Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants With Advanced/Metastatic Non-small Cell Lung Cancer

Condition: Advanced/Metastatic Non-small Cell Lung Cancer

Sponsor: GSK

Phase III, Randomized, double blind, placebo-controlled, multicenter study comparing Niraparib plus Pembrolizumab versus placebo plus Pembrolizumab as maintenance therapy in participants whose diseases has remained stable or responded to first line platinum based chemotherapy with Pembrolizumab for stage IIIB/IIIC or IV NSCLC. This study will evaluate the efficacy of niraparib in combination with pembrolizumab in comparison to pembrolizumab plus placebo as maintenance therapy in participants with Stage IIIB/IIIC, or IV NSCLC (both squamous and non-squamous histology) who have achieved SD, PR, or CR in response to standard of care induction with 4 to 6 cycles of platinum-based chemotherapy and pembrolizumab. Patients with asymptomatic brain metastases (BM) will be allowed to enroll in this study given the high potential of lung cancer patients to have or develop BM during treatment.


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