Pembrolizumab: intravenous (IV) infusion
Olaparib: oral tablets
Placebo for olaparib: oral tablets
Etoposide: IV infusion
Carboplatin: IV infusion
Cisplatin: IV infusion
Paclitaxel: IV infusion
Pemetrexed: IV infusion
Thoracic Radiotherapy: external beam radiation
Durvalumab: IV infusion
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. The primary hypotheses are:
1. Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab with olaparib is superior to concurrent chemoradiation therapy followed by durvalumab with respect to progression-free survival (PFS) and overall survival (OS)
2. Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab is superior to concurrent chemoradiation therapy followed by durvalumab with respect to PFS and OS
| Facility | City | Region | Status |
|---|---|---|---|
| University of South Alabama, Mitchell Cancer Institute ( Site 0003) | Mobile | Alabama | |
| St. Bernards Medical Center ( Site 0089) | Jonesboro | Arkansas | |
| St Joseph Heritage Healthcare-Oncology ( Site 0088) | Fullerton | California | |
| Long Beach Memorial Medical Center ( Site 0006) | Long Beach | California | |
| UCLA Hematology/Oncology - Santa Monica ( Site 0013) | Los Angeles | California | |
| St. Joseph Heritage Healthcare Local Lab ( Site 0011) | Santa Rosa | California | |
| Torrance Memorial Physician Network / Cancer Center ( Site 0093) | Torrance | California | |
| Memorial Regional Hospital-Memorial Cancer Institute ( Site 0095) | Hollywood | Florida | |
| Miami VA Healthcare System ( Site 0024) | Miami | Florida | |
| Mid Florida Hematology and Oncology Center ( Site 0022) | Orange City | Florida | |
| Orlando Health, UF Health Cancer Center Inc ( Site 0092) | Orlando | Florida | |
| Fort Wayne Medical Oncology and Hematology ( Site 0094) | Fort Wayne | Indiana | |
| Parkview Research Center ( Site 0032) | Fort Wayne | Indiana | |
| Franciscan Health Lafayette East ( Site 0031) | Lafayette | Indiana | |
| University of Kentucky ( Site 0096) | Lexington | Kentucky | |
| Norton Brownsboro Hospital-Norton Cancer Institute - Brownsboro ( Site 0035) | Louisville | Kentucky | |
| Pikeville Medical Center ( Site 0036) | Pikeville | Kentucky | |
| Massachusetts General Hospital ( Site 0038) | Boston | Massachusetts | |
| Henry Ford Hospital ( Site 0045) | Detroit | Michigan | |
| VA St. Louis Health Care System ( Site 0047) | St Louis | Missouri | |
| Washington University Siteman Cancer Center ( Site 0046) | St Louis | Missouri | |
| CHI Health St. Francis ( Site 0053) | Grand Island | Nebraska | |
| Rutgers Cancer Institute of New Jersey ( Site 0054) | New Brunswick | New Jersey | |
| Valley Health Systems - Ridgewood Campus ( Site 0056) | Paramus | New Jersey | |
| Montefiore Einstein Center ( Site 0083) | The Bronx | New York | |
| Novant Health Presbyterian ( Site 0081) | Charlotte | North Carolina | |
| Duke University Medical Center ( Site 0050) | Durham | North Carolina | |
| Piedmont Hematology-Oncology Associates ( Site 0080) | Winston-Salem | North Carolina | |
| The Lindner Center for Research and Education at The Christ Hospital ( Site 0060) | Cincinnati | Ohio | |
| Fox Chase Cancer Center ( Site 0063) | Philadelphia | Pennsylvania | |
| Sanford Cancer Center Oncology Clinic ( Site 0066) | Sioux Falls | South Dakota | |
| Veterans Affairs Puget Sound Health Care System [Seattle, WA] ( Site 0075) | Seattle | Washington | |
| Cancer Care Northwest ( Site 0074) | Spokane Valley | Washington | |
| Clinica Adventista Belgrano-Oncology ( Site 4002) | Caba. | Buenos Aires | |
| Instituto Médico Río Cuarto ( Site 4003) | Río Cuarto | Córdoba Province | |
| Queen Elizabeth II Health Sciences Centre ( Site 0100) | Halifax | Nova Scotia | |
| Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0102) | Montreal | Quebec | |
| CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0108) | Montreal | Quebec | |
| McGill University Health Center - Research Institute ( Site 0114) | Montreal | Quebec | |
| Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0110) | Québec | Quebec |
+ 165 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04380636 on ClinicalTrials.gov ↗ ← All trials in the UK