A Study of Tarceva (Erlotinib) in Combination With Platinum Based Chemotherapy in Patients With Non-Small Cell Lung Cancer.
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).
1 other identifier
interventional
154
8 countries
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 nonsmall-cell-lung-cancer
Started Aug 2006
Longer than P75 for phase_2 nonsmall-cell-lung-cancer
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 25, 2013
CompletedFirst Posted
Study publicly available on registry
December 2, 2013
CompletedResults Posted
Study results publicly available
July 9, 2014
CompletedJanuary 13, 2015
December 1, 2014
5.3 years
November 25, 2013
April 7, 2014
December 12, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Week 8
Secondary Outcomes (6)
Percentage of Participants With Non-Progression at Week 16 as Assessed by RECIST
Week 16
Percentage of Participants With Confirmed CR or PR as Assessed by RECIST
Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases
Duration of Response
Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-study Phases
Time to Progression
Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases
Progression-Free Survival (PFS)
Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases
- +1 more secondary outcomes
Study Arms (2)
Tarceva + gemcitabine/platinum
EXPERIMENTALPlacebo + gemcitabine/platinum
PLACEBO COMPARATORInterventions
150 mg orally daily Days 15 to 28 of each 4-week cycle for 6 cycles, followed by 150 mg orally daily
orally daily Days 15 to 28 of each 4-week cycle for 6 cycles, followed by daily oral application
1250 mg/m2 iv Days 1 and 8 of each 4-week cycle, 6 cycles
75 mg/m2 iv Day 1 of each 4.wek cycle, 6 cycles; or carboplatin
5 x AUC iv Day 1 of each 4.week cycle, 6 cycles; or cisplatin
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- unstable systemic disease;
- any other malignancies in the last 5 years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Unknown Facility
Campbelltown, 2560, Australia
Unknown Facility
Camperdown, 2050, Australia
Unknown Facility
Liverpool, 2170, Australia
Unknown Facility
Guangzhou, 510060, China
Unknown Facility
Guangzhou, 510080, China
Unknown Facility
Shanghai, 200030, China
Unknown Facility
Shanghai, 200433, China
Unknown Facility
Hong Kong, Hong Kong
Unknown Facility
Jakarta, 10410, Indonesia
Unknown Facility
Jakarta, 10430, Indonesia
Unknown Facility
Semarang, 50136, Indonesia
Unknown Facility
Yogyakarta, 55284, Indonesia
Unknown Facility
Manila, 1000, Philippines
Unknown Facility
Metro Manila, 1502, Philippines
Unknown Facility
Kyunggi-do, 411-769, South Korea
Unknown Facility
Taipei, 100, Taiwan
Unknown Facility
Taipei, Taiwan
Unknown Facility
Bangkok, 10400, Thailand
Unknown Facility
Bangkok, 10700, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann- LaRoche
Study Officials
- STUDY CHAIR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2013
First Posted
December 2, 2013
Study Start
August 1, 2006
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
January 13, 2015
Results First Posted
July 9, 2014
Record last verified: 2014-12