Erlotinib 100mg qd Versus Gefitinib 250mg qd for EGFR Mutant Nsclc

Conditions

• Advanced Stage Non Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Erlotinib 100mg qd — DRUG
• Gefitinib 250mg qd — DRUG

Study Details

This study is a multicenter, randomized, open-label Phase II trial that compares reduced dose erlotinib 100mg daily and standard dose gefitinib 250mg daily in patients with advanced non-small cell lung cancer who harbor EGFR mutations. The primary endpoint is disease control rate (DCR) and the key secondary endpoint is progression free survival (PFS). A total of 224 eligible patients will be randomized to receive either erlotinib 100mg daily or gefitinib 250mg daily in a 1:1 ratio until patients experience disease progression. Independent assessment of the major endpoints will be completed in a treatment-blinded manner. Randomization will be stratified based on treatment-lines (first-line vs. maintenance vs. second-line therapy). Tumor response and progression will be assessed according to RECIST 1.1.

Key Dates

First listed

Oct 7, 2013

Start date

Jul 31, 2013

Status verified

Jul 2015

Primary completion

Jun 30, 2016

Study Design

Enrollment

224 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Erlotinib100
  Patients will be randomized to buy and receive erlotinib 100mg qd.
• Experimental: Gefitinib250
  Patients will be randomized to buy and receive gefitinib 250mg qd.

Primary Outcome Measure

disease control rate [ Time Frame: 2 years ]