A Study on the Correlation Between Tarceva (Erlotinib) - Induced Rash and Efficacy in EGFR Mutated Participants With Advanced Non-Small Cell Lung Cancer Receiving First-Line Therapy

Sponsor
Hoffmann-La Roche
Study ID
NCT01174563
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 [Tarceva] — DRUG
    150 mg orally daily, with dose-reductions to 100 mg or 50 mg orally daily according to protocol

Study Details

This open-label, single arm study will assess the correlation between Tarceva (erlotinib)-induced rash and efficacy in participants with inoperable, locally advanced, recurrent or metastatic non-small cell lung cancer (NSCLC) receiving first-line therapy for advanced disease. Participants will receive Tarceva at a dose of 150 mg daily orally, with dose adjustments according to protocol depending on toxicity. Anticipated time on study treatment is until disease progression, unacceptable toxicity, or withdrawal due to any reason.

Key Dates

First listed
Aug 3, 2010
Start date
May 23, 2011
Status verified
Sep 2018
Primary completion
Dec 20, 2016
Completion
Dec 20, 2016

Study Design

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

Arms

  • Experimental: Single Arm

Primary Outcome Measure

Progression-free Survival (PFS) According to Grade of Rash [ Time Frame: Day 1 of treatment period until disease progression or death (approximately up to 67 months) ]

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