NCT03559049

Rucaparib and Pembrolizumab for Maintenance Therapy in Stage IV Non-Squamous Non-Small Cell Lung Cancer

A Phase I/II Multi-site Study of Rucaparib and Pembrolizumab Maintenance Therapy in Stage IV Non-Squamous Non-Small Cell Lung Cancer After Initial Therapy With Carboplatin, Pemetrexed, and Pembrolizumab

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a multi-center, Phase I/II, single arm trial to assess the safety and efficacy of the combination of oral rucaparib plus intravenous pembrolizumab as maintenance therapy in patients with stage IV non-squamous non-small cell lung cancer (NSCLC) without progressive disease (PD), as confirmed on CT scans, after induction therapy with carboplatin/pemetrexed/pembrolizumab (CPP) triplet therapy.

Conditions

• Stage IV Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	200mg IV every 21 days
DRUG	Pemetrexed	500mg/m\^2 IV every 21 days
DRUG	Carboplatin	AUC 5 IV every 21 days
DRUG	Rucaparib	600mg PO, BID days 1-21 of each 21 day cycle

Timeline

• Start date: 2018-12-24
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2018-06-15
• Last updated: 2026-02-12
• Results posted: 2026-02-12

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study