drugset / Trial / NCT03009682

Olaparib Monotherapy in Relapsed Small Cell Lung Cancer Patients With HR Pathway Gene Mutations Not Limited to BRCA 1/2 Mutations, ATM Deficiency or MRE11A Mutations

NCT03009682 ↗

Phase 2 Completed 15 enrolled Samsung Medical Center
NaSingle-groupOpen-labelTreatment

Summary

This study is a single arm, multi-center phase II study of olaparib monotherapy in patients with relapsed small cell lung cancer (SCLC) harboring HR pathway gene mutations not limited to BRCA 1/2 mutations, ATM deficiency or MRE11A mutations as second or third line chemotherapy. Target subject population: Patients with small cell lung cancer that have progressed following first-line platinum-based therapy. Patients must have imaging confirmed progression on 1st line chemotherapy for SCLC treatment, which must have contained platinum-based regimen, with at least one measurable lesion per RECIST 1.1.

Timeline

Start
2016-08
Primary completion
2021-01
Completion
2021-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Olaparib Small molecule 300 mg Oral