TY - JOUR
T1 - Rationale and Design of the Phase 3 KEYLYNK-013 Study of Pembrolizumab With Concurrent Chemoradiotherapy Followed by Pembrolizumab With or Without Olaparib for Limited-Stage Small-Cell Lung Cancer
AU - Rimner, Andreas
AU - Lai, Wei-Chu Victoria
AU - Califano, Raffaele
AU - Jabbour, Salma K
AU - Rudin, Charles M
AU - Faivre-Finn, Corinne
AU - Cho, Byoung Chul
AU - Kato, Terufumi
AU - Yu, Jinming
AU - Chafin, Wyatt
AU - Yu, Li
AU - Zhao, Bin
AU - Byers, Lauren
N1 - Funding Information:
We thank the participants and their families and caregivers, all primary investigators and their site personnel; Cathy Pietanza for study support (Merck & Co., Inc., Rahway, NJ, USA); and Ina Nikolaeva (Merck & Co., Inc., Rahway, NJ, USA) for medical writing assistance. This study and assistance with manuscript editing were funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ, USA. Dr. Rimner was funded in part through the NIH/NCI Cancer Center Support Grant P30 CA008748.
Funding Information:
We thank the participants and their families and caregivers, all primary investigators and their site personnel; Cathy Pietanza for study support (Merck & Co., Inc., Rahway, NJ, USA); and Ina Nikolaeva (Merck & Co., Inc., Rahway, NJ, USA) for medical writing assistance. This study and assistance with manuscript editing were funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ, USA . Dr. Rimner was funded in part through the NIH/NCI Cancer Center Support Grant P30 CA008748 .
Publisher Copyright:
© 2022
PY - 2022/7/1
Y1 - 2022/7/1
N2 - BACKGROUND: The current standard of care for patients with newly diagnosed limited-stage small-cell lung cancer (SCLC) is concurrent chemoradiotherapy (CCRT). The prognosis remains poor due to the aggressiveness and high risk of progression or relapse of SCLC even if an initial response is achieved. Therefore, there is an urgent unmet clinical need in this population. The multicenter, phase 3, randomized, placebo-controlled, double-blind KEYLYNK-013 study evaluates the addition of pembrolizumab to CCRT followed by pembrolizumab with or without olaparib in participants with previously untreated limited-stage SCLC. (ClinicalTrials.gov: NCT04624204).METHODS: Eligible participants aged ≥18 years with newly diagnosed, pathologically confirmed, limited-stage (ie, stage I-III) SCLC will be randomized 1:1:1 to CCRT (ie, etoposide plus carboplatin or cisplatin for 4 cycles and standard thoracic radiotherapy) plus pembrolizumab (Groups A and B) or CCRT plus placebo (Group C). In the absence of disease progression, participants will receive pembrolizumab plus placebo (Group A), pembrolizumab plus olaparib (Group B), or placebo (Group C). Dual primary endpoints are progression-free survival per RECIST version 1.1 by blinded independent central review and overall survival.RESULTS: Enrollment began in December 2020 and is ongoing at approximately 150 sites.CONCLUSIONS: KEYLYNK-013 will provide valuable information on the efficacy and safety of pembrolizumab plus CCRT and pembrolizumab with or without olaparib post CCRT in participants with limited-stage SCLC.
AB - BACKGROUND: The current standard of care for patients with newly diagnosed limited-stage small-cell lung cancer (SCLC) is concurrent chemoradiotherapy (CCRT). The prognosis remains poor due to the aggressiveness and high risk of progression or relapse of SCLC even if an initial response is achieved. Therefore, there is an urgent unmet clinical need in this population. The multicenter, phase 3, randomized, placebo-controlled, double-blind KEYLYNK-013 study evaluates the addition of pembrolizumab to CCRT followed by pembrolizumab with or without olaparib in participants with previously untreated limited-stage SCLC. (ClinicalTrials.gov: NCT04624204).METHODS: Eligible participants aged ≥18 years with newly diagnosed, pathologically confirmed, limited-stage (ie, stage I-III) SCLC will be randomized 1:1:1 to CCRT (ie, etoposide plus carboplatin or cisplatin for 4 cycles and standard thoracic radiotherapy) plus pembrolizumab (Groups A and B) or CCRT plus placebo (Group C). In the absence of disease progression, participants will receive pembrolizumab plus placebo (Group A), pembrolizumab plus olaparib (Group B), or placebo (Group C). Dual primary endpoints are progression-free survival per RECIST version 1.1 by blinded independent central review and overall survival.RESULTS: Enrollment began in December 2020 and is ongoing at approximately 150 sites.CONCLUSIONS: KEYLYNK-013 will provide valuable information on the efficacy and safety of pembrolizumab plus CCRT and pembrolizumab with or without olaparib post CCRT in participants with limited-stage SCLC.
KW - concurrent chemoradiotherapy
KW - Limited-stage SCLC
KW - Olaparib
KW - pembrolizumab
UR - https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=pure_starter&SrcAuth=WosAPI&KeyUT=WOS:000824570500003&DestLinkType=FullRecord&DestApp=WOS
UR - https://www.mendeley.com/catalogue/77f472fd-d3ae-33fc-86ab-43561ad42501/
U2 - 10.1016/j.cllc.2022.04.005
DO - 10.1016/j.cllc.2022.04.005
M3 - Article
C2 - 35613997
SN - 1525-7304
VL - 23
SP - e325-e329
JO - Clinical Lung Cancer
JF - Clinical Lung Cancer
IS - 5
ER -
