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

Authors

Andreas Rimner
Wei-Chu Victoria Lai
Raffaele Califano
Salma K Jabbour
Charles M Rudin
Corinne Faivre-Finn
Byoung Chul Cho
Terufumi Kato
Jinming Yu
Wyatt Chafin
Li Yu
Bin Zhao
Lauren Byers

Publication Date

7-1-2022

Journal

Clinical Lung Cancer

Abstract

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.

Keywords

Adolescent, Adult, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols, Carboplatin, Chemoradiotherapy, Clinical Trials, Phase III as Topic, Etoposide, Humans, Lung Neoplasms, Multicenter Studies as Topic, Neoplasm Recurrence, Local, Phthalazines, Piperazines, Randomized Controlled Trials as Topic, Small Cell Lung Carcinoma

DOI

10.1016/j.cllc.2022.04.005

PMID

35613997

PMCID

PMC10905605

PubMedCentral® Posted Date

3-1-2024

PubMedCentral® Full Text Version

Author MSS

Published Open-Access

yes