KEYNOTE‐033: Randomized phase 3 study of pembrolizumab vs docetaxel in previously treated, PD‐L1‐positive, advanced NSCLC

KEYNOTE‐033 (NCT02864394) was a multicountry, open‐label, phase 3 study that compared pembrolizumab vs docetaxel in previously treated, programmed death‐ligand 1 (PD‐L1)‐positive, advanced non‐small cell lung cancer (NSCLC), with most patients enrolled in mainland China. Eligible patients were rando...

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Published in:International journal of cancer 2023-08, Vol.153 (3), p.623-634
Main Authors: Ren, Shengxiang, Feng, Jifeng, Ma, Shenglin, Chen, HuaJun, Ma, Zhiyong, Huang, Cheng, Zhang, Li, He, Jianxing, Wang, Changli, Zhou, Jianying, Danchaivijtr, Pongwut, Wang, Chin‐Chou, Vynnychenko, Ihor, Wang, Kai, Orlandi, Francisco, Sriuranpong, Virote, Li, Ben, Ge, Jun, Dang, Thao, Zhou, Caicun
Format: Article
Language:English
Subjects:
Apoptosis
B7-H1 Antigen
Cancer
Carcinoma, Non-Small-Cell Lung - pathology
Docetaxel - adverse effects
Humans
immunotherapy
Lung cancer
Lung Neoplasms - pathology
Medical research
Non-small cell lung carcinoma
NSCLC
PD-L1 protein
Pembrolizumab
programmed death 1
programmed death‐ligand 1
Small cell lung carcinoma
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Summary:KEYNOTE‐033 (NCT02864394) was a multicountry, open‐label, phase 3 study that compared pembrolizumab vs docetaxel in previously treated, programmed death‐ligand 1 (PD‐L1)‐positive, advanced non‐small cell lung cancer (NSCLC), with most patients enrolled in mainland China. Eligible patients were randomized (1:1) to pembrolizumab 2 mg/kg or docetaxel 75 mg/m2 every 3 weeks. Primary endpoints were overall survival (OS) and progression‐free survival and were evaluated sequentially using stratified log‐rank tests, first in patients with PD‐L1 tumor proportion score (TPS) ≥50% and then in patients with PD‐L1 TPS ≥1% (significance threshold: P 
ISSN:0020-7136
1097-0215
DOI:10.1002/ijc.34532