Conditions: Non Small Cell Lung Cancer
Keywords: GOAL Lung Non small cell lung cancer EGFR mutations
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 186
Healthy volunteers: no

Brief summary:
This is a study of gefitinib plus olaparib gefitinib in combination with olaparib (AZD2281) versus gefitinib alone, in patients with Epidermal Growth Factor Receptor (EGFR) mutation positive advanced non-small-cell lung cancer.

Detailed description:
GOAL is a multicenter, randomized phase IB/II study performed in two countries, Spain and Mexico. Eligible patients were 18 years or older, treatment-naïve, pathologically confirmed stage IV NSCLC, with centrally confirmed EGFR mutations and measurable disease. Patients were randomly allocated (1:1) to receive gefitinib 250 mg daily or gefitinib 250 mg daily plus olaparib 200 mg three times daily in 28-day cycles. The primary endpoint was PFS. Secondary endpoints included overall survival (OS), response rate, safety and tolerability.

Arms:
arm 1: Gefitinib will be administered once daily, continuously, in 28-day cycles, as a fixed dose of 250 mg/day. arm 2: Gefitinib 250 mg once a day, in combination with olaparib (at the recommended dose in the previous Phase I study) twice a day, continuously, in 28-day cycles.

Interventions: intervention 1: Gefitinib intervention 2: Olaparib
Intervention descriptions: intervention 1: Gefitinib 250 mg once a day, continuously, in 28-day cycles, until progression intervention 2: Gefitinib 250 mg once a day, in combination with olaparib (at the recommended dose in the previous Phase Ib study) twice a day, continuously, in 28-day cycles.

Protocol document: