Progression Free Survival (PFS) Using Erlotinib for Non-Small-Cell Lung Cancer (NSCLC) in Chinese Population

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is an extension to ENSURE, a study of erlotinib versus gemcitabine/cisplatin combination chemotherapy as the first-line treatment for patients with non-small-cell lung cancer (NSCLC) with mutations in the tyrosine kinase domain of EGFR.

This study is designed to examine the efficacy of erlotinib versus gemcitabine/cisplatin as a second-line treatment in NSCLC patients from the ENSURE trial (NCT01342965). Patients previously treated with gemcitabine/cisplatin will be given erlotinib daily until disease progression or unacceptable toxicity occurs. Patients previously treated with erlotinib will be given cisplatin on Day 1 and gemcitabine on Days 1 and 8 of 3-week chemotherapy cycles until disease progression, unacceptable toxicity or up to 4 cycles (whichever comes first).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Cisplatin; Erlotinib Hydrochloride; Gemcitabine

Criteria

Inclusion Criteria:

• Participant in ENSURE trial

• Disease progression during first-line treatment

Exclusion Criteria:

• N/A