A Study of Tarceva (Erlotinib) or Placebo in Combination With Platinum-Based Therapy as First Line Treatment in Patients With Advanced or Recurrent Non-Small Cell Lung Cancer

Sponsor
Hoffmann-La Roche
Study ID
NCT00883779
Phase
PHASE3
Status
Completed

Conditions

  • Non-Squamous Non-Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    po on days 15-28 of each 4 week cycle until disease progression
  • Platinum chemotherapy (cisplatin or carboplatin) — DRUG
    cisplatin --75mg/m2 oon day 1 of each 4 week cycle for 6 cycles or carboplatin--5xAUC on day 1 of each 4 week cycle for 6 cycles
  • erlotinib [Tarceva] — DRUG
    150mg po on days 15-28 of each 4 week cycle until disease progression
  • gemcitabine — DRUG
    1250mg/m2 iv on days 1 and 8 of each 4 week cycle for 6 cycles

Study Details

This 2 arm study will compare the efficacy and safety of sequential treatment with Tarceva or placebo, plus platinum-based therapy, as first line treatment in patients with advanced or recurrent non-small cell lung cancer. Patients will be randomized to receive gemcitabine (1250mg/m2 iv) on days 1 and 8, and cisplatin (75mg/m2) or carboplatin (5xAUC)on day 1, followed by Tarceva 150mg/day or placebo from day 15 to day 28 of each 4 week cycle for a total of 6 cycles,then followed by Tarceva or placebo monotherapy.The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Key Dates

First listed
Apr 20, 2009
Start date
Apr 30, 2009
Status verified
Nov 2015
Primary completion
Dec 31, 2014
Completion
Dec 31, 2014

Study Design

Enrollment
451 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
  • Placebo Comparator: 2

Primary Outcome Measure

Median Progression Free Survival (PFS) Time [ Time Frame: Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years]) ]

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