Back to resultsA Study of Tarceva (Erlotinib) in Combination With Platinum Based Chemotherapy in Patients With Non-Small Cell Lung Cancer.
Primary Purpose
Non-Small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
erlotinib [Tarceva]
placebo
gemcitabine
cisplatin
carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- adult patients, >=18 years of age;
- histologically documented advanced or recurrent stage IIIB or IV non-small cell lung cancer;
- measurable disease;
- no previous chemotherapy for non-small cell lung cancer.
Exclusion Criteria:
- unstable systemic disease;
- any other malignancies in the last 5 years.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tarceva + gemcitabine/platinum
Placebo + gemcitabine/platinum
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Participants With Non-Progression at Week 8 as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
Non-progression defined as documented best overall tumor response of complete response (CR), partial response (PR), or stable disease (SD; where SD was maintained for greater than [>]8 weeks) per RECIST. Investigator's assessment of response used in all analyses. CR equals (=)disappearance of all target lesions; PR=at least a 30 percent (%) decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD; SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference smallest sum LD since treatment started.
Secondary Outcome Measures
Percentage of Participants With Non-Progression at Week 16 as Assessed by RECIST
Non-progression defined as documented best overall tumor response of CR, PR, or SD (where SD was maintained for >16 weeks) per RECIST.
Percentage of Participants With Confirmed CR or PR as Assessed by RECIST
CR=disappearance of all target lesions; PR=at least a 30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD.
Duration of Response
Duration of Response was defined similarly for complete responders and partial responders. CR was defined as the date CR was first recorded to the date on which PD was first noted or date of death. PR was defined as the date the first PR was recorded to the date of the first observation of PD or date of death.
Time to Progression
Time to progression was defined as the interval between the day of randomization and the first documentation of PD. Participants who were withdrawn from the study without documented progression and for whom there exists CRF evidence that evaluations have been made, were censored at 1) the date of the last tumor assessment, 2) last date in the drug log, or 3) last date of follow-up when the participant was known to be progression free, whichever was last. Participants without post-baseline tumor assessments but known to be alive were censored at the time of randomization.
Progression-Free Survival (PFS)
PFS was defined as the interval between the day of randomization and the date of first documentation of progressive disease or date of death, whichever came first.
Overall Survival
Overall Survival (OS) was defined as the time from the date of randomization to the date of death, regardless of the cause of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01998919
Brief Title
A Study of Tarceva (Erlotinib) in Combination With Platinum Based Chemotherapy in Patients With Non-Small Cell Lung Cancer.
Official Title
A Randomised, Placebo-controlled, Double-blind Phase II of Sequential Administration of Tarceva (Erlotinib) or Placebo in Combination With Gemcitabine/Platinum as First-line Treatment in Patients With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC).
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This study will evaluate the efficacy and safety of sequential administration of Tarceva and gemcitabine/platinum chemotherapy in patients with stage IIIb/IV non-small cell lung cancer. Patients will be randomized to receive Tarceva (150 mg po) or placebo on days 15-28 of a 4 week cycle of intravenous platinum-based chemotherapy, for a total of 6 cycles. The anticipated time on study treatment is until disease progression or unacceptable toxicity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
154 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tarceva + gemcitabine/platinum
Arm Type
Experimental
Arm Title
Placebo + gemcitabine/platinum
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
erlotinib [Tarceva]
Intervention Description
150 mg orally daily Days 15 to 28 of each 4-week cycle for 6 cycles, followed by 150 mg orally daily
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
orally daily Days 15 to 28 of each 4-week cycle for 6 cycles, followed by daily oral application
Intervention Type
Drug
Intervention Name(s)
gemcitabine
Intervention Description
1250 mg/m2 iv Days 1 and 8 of each 4-week cycle, 6 cycles
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
75 mg/m2 iv Day 1 of each 4.wek cycle, 6 cycles; or carboplatin
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Description
5 x AUC iv Day 1 of each 4.week cycle, 6 cycles; or cisplatin
Primary Outcome Measure Information:
Title
Percentage of Participants With Non-Progression at Week 8 as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
Description
Non-progression defined as documented best overall tumor response of complete response (CR), partial response (PR), or stable disease (SD; where SD was maintained for greater than [>]8 weeks) per RECIST. Investigator's assessment of response used in all analyses. CR equals (=)disappearance of all target lesions; PR=at least a 30 percent (%) decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD; SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference smallest sum LD since treatment started.
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Percentage of Participants With Non-Progression at Week 16 as Assessed by RECIST
Description
Non-progression defined as documented best overall tumor response of CR, PR, or SD (where SD was maintained for >16 weeks) per RECIST.
Time Frame
Week 16
Title
Percentage of Participants With Confirmed CR or PR as Assessed by RECIST
Description
CR=disappearance of all target lesions; PR=at least a 30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD.
Time Frame
Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases
Title
Duration of Response
Description
Duration of Response was defined similarly for complete responders and partial responders. CR was defined as the date CR was first recorded to the date on which PD was first noted or date of death. PR was defined as the date the first PR was recorded to the date of the first observation of PD or date of death.
Time Frame
Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-study Phases
Title
Time to Progression
Description
Time to progression was defined as the interval between the day of randomization and the first documentation of PD. Participants who were withdrawn from the study without documented progression and for whom there exists CRF evidence that evaluations have been made, were censored at 1) the date of the last tumor assessment, 2) last date in the drug log, or 3) last date of follow-up when the participant was known to be progression free, whichever was last. Participants without post-baseline tumor assessments but known to be alive were censored at the time of randomization.
Time Frame
Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases
Title
Progression-Free Survival (PFS)
Description
PFS was defined as the interval between the day of randomization and the date of first documentation of progressive disease or date of death, whichever came first.
Time Frame
Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases
Title
Overall Survival
Description
Overall Survival (OS) was defined as the time from the date of randomization to the date of death, regardless of the cause of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment.
Time Frame
Date of randomization until date of death or date of last follow-up assessment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients, >=18 years of age;
histologically documented advanced or recurrent stage IIIB or IV non-small cell lung cancer;
measurable disease;
no previous chemotherapy for non-small cell lung cancer.
Exclusion Criteria:
unstable systemic disease;
any other malignancies in the last 5 years.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
City
Campbelltown
ZIP/Postal Code
2560
Country
Australia
City
Camperdown
ZIP/Postal Code
2050
Country
Australia
City
Liverpool
ZIP/Postal Code
2170
Country
Australia
City
Guangzhou
ZIP/Postal Code
510060
Country
China
City
Guangzhou
ZIP/Postal Code
510080
Country
China
City
Shanghai
ZIP/Postal Code
200030
Country
China
City
Shanghai
ZIP/Postal Code
200433
Country
China
City
Hong Kong
Country
Hong Kong
City
Jakarta
ZIP/Postal Code
10410
Country
Indonesia
City
Jakarta
ZIP/Postal Code
10430
Country
Indonesia
City
Jogjakarta
ZIP/Postal Code
55284
Country
Indonesia
City
Semarang
ZIP/Postal Code
50136
Country
Indonesia
City
Kyunggi-do
ZIP/Postal Code
411-769
Country
Korea, Republic of
City
Manila
ZIP/Postal Code
1000
Country
Philippines
City
Metro Manila
ZIP/Postal Code
1502
Country
Philippines
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
City
Taipei
Country
Taiwan
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
A Study of Tarceva (Erlotinib) in Combination With Platinum Based Chemotherapy in Patients With Non-Small Cell Lung Cancer.
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