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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT03559049
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Stage IV Non-small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 24, 2018
Status verified
Feb 2026
Primary completion
May 1, 2025
Completion
May 1, 2025

Study Design

Enrollment
25 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rucaparib and Pembrolizumab Maintenance
    All patients will receive induction therapy with Pembrolizumab (200mg IV on day 1 of every 21 days), Pemetrexed (500mg/m\^2 IV on day 1 of every 21 days), and Carboplatin (AUC5 IV on day 1 of every 21 days). This will be followed by maintenance therapy with Pembrolizumab (200mg IV on day 1 of every 21 days) and Rucaparib (600mg PO BID days 1-21 of each 21 day cycle).

Primary Outcome Measure

Median Duration of Time From Start of Treatment to Time of Progression [ Time Frame: Up to 5 years ]

Locations (3)

FacilityCityStateZIPSite coordinators
The University of Michigan Rogel Cancer CenterAnn ArborMichigan48109-
Washington University School of MedicineSt LouisMissouri63110-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-

Related coverage on Hipa.ai

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The University of Michigan Rogel Cancer Center· Ann Arbor, MIWashington University School of Medicine· St Louis, MOOhio State University Comprehensive Cancer Center· Columbus, OH

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