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Clinical Trial 20098
Cancer Type: Thoracic
Study Type: Treatment
NCT#: NCT03976323
Phase: Phase III
Prinicipal Investigator: Jhanelle Gray
Study Title
A Phase 3 Study of Pembrolizumab in Combination with Pemetrexed/Platinum (Carboplatin or Cisplatin) Followed by Pembrolizumab and Maintenance Olaparib vs Maintenance Pemetrexed in the First-Line Treatment of Participants with Metastatic Nonsquamous Non-Small-Cell Lung Cancer
Summary
The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, v.s. pembrolizumab plus maintenance pemetrexed for the treatment of nonsquamous NSCLC. The study's 2 primary hypotheses are: 1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) by blinded independent clinical review (BICR) and 2. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to overall survival (OS).
Objective
Primary Objectives: To compare pembrolizumab plus maintenance olaparib with pembrolizumab plus maintenance pemetrexed with respect to progression-free survival (PFS) assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by blinded independent central review (BICR). To compare pembrolizumab plus maintenance olaparib with pembrolizumab plus maintenance pemetrexed with respect to overall survival (OS). Secondary Objectives: To evaluate the safety and tolerability of pembrolizumab plus maintenance olaparib compared to pembrolizumab plus maintenance pemetrexed. To evaluate the change from baseline (at randomization) and the time to true deterioration (TTD) in global health status/quality of life (QoL), cough, chest pain, dyspnea and physical functioning following treatment with pembrolizumab plus maintenance olaparib compared with pembrolizumab plus pemetrexed. Exploratory Objectives: To evaluate pembrolizumab plus maintenance olaparib compared to pembrolizumab plus maintenance pemetrexed with respect to objective response rate (ORR) and duration of response (DOR) assessed according to RECIST 1.1 (Section 4.2.1.1) by BICR. To evaluate the effect of PD-L1 expression levels on the efficacy endpoints of OS and PFS assessed according to RECIST 1.1 (Section 4.2.1.1) by BICR. To evaluate pembrolizumab plus maintenance olaparib compared to pembrolizumab plus maintenance pemetrexed with respect to new anticancer therapy (PFS2), as assessed by the investigator using RECIST 1.1. To evaluate pembrolizumab plus maintenance olaparib compared to pembrolizumab plus pemetrexed with respect to the time to first subsequent anti-cancer therapy (TFST) and the time to second subsequent anti-cancer treatment (TSST). To characterize health utilities using the 5-level version of the European Quality of Life (EuroQoL) 5-dimension Questionnaire (EQ-5D-5L) to generate utility scores for use in economic models. To identify molecular (genomic, metabolic, and/or proteomic) biomarkers that may be indicative of clinical response/resistance, safety, pharmacodynamic activity, and/or the mechanism of action of pembrolizumab in combination with maintenance olaparib.
Therapies
Medications
Alimta (Pemetrexed); Olaparib (Lynparza); Paraplatin (carboplatin); Pembrolizumab (Keytruda); Pemetrexed (); carboplatin (); cisplatin ()
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