A Study of Tarceva (Erlotinib) as First Line Therapy in Participants With Non-Small Cell Lung Cancer Harbouring Epidermal Growth Factor Receptor (EGFR) Mutations

Sponsor
Hoffmann-La Roche
Study ID
NCT01310036
Phase
PHASE2
Status
Completed

Conditions

  • Non-Squamous Non-Small Cell Lung Cancer

Eligibility Criteria

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

Interventions

  • Erlotinib — DRUG
    Erlotinib 150 mg was administered orally daily until disease progression or unacceptable toxicity.

Study Details

This open-label, single arm study will evaluate the safety and efficacy of Tarceva (erlotinib) as first-line therapy in participants with stage IV or recurrent non-small cell lung cancer who harbour epidermal growth factor receptor (EGFR) mutations. All participants will receive Tarceva 150 mg daily orally until disease progression or unacceptable toxicity occurs. At the investigator's discretion, participants may receive Tarceva beyond disease progression.

Key Dates

First listed
Mar 7, 2011
Start date
Apr 30, 2011
Status verified
Sep 2018
Primary completion
Feb 14, 2014
Completion
Dec 30, 2016

Study Design

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

Arms

  • Experimental: Erlotinib
    Erlotinib 150 mg daily

Primary Outcome Measure

Progression-free Survival Per RECIST, v. 1.1 (PFS1) [ Time Frame: Approximately 68 months ]

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