A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Following 4 Cycles of Platinum-based Chemotherapy Without Disease Progression

Sponsor
Hoffmann-La Roche
Study ID
NCT01230710
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Erlotinib — DRUG
    Erlotinib was supplied as tablets.

Study Details

This open-label, single-arm study will evaluate the safety and efficacy of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer who have completed 4 cycles of standard platinum-based chemotherapy without progression. Patients will receive Tarceva at a dose of 150 mg orally daily until disease progression or unacceptable toxicity occurs.

Key Dates

First listed
Oct 29, 2010
Start date
Mar 31, 2011
Status verified
Mar 2015
Primary completion
Sep 30, 2013
Completion
Sep 30, 2013

Study Design

Enrollment
51 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Erlotinib
    Participants received erlotinib 150 mg orally once a day for 48 weeks.

Primary Outcome Measure

Percentage of Participants With Progression-free Survival at Week 52 [ Time Frame: From the date of enrolment in the study until the date of disease progression or death from any cause (up to 2 years, 6 months). ]

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