Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013)
Condition(s) studied
Investigational drug(s) / intervention(s)
Pembrolizumab 200 mg: Pembrolizumab 200 mg Q3W
Pembrolizumab 400 mg: Pembrolizumab 400 mg Q6W
Pembrolizumab placebo (saline): Pembrolizumab placebo (saline) Q3W
Pembrolizumab placebo (saline): Pembrolizumab placebo (saline) Q6W
Olaparib 300 mg BID: Olaparib 300 mg twice daily (BID)
Olaparib matching placebo: Olaparib matching placebo BID
Etoposide 100 mg/m^2: Etoposide 100 mg/m\^2 intravenous (IV) Q3W, Day 1-3
Platinum, investigator's choice: Carboplatin titrated to an area under the plasma drug concentration time curve (AUC) of 5 mg/mL/min IV Q3W OR Cisplatin 75 mg/m\^2 IV Q3W on Day 1 of each cycle
Standard Thoracic Radiotherapy: Standard Thoracic Radiotherapy
Prophylactic Cranial Irradiation (PCI): PCI will be strongly recommended for participants who achieve CR or PR after completion of chemoradiation treatment.
Study summary
Researchers are looking for new ways to treat Limited-Stage Small Cell Lung Cancer (LS-SCLC), a type of lung cancer that has not spread from the lung to other parts of the body. The purpose of this study is to learn if pembrolizumab and olaparib, when given with chemotherapy and radiation treatment (CRT), can be effective in treating LS-SCLC. The researchers want to know if participants who receive CRT and pembrolizumab, with or without olaparib, have a longer overall survival compared to participants who only receive CRT.
Eligibility
Primary outcome measure(s)
- Overall Survival: the time from randomization to death due to any cause — Up to approximately 82 months
Overall Survival (OS) is the time from randomization to death due to any cause.
Trial sites (187)
| Facility | City | Region | Status |
|---|---|---|---|
| Ironwood Cancer & Research Centers ( Site 0007) | Chandler | Arizona | |
| Loma Linda University Cancer Center ( Site 0011) | Loma Linda | California | |
| Georgetown University ( Site 0017) | Washington D.C. | District of Columbia | |
| Moffitt Cancer Center ( Site 0137) | Tampa | Florida | |
| University of Chicago Medical Center ( Site 0136) | Chicago | Illinois | |
| Fort Wayne Medical Oncology and Hematology ( Site 0034) | Fort Wayne | Indiana | |
| University of Kentucky Chandler Medical Center ( Site 0138) | Lexington | Kentucky | |
| Overton Brooks VAMC ( Site 0041) | Shreveport | Louisiana | |
| Harry & Jeanette Weinberg Cancer Institute ( Site 0045) | Baltimore | Maryland | |
| VA Ann Arbor Healthcare System ( Site 0050) | Ann Arbor | Michigan | |
| St. Vincent Healthcare Frontier Cancer Center ( Site 0056) | Billings | Montana | |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0061) | Omaha | Nebraska | |
| Memorial Sloan Kettering - Basking Ridge ( Site 0133) | Basking Ridge | New Jersey | |
| John Theurer Cancer Center ( Site 0064) | Hackensack | New Jersey | |
| Memorial Sloan Kettering - Monmouth ( Site 0135) | Middletown | New Jersey | |
| Memorial Sloan Kettering - Bergen ( Site 0130) | Montvale | New Jersey | |
| Rutgers Cancer Institute of New Jersey ( Site 0123) | New Brunswick | New Jersey | |
| Memorial Sloan Kettering- Commack ( Site 0132) | Commack | New York | |
| Memorial Sloan Kettering - Westchester-Thoracic Oncology ( Site 0134) | Harrison | New York | |
| Memorial Sloan Kettering Cancer Center ( Site 0069) | New York | New York | |
| Memorial Sloan Kettering - Nassau ( Site 0131) | Uniondale | New York | |
| Fairview Hospital-Moll Cancer Center ( Site 0141) | Cleveland | Ohio | |
| Cleveland Clinic Main ( Site 0139) | Cleveland | Ohio | |
| Cleveland Clinic - Hillcrest Hospital-Hillcrest Hospital Cancer Center ( Site 0140) | Mayfield Heights | Ohio | |
| Penn State Hershey Cancer Institute ( Site 0081) | Hershey | Pennsylvania | |
| Saint Francis Cancer Center ( Site 0087) | Greenville | South Carolina | |
| The University of Tennessee Medical Center ( Site 0116) | Knoxville | Tennessee | |
| Texas Oncology - Dallas (Presbyterian)_McIntyre ( Site 0098) | Dallas | Texas | |
| Texas Oncology - Dallas (Sammons) ( Site 0093) | Dallas | Texas | |
| MD Anderson Cancer Center ( Site 0100) | Houston | Texas | |
| Millennium Research & Clinical Development ( Site 0143) | Houston | Texas | |
| Providence Regional Cancer Partnership ( Site 0106) | Everett | Washington | |
| Medical Oncology Associates, PS ( Site 0142) | Spokane | Washington | |
| Multicare Institute For Research And Innovation ( Site 0108) | Tacoma | Washington | |
| Virginia Mason Memorial- North Star Lodge Cancer Center ( Site 0112) | Yakima | Washington | |
| Campbelltown Hospital ( Site 3002) | Campbelltown | New South Wales | |
| Nepean Hospital ( Site 3001) | Kingswood | New South Wales | |
| Calvary Mater Newcastle ( Site 3000) | Waratah | New South Wales | |
| Gold Coast University Hospital ( Site 3003) | Southport | Queensland | |
| Frankston Hospital-Oncology and Haematology ( Site 3007) | Frankston | Victoria |
+ 147 more sites — see the full list on the official registry below.
More Merck Sharp & Dohme LLC trials in France
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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 NCT04624204 on ClinicalTrials.gov ↗ ← All trials in France