A Study of Tarceva (Erlotinib) in Combination With Platinum Based Chemotherapy in Patients With Non-Small Cell Lung Cancer.

Sponsor
Hoffmann-La Roche
Study ID
NCT01998919
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • erlotinib [Tarceva] — DRUG
    150 mg orally daily Days 15 to 28 of each 4-week cycle for 6 cycles, followed by 150 mg orally daily
  • placebo — DRUG
    orally daily Days 15 to 28 of each 4-week cycle for 6 cycles, followed by daily oral application
  • gemcitabine — DRUG
    1250 mg/m2 iv Days 1 and 8 of each 4-week cycle, 6 cycles
  • cisplatin — DRUG
    75 mg/m2 iv Day 1 of each 4.wek cycle, 6 cycles; or carboplatin
  • carboplatin — DRUG
    5 x AUC iv Day 1 of each 4.week cycle, 6 cycles; or cisplatin

Study Details

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.

Key Dates

First listed
Dec 2, 2013
Start date
Aug 31, 2006
Status verified
Dec 2014
Primary completion
Nov 30, 2011
Completion
Nov 30, 2011

Study Design

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

Arms

  • Experimental: Tarceva + gemcitabine/platinum
  • Placebo Comparator: Placebo + gemcitabine/platinum

Primary Outcome Measure

Percentage of Participants With Non-Progression at Week 8 as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Week 8 ]

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