Query!
Country [67]
0
0
Russian Federation
Query!
State/province [67]
0
0
Balashikha
Query!
Country [68]
0
0
Russian Federation
Query!
State/province [68]
0
0
Chelyabinsk
Query!
Country [69]
0
0
Russian Federation
Query!
State/province [69]
0
0
Kazan
Query!
Country [70]
0
0
Russian Federation
Query!
State/province [70]
0
0
Kirov
Query!
Country [71]
0
0
Russian Federation
Query!
State/province [71]
0
0
Krasnodar
Query!
Country [72]
0
0
Russian Federation
Query!
State/province [72]
0
0
Kuzmolovo
Query!
Country [73]
0
0
Russian Federation
Query!
State/province [73]
0
0
Moscow
Query!
Country [74]
0
0
Russian Federation
Query!
State/province [74]
0
0
Nizhny Novgorod
Query!
Country [75]
0
0
Russian Federation
Query!
State/province [75]
0
0
Perm
Query!
Country [76]
0
0
Russian Federation
Query!
State/province [76]
0
0
Smolensk
Query!
Country [77]
0
0
Russian Federation
Query!
State/province [77]
0
0
Soshi
Query!
Country [78]
0
0
Russian Federation
Query!
State/province [78]
0
0
St Petersburg
Query!
Country [79]
0
0
Russian Federation
Query!
State/province [79]
0
0
Yaroslavl
Query!
Country [80]
0
0
Slovakia
Query!
State/province [80]
0
0
Banska Bystrica
Query!
Country [81]
0
0
Slovakia
Query!
State/province [81]
0
0
Bratislava
Query!
Country [82]
0
0
Slovakia
Query!
State/province [82]
0
0
Nitra
Query!
Country [83]
0
0
Slovakia
Query!
State/province [83]
0
0
Poprad
Query!
Country [84]
0
0
Slovenia
Query!
State/province [84]
0
0
Golnik
Query!
Country [85]
0
0
Slovenia
Query!
State/province [85]
0
0
Ljubljana
Query!
Country [86]
0
0
Slovenia
Query!
State/province [86]
0
0
Maribor
Query!
Country [87]
0
0
South Africa
Query!
State/province [87]
0
0
Durban
Query!
Country [88]
0
0
South Africa
Query!
State/province [88]
0
0
Johannesburg
Query!
Country [89]
0
0
South Africa
Query!
State/province [89]
0
0
Pretoria
Query!
Country [90]
0
0
Spain
Query!
State/province [90]
0
0
Asturias
Query!
Country [91]
0
0
Spain
Query!
State/province [91]
0
0
Cantabria
Query!
Country [92]
0
0
Spain
Query!
State/province [92]
0
0
La Coruña
Query!
Country [93]
0
0
Spain
Query!
State/province [93]
0
0
Valencia
Query!
Country [94]
0
0
Spain
Query!
State/province [94]
0
0
Zaragoza
Query!
Country [95]
0
0
Ukraine
Query!
State/province [95]
0
0
Kharkov
Query!
Country [96]
0
0
Ukraine
Query!
State/province [96]
0
0
Uzhgorod
Query!
Country [97]
0
0
Ukraine
Query!
State/province [97]
0
0
Zaporozhye
Query!
Country [98]
0
0
United Kingdom
Query!
State/province [98]
0
0
Chelmsford
Query!
Country [99]
0
0
United Kingdom
Query!
State/province [99]
0
0
Dundee
Query!
Country [100]
0
0
United Kingdom
Query!
State/province [100]
0
0
Leicester
Query!
Country [101]
0
0
United Kingdom
Query!
State/province [101]
0
0
Plymouth
Query!
Country [102]
0
0
Venezuela
Query!
State/province [102]
0
0
Caracas
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Hoffmann-La Roche
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva,
compared with placebo, following platinum-based chemotherapy in patients with advanced,
recurrent, or metastatic NSCLC who have not had disease progression or unacceptable toxicity
during chemotherapy. Following 4 cycles of platinum-based chemotherapy, eligible patients
will be randomized to receive either Tarceva 150mg po daily, or placebo daily. The
anticipated time on study treatment is until disease progression; the target sample size is
500+ individuals.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00556712
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Clinical Trials
Query!
Address
0
0
Hoffmann-La Roche
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00556712
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