An Expanded Access Program of Tarceva (Erlotinib) in Participants With Advanced Non-Small Cell Lung Cancer (NSCLC)

Sponsor
Hoffmann-La Roche
Study ID
NCT00949910
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Erlotinib — DRUG
    Erlotinib will be given orally as 150 milligrams (mg) once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason.

Study Details

This study will provide treatment with erlotinib to participants with advanced NSCLC who have received at least one course of standard chemotherapy or radiation therapy, or who are not medically suitable for either. Efficacy and safety will be monitored throughout the study.

Key Dates

First listed
Jul 31, 2009
Start date
Nov 30, 2004
Status verified
Oct 2016
Primary completion
Apr 30, 2009
Completion
Apr 30, 2009

Study Design

Enrollment
6,586 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Erlotinib
    Erlotinib will be given as a single agent in this expanded access program (EAP) to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Treatment will continue until unacceptable toxicity, disease progression, or withdrawal for any other reason.

Primary Outcome Measure

Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter ]

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