Trial Number

979-19

Condition

Lung Cancer

Participant Age Range

18 years to 120 years

Participant Gender

Any

Enrolling Participants

Yes

Overview

A Phase 3 Study of Pembrolizumab (MK-3475) in Combination with Concurrent Chemoradiation Therapy Followed by Pembrolizumab with or without Olaparib vs Concurrent Chemoradiation Therapy Followed by Durvalumab in Participants with Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer (NSCLC)

Worldwide, non-small cell lung cancer accounts for approximately 80% to 85% of all lung cancer cases, with 25% to one-third of patients presenting with Stage III at diagnosis. The first line standard of care for Stage III NSCLC, if good performance is present, consists of platinum-based doublet chemotherapy with concurrent radiotherapy. However, although the intent of concurrent chemoradiationtherapy is curative, relapses are common. Thus, there is a high unmet medical need in this population. Based on the critical need for new therapies in treatment of unresectable, locally advanced Stage III NSCLC and the growing scientific evidence for the potential synergism for the combination of pembrolizumab with concurrent chemoradiation therapy and olaparib in NSCLC, this Phase 3 study aims to determine whether pembrolizumab in combination with concurrent chemoradiation therapy followed by pembrolizumab with or without olaparib leads to improved Progression Free Survival (PFS) and Overall Survival (OS) when compared to concurrent chemoradiation therapy followed by durvalumab.

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