Trial Details 105 Total Sites

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)

The purpose of this study is to compare overall survival (OS) and progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR). Hypothesis (H1): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR. Hypothesis (H2): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR. Hypothesis (H3): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to OS. Hypothesis (H4): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to OS.

phase

Phase 3

status

Recruiting

enrollment

672

score

55

start date

2020-12-08

last updated

2022-01-19

biomarkers

N/A

New York City, New York
facility
Memorial Sloan Kettering Cancer Center ( Site 0069)
1 facility
Recruiting
Houston, Texas
facility
MD Anderson Cancer Center ( Site 0100)
1 facility
Recruiting
Dallas, Texas
facility
Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 0093)
facility
Texas Oncology - Dallas (Presbyterian)_McIntyre ( Site 0098)
2 facilities
Recruiting
Baltimore, Maryland
facility
Harry & Jeanette Weinberg Cancer Institute ( Site 0045)
1 facility
Recruiting
Washington, Washington, D.C.
facility
Georgetown University ( Site 0017)
1 facility
Recruiting
Omaha, Nebraska
facility
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0061)
1 facility
Recruiting
Chandler, Arizona
facility
Ironwood Cancer & Research Centers ( Site 0007)
1 facility
Recruiting
Fort Wayne, Indiana
facility
Fort Wayne Medical Oncology and Hematology ( Site 0034)
1 facility
Recruiting
Tacoma, Washington
facility
Multicare Institute For Research And Innovation ( Site 0108)
1 facility
Recruiting
Shreveport, Louisiana
facility
Overton Brooks VAMC ( Site 0041)
1 facility
Recruiting
Knoxville, Tennessee
facility
The University of Tennessee Medical Center ( Site 0116)
1 facility
Recruiting
Ann Arbor, Michigan
facility
VA Ann Arbor Healthcare System ( Site 0050)
1 facility
Recruiting