A Study of First Line Treatment With Tarceva (Erlotinib) in Combination With Gemcitabine in Patients With Unresectable Advanced and/or Metastatic Non-Small Cell Lung Cancer

Sponsor
Hoffmann-La Roche
Study ID
NCT00701558
Phase
PHASE2
Status
Completed

Conditions

  • Non-small Cell Lung Cancer Metastatic

Eligibility Criteria

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

Interventions

  • Erlotinib — DRUG
    150 mg po daily
  • Gemcitabine — DRUG
    1000 mg/m\^2 iv on days 1, 8, 15 of each 4 week cycle for 6 cycles

Study Details

This single arm study will assess the efficacy and safety of erlotinib + gemcitabine in chemotherapy-naive participants with unresectable, advanced and/or metastatic non-small cell lung cancer. Participants will receive erlotinib 150 mg orally (po) daily, in combination with gemcitabine 1000 mg/m\^2 intravenously (iv) weekly for 3 weeks of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.

Key Dates

First listed
Jun 19, 2008
Start date
Aug 31, 2008
Status verified
May 2016
Primary completion
Oct 31, 2010
Completion
Dec 31, 2010

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Erlotinib + Gemcitabine
    Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m\^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.

Primary Outcome Measure

Time to Disease Progression [ Time Frame: From the time of randomization until disease progression or death (up to 193 weeks)] ]

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