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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
200mg IV every 21 days
500mg/m\^2 IV every 21 days
AUC 5 IV every 21 days
The University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Median Duration of Time From Start of Treatment to Time of Progression
The primary endpoint is median progression free survival (PFS) which is defined as the median duration of time from the start of treatment to progression. Progression is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.
Time frame: Up to 5 years
Median Duration of Time From the Start of Treatment Until Death
The secondary endpoint is median overall survival (OS) which is defined as the median duration of time from the start of treatment until death.
Time frame: Up to 5 years
Response Rate
Percentage of patients who achieve a complete or partial response after at least one cycle of maintenance therapy with rucaparib and pembrolizumab. Response assessed by immune-related Response Evaluation Criteria in Solid Tumors (irRecist).
Time frame: Up to 5 years
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600mg PO, BID days 1-21 of each 21 day cycle