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)
Objective
The purpose of this study is to assess the efficacy and safety of pembrolizumab in combination with concurrent chemoradiation therapy followed by either pembrolizumab with olaparib placebo (Arm 1) or with olaparib (Arm 2) compared to concurrent chemoradiation therapy followed by durvalumab (Arm 3) in participants with unresectable, locally advanced NSCLC. Arms 1 and 2 will be studied in a double-blind design and Arm 3 will be open-label.
Study Arms
- Experimental: pembrolizumab+chemoradiation→pembrolizumab+olaparib placebo
- Experimental: pembrolizumab+chemoradiation→pembrolizumab+olaparib
- Active Comparator: chemoradiation→durvalumab
Eligibility
- Has pathologically (histologically or cytologically) confirmed NSCLC
- Has Stage IIIA, IIIB, or IIIC NSCLC by American Joint Committee on Cancer Version 8
- Is unable to undergo surgery with curative intent for Stage III NSCLC
- Has no evidence of metastatic disease indicating Stage IV NSCLC
- Has measurable disease as defined by RECIST 1.1
- Has not received prior treatment (chemotherapy, targeted therapy or radiotherapy) for Stage III NSCLC
- Has provided a tumor tissue sample (tissue biopsy [core, incisional, or excisional])
- Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 assessed within 7 days prior to the first administration of study intervention
- Has a life expectancy of at least 6 months
- A male participant must agree to use contraception and refrain from donating sperm during the treatment period and for at least 180 days following the last dose of study treatment
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and agrees to use contraception and refrain from donating eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during the treatment period and for at least 180 days following the last dose of study treatment
- A female participant of child-bearing potential must have a negative highly sensitive pregnancy test (urine or serum) within 72 hours before the first dose of study treatment
- Has adequate pulmonary function tests
- Has adequate organ function
NCT ID
NCT04380636
