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Rationale and Design of the Phase III KEYLYNK-012 Study of Pembrolizumab and Concurrent Chemoradiotherapy Followed by Pembrolizumab With or Without Olaparib for Stage III Non-Small-Cell Lung Cancer

Authors
 Salma K Jabbour  ;  Byoung Chul Cho  ;  Emilio Bria  ;  Terufumi Kato  ;  Jaishree Bhosle  ;  Justin F Gainor  ;  Noemi Reguart  ;  Luhua Wang  ;  Daniel Morgensztern  ;  Yue Shentu  ;  Sung Jin Kim  ;  Fabricio Souza  ;  Martin Reck 
Citation
 CLINICAL LUNG CANCER, Vol.23(6) : e342-e346, 2022-09 
Journal Title
CLINICAL LUNG CANCER
ISSN
 1525-7304 
Issue Date
2022-09
MeSH
Adolescent ; Adult ; Antibodies, Monoclonal, Humanized ; Antineoplastic Combined Chemotherapy Protocols / therapeutic use ; Carcinoma, Non-Small-Cell Lung* / drug therapy ; Chemoradiotherapy ; Disease Progression ; Humans ; Lung Neoplasms* / drug therapy ; Phthalazines ; Piperazines
Keywords
Chemotherapy ; Immunotherapy ; Non-small-cell lung cancer ; PARP inhibition ; Radiation therapy
Abstract
Background: Concurrent chemoradiotherapy is a standard therapy for patients with stage III non-small-cell lung cancer (NSCLC). Durvalumab is an approved treatment option following concurrent chemoradiotherapy in the absence of disease progression. The multicenter, phase III, randomized, placebo- and active-controlled, double-blind KEYLYNK-012 study evaluates whether initiation of immunotherapy with pembrolizumab concurrently with chemoradiotherapy, followed by post-chemoradiotherapy pembrolizumab with or without olaparib improves outcomes for participants with stage III NSCLC. (ClinicalTrials.gov: NCT04380636) METHODS: Eligible participants are aged ≥18 years with previously untreated, pathologically confirmed, stages IIIA-C, squamous or nonsquamous NSCLC not suitable for surgery with curative intent. Participants will be randomized 1:1:1 to platinum-doublet chemotherapy plus radiotherapy with pembrolizumab (Groups A and B) or concurrent chemoradiotherapy alone (Group C) for 3 cycles. In the absence of disease progression, participants will receive pembrolizumab plus olaparib placebo (Group A), pembrolizumab plus olaparib (Group B), or durvalumab monotherapy (Group C). Dual primary endpoints are progression-free survival per RECIST version 1.1 by independent central review and overall survival.

Results: Enrollment began on July 6, 2020, and is ongoing at approximately 190 sites.

Conclusion: KEYLYNK-012 will provide important information on the efficacy and safety of pembrolizumab combined with concurrent chemoradiotherapy and subsequent pembrolizumab with or without olaparib in participants with unresectable stage III NSCLC.
Files in This Item:
T202204483.pdf Download
DOI
10.1016/j.cllc.2022.04.003
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Cho, Byoung Chul(조병철) ORCID logo https://orcid.org/0000-0002-5562-270X
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/191926
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