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

Phase 4

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: Erlotinib; Drug: Chemotherapy

• Registration Number: NCT02000531
• Lead Sponsor: Hoffmann-La Roche

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-27
• Study First Submitted QC: 2013-11-27
• Study First Posted: 2013-12-04
• Study Start: 2014-01
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-12
• Results First Submitted: 2015-12-09
• Results First Submitted QC: 2015-12-09
• Last Update Submitted: 2015-12-09
• Results First Posted: 2016-01-13
• Last Update Posted: 2016-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Participant in ENSURE trial
• Disease progression during first-line treatment

Exclusion Criteria

• N/A

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemotherapy-Erlotinib	Chemotherapy	Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
Erlotinib-Chemotherapy	Chemotherapy	Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment
Erlotinib-Chemotherapy	Erlotinib	Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment
Chemotherapy-Erlotinib	Erlotinib	Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS) Based on Well-documented and Verifiable Progression Events	within 3 years, 9 months (data cut-off December 2014)	Progression free survival is defined as the time of randomization in ENSURE study to progressive disease (PD) while on second-line treatment or death from any cause, whichever occurred first during the second-line treatment.

Secondary Outcome Measures

Name	Time	Method
Participants With Adverse Events	start of second-line treatment to data cut-off in December 2014 (within 12 months)