A Study of Tarceva (Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer Naive to Chemotherapy

Sponsor
Hoffmann-La Roche
Study ID
NCT02013206
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This study will evaluate the efficacy and safety of Tarceva in two groups of patients with non-small cell lung cancer who have not been pre-treated with chemotherapy. One group, consisting of patients who have never smoked, will receive Tarceva 150 mg/day, and the other group, consisting of current/former smokers, will receive Tarceva 150 mg/day increasing to a maximum of 300 mg/day. The anticipated time on study treatment is 1-2 years.

Key Dates

First listed
Dec 17, 2013
Start date
Sep 30, 2006
Status verified
Dec 2014
Primary completion
Oct 31, 2010
Completion
Oct 31, 2010

Study Design

Enrollment
52 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Never Smokers
    Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib \[Tarceva\] 150 mg orally daily until disease progression or unacceptable toxicity.
  • Experimental: Current/Former Smokers
    Current Smokers (participants who smoked \> 100 cigarettes in entire lifetime and either quit smoking \< 1 year ago or were currently smoking) or Former Smokers (participants who smoked \> 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib \[Tarceva\] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.

Primary Outcome Measure

Non-Progression Rate (NPR) at 8 Weeks [ Time Frame: Week 8 ]

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