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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/NCT00520676
Registration number
NCT00520676
Ethics application status
Date submitted
22/08/2007
Date registered
24/08/2007
Date last updated
10/08/2011
Titles & IDs
Public title
Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer
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Scientific title
A Randomized Phase 3 Study Comparing Pemetrexed-Carboplatin With Docetaxel-Carboplatin as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
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Secondary ID [1]
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H3E-CR-S380
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Secondary ID [2]
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11626
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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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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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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 - pemetrexed
Treatment: Drugs - docetaxel
Treatment: Drugs - carboplatin
Experimental: pemetrexed plus carboplatin - Drug: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous (IV), every (q) 21 days x 6 cycles maximum
Drug: carboplatin Area Under the Curve (AUC) 5 milligram*minute/milliLiter (mg*min/mL), IV, q 21 days x 6 cycles maximum
Active Comparator: docetaxel plus carboplatin - Drug: docetaxel 75 mg/m^2, IV, q 21 days x 6 cycles maximum
Drug: carboplatin AUC 5 mg*min/mL, IV, q 21 days x 6 cycles maximum
Treatment: Drugs: pemetrexed
500 mg/m^2, IV, q 21 days x 6 cycles maximum
Treatment: Drugs: docetaxel
75 mg/m^2, IV, q 21 days x 6 cycles maximum
Treatment: Drugs: carboplatin
AUC 5 mg*min/mL, IV, q 21 days x 6 cycles maximum
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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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Survival Without Grade 3 or 4 Toxicity
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Assessment method [1]
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Defined as the time from date of randomization to first date of a Grade 3 or 4 treatment-emergent adverse event (TEAE; as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE], version 3.0) or death due to any cause. Grade 3 TEAE: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated. Grade 4 TEAE: Life-threatening consequences; urgent intervention indicated.
Participants who were alive without experiencing Grade 3 or 4 toxicity were censored at the date of last contact.
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Timepoint [1]
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Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS is the duration from enrollment to death. For participants who are alive, OS is censored at the last contact.
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Timepoint [1]
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Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).
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Secondary outcome [2]
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Progression-free Survival (PFS)
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Assessment method [2]
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Defined as the time from date of first dose to the first observation of disease progression (PD), or death due to any cause.
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Timepoint [2]
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Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).
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Secondary outcome [3]
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Percentage of Participants With Tumor Response (Response Rate)
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Assessment method [3]
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Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=at least a 20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes not meeting above criteria. Response rate (%)=Number of participants with CR+PR/Number of participants analyzed *100. Disease Control rate=Number of participants with SD+PR+CR/Number of participants analyzed *100.
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Timepoint [3]
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Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).
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Secondary outcome [4]
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Survival Without Clinically Important Grade 3 or 4 Toxicity
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Assessment method [4]
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Survival without Grade 3 or 4 toxicity is the time from date of randomization to the first date of the following clinically important Grade 3 or 4 TEAEs graded by the Common Terminology Criteria for Adverse Events [CTCAE], version 3.0: neutropenia (lasting >5 days), febrile neutropenia, documented infections related to neutropenia, anemia, thrombocytopenia, fatigue, nausea, vomiting, diarrhea, stomatitis, and neurosensory events; or death due to any cause. Participants who were alive without experiencing Grade 3 or 4 toxicity were censored for this analysis at the date of last contact.
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Timepoint [4]
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Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).
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Secondary outcome [5]
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Survival Without Grade 4 Toxicity
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Assessment method [5]
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Survival without Grade 4 toxicity is the time from the date of randomization to the first date of a Grade 4 TEAE or death due to any cause. Participants who are alive without experiencing Grade 4 toxicity will be censored for this analysis at the date of last contact.
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Timepoint [5]
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Baseline to until 218 events (defined as death or Grade 4 toxicity) have been observed (up to 33.3 months).
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Secondary outcome [6]
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Number of Participants With Adverse Events (AEs)
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Assessment method [6]
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Summaries of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module.
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Timepoint [6]
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Baseline to until 218 events (defined as death or Grade 3 or 4 toxicity) have been observed (up to 33.3 months).
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Eligibility
Key inclusion criteria
- Patient with locally advanced or metastatic (Stage IIIB/IV) NCSLC with no prior
chemotherapy for advanced disease or molecular target treatment
- Easter Cooperative Oncology Group (ECOG) performance status 0 to 2
- Estimated life expectancy of at least 8 weeks
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Known or suspected brain metastases
- Concurrent administration of any other tumor therapy
- Serious concomitant disorders
- Pregnancy or breast feeding
- Inability or unwillingness to take folic acid or vitamin B12 supplementation
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2010
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Sample size
Target
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Accrual to date
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Final
260
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Recruitment in Australia
Recruitment state(s)
VIC,WA
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Recruitment hospital [1]
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Ballarat
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Recruitment hospital [2]
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Frankston
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Recruitment hospital [3]
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Wendouree
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Recruitment hospital [4]
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Bunbury
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Recruitment postcode(s) [1]
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3350 - Ballarat
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Recruitment postcode(s) [2]
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3199 - Frankston
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Recruitment postcode(s) [3]
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3355 - Wendouree
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Recruitment postcode(s) [4]
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6230 - Bunbury
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Recruitment outside Australia
Country [1]
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Brazil
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State/province [1]
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Barretos
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Country [2]
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Brazil
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State/province [2]
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Goiania
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Country [3]
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Brazil
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State/province [3]
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Santo André
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Country [4]
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Brazil
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State/province [4]
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São Paulo
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Country [5]
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China
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State/province [5]
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Beijing
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Country [6]
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China
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State/province [6]
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Nanjing
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Country [7]
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China
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State/province [7]
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Shanghai
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Country [8]
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Korea, Republic of
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State/province [8]
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Seoul
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Country [9]
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Korea, Republic of
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State/province [9]
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Suwon-City
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Country [10]
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Korea, Republic of
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State/province [10]
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Ulsan
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Country [11]
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Mexico
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State/province [11]
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Ciudad Obregon
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Country [12]
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Mexico
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State/province [12]
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Durango
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Country [13]
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Mexico
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State/province [13]
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Mexicali
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Country [14]
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Mexico
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State/province [14]
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Mexico City
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Country [15]
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Taiwan
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State/province [15]
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Taichung
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Country [16]
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Taiwan
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State/province [16]
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Tao-Yuan
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eli Lilly and Company
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to compare the combination of pemetrexed and carboplatin with
the combination of docetaxel and carboplatin in terms of survival without Grade 3 or 4
toxicity in previously untreated patients with locally advanced or metastatic non-small cell
lung cancer (NSCLC).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00520676
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
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Address
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Eli Lilly and Company
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00520676
Download to PDF