Rucaparib and Pembrolizumab for Maintenance Therapy in Stage IV Non-Squamous Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT03559049|
Recruitment Status : Suspended (Enrollment temporarily paused for planned interim analysis; this is not a suspension of IRB approval)
First Posted : June 15, 2018
Last Update Posted : April 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stage IV Non-small Cell Lung Cancer||Drug: Pembrolizumab Drug: Pemetrexed Drug: Carboplatin Drug: Rucaparib||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||December 24, 2018|
|Estimated Primary Completion Date :||July 2024|
|Estimated Study Completion Date :||July 2027|
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).
200mg IV every 21 days
500mg/m^2 IV every 21 days
AUC 5 IV every 21 days
600mg PO, BID days 1-21 of each 21 day cycle
- Median duration of time from start of treatment to time of progression [ Time Frame: Up to 5 years ]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.
- Median duration of time from the start of treatment until death [ Time Frame: Up to 5 years ]The secondary endpoint is median overall survival (OS) which is defined as the median duration of time from the start of treatment until death.
- Response rate [ Time Frame: Up to 5 years ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03559049
|United States, Michigan|
|The University of Michigan Rogel Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|United States, Ohio|
|Ohio State University Comprehensive Cancer Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Nithya Ramnath, MBBS||University of Michigan Rogel Cancer Center|