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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00760929
Registration number
NCT00760929
Ethics application status
Date submitted
25/09/2008
Date registered
26/09/2008
Titles & IDs
Public title
A Study of the Effect of R1507 in Combination With Tarceva (Erlotinib) on Progression-Free Survival in Patients With Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC).
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Scientific title
A Randomized, Placebo Controlled Study to Determine the Effect of Two Dose Schedules of R1507 or Placebo, Both in Combination With Erlotinib (Tarceva®), on Progression-free Survival in Patients With Advanced Non-small Cell Lung Cancer With Disease Progression After First or Second Line Chemotherapy
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Secondary ID [1]
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2008-001736-12
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Secondary ID [2]
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NO21160
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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-Squamous 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 - Placebo
Treatment: Drugs - Placebo
Treatment: Drugs - RG1507
Treatment: Drugs - RG1507
Treatment: Drugs - erlotinib [Tarceva]
Placebo comparator: Placebo for R1507 (16mg/kg iv) -
Placebo comparator: Placebo for R1507 (9mg/kg iv) -
Experimental: R1507 (16mg/kg iv) -
Experimental: R1507 (9mg/kg iv) -
Treatment: Drugs: Placebo
iv 9mg/kg weekly
Treatment: Drugs: Placebo
iv 16mg/kg every 3 weeks
Treatment: Drugs: RG1507
iv 9mg/kg weekly
Treatment: Drugs: RG1507
iv 16mg/kg every 3 weeks
Treatment: Drugs: erlotinib [Tarceva]
150mg oral 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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Number of Participants With Progression Free Survival (PFS)
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Assessment method [1]
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PFS was defined as the time at which half of the participants have progressed (progressive disease \[PD\]) based on RECIST tumor response criteria or died from any cause, whichever occurred first. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Participants who had not died or progressed at the time of the final analysis were censored at the date of last contact.
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Timepoint [1]
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12 weeks
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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 was defined as the median time, in weeks, from the date of randomization to the date of death, due to any cause. Participants who have not died at the time of the final analysis will be censored at the date the participant was last known to be alive. The 90% CI was estimated using Kaplan-Meier methodology.
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Timepoint [1]
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From baseline up to 20 months
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Secondary outcome [2]
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Objective Response Rate
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Assessment method [2]
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Objective response rate (ORR) was defined by RECIST criteria as the best response achieved by a patient over the course of the trial, which includes a complete response (CR) or partial response (PR) that has been confirmed by a second tumor assessment no earlier than 4 weeks after the initial documentation, stable disease (SD), or progressive disease (PD). PR was defined as = 30% decrease in sum of longest diameter of all target lesions, from baseline sum. CR was defined as disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. PD = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions. SD = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on the study.
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Timepoint [2]
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From baseline up to 20 months
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Secondary outcome [3]
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Duration of Response
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Assessment method [3]
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Duration of response was defined as the time from the first documented complete response (CR) or partial response (PR) to the first documented disease progression (PD) or death, whichever occurs first. A CR was defined as the disappearance of all target lesions (TL). A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs taking as reference the Baseline SLD. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs.
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Timepoint [3]
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From baseline up to 20 months
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Secondary outcome [4]
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Time to Response
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Assessment method [4]
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This is defined for participants with objective response, as the date of randomization to the date of first CR or PR which will be the date the response is first radiographically documented following initiation of therapy (the date of the actual imaging modality).
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Timepoint [4]
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From baseline up to 20 months
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Eligibility
Key inclusion criteria
* male or female patients >=18 years with histologically documented inoperable, locally advanced or metastatic (stage IIIB or IV) NSCLC;
* patients must have failed at least one but no more than two standard chemotherapy regimens;
* measurable disease according to the RECIST criteria;
* Eastern Cooperative Oncology Group (ECOG) performance status;
* life expectancy >12 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
* patients with active central nervous system (CNS) lesions;
* prior treatment with agents acting via insulin-like growth factor 1 receptor (IGF-1R) inhibition or epidermal growth factor receptor (EGFR) targeting;
* administration with high doses of systemic corticosteroids;
* radiotherapy in the 4 weeks prior to study start;
* surgery or significant traumatic injury with in the last 2 weeks prior to study start.
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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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
10/11/2008
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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
25/06/2010
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Sample size
Target
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Accrual to date
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Final
171
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Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
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Recruitment hospital [1]
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Flinders Medical Center; Medical Oncology - Adelaide
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Recruitment hospital [2]
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Frankston Hospital; Oncology/Haematology - Frankston
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Recruitment hospital [3]
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment postcode(s) [1]
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5041 - Adelaide
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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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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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California
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Florida
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Bruxelles
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Charleroi
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Lyon
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Germany
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Heidelberg
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Germany
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Herne
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Germany
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Madrid
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Vizcaya
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Malaga
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Newcastle Upon Tyne
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United Kingdom
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Hoffmann-La Roche
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Address
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Ethics approval
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Summary
Brief summary
This 4 arm study in patients with advanced Stage IIIb/IV non-small cell cancer (NSCLC) who failed at least one standard chemotherapy regimen will determine the proportion of patients with progression-free survival at 12 weeks following combination therapy with R1507 and Tarceva or placebo and Tarceva. Patients will be randomized to one of four treatment arms to receive R1507 (9mg/kg iv) or placebo weekly or R1507 (16mg/kg iv) or placebo every 3 weeks. Tarceva (150mg oral daily) will be administered in all treatment arms. Other disease-related endpoints including overall survival, objective response rate, time to response, time to progressive disease and duration of response will also be evaluated. The anticipated time on study treatment is 1-2 years, and the target sample size is \<500 individuals.
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Trial website
https://clinicaltrials.gov/study/NCT00760929
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Trial related presentations / publications
Ramalingam SS, Spigel DR, Chen D, Steins MB, Engelman JA, Schneider CP, Novello S, Eberhardt WE, Crino L, Habben K, Liu L, Janne PA, Brownstein CM, Reck M. Randomized phase II study of erlotinib in combination with placebo or R1507, a monoclonal antibody to insulin-like growth factor-1 receptor, for advanced-stage non-small-cell lung cancer. J Clin Oncol. 2011 Dec 1;29(34):4574-80. doi: 10.1200/JCO.2011.36.6799. Epub 2011 Oct 24.
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Public notes
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Contacts
Principal investigator
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Address
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Hoffmann-La Roche
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00760929