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

Roche

Status and phase: Completed; Phase 4

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: Erlotinib; Drug: Chemotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT02000531

ML29028

Details and patient eligibility

About

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).

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• N/A

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Erlotinib-Chemotherapy

Experimental group

Description:

Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment

Treatment:

Drug: Chemotherapy

Drug: Erlotinib

Chemotherapy-Erlotinib

Active Comparator group

Description:

Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment

Treatment:

Drug: Chemotherapy

Drug: Erlotinib