Study of Pembrolizumab Versus Docetaxel in Participants Previously Treated for Non-Small Cell Lung Cancer (MK-3475-033/KEYNOTE-033)

Summary

The purpose of this study is to assess the efficacy of pembrolizumab (MK-3475) versus docetaxel in participants with non-small cell lung cancer (NSCLC) with programmed cell death ligand 1 (PD-L1) positive tumors who have experienced disease progression after platinum-containing systemic therapy. The primary hypotheses of this study are that pembrolizumab (MK-3475) prolongs overall survival (OS) and that pembrolizumab prolongs progression-free survival (PFS), compared to docetaxel in participants with PD-L1 positive tumors.

Timeline

Start

2016-09-07

Primary completion

2019-09-09

Completion

2022-10-14

Outcome

Missed primary endpoint

paper Because the significance threshold was not met, sequential testing of OS and PFS was ceased. PMID 37141294 ↗

registry analysis (superiority test); Pembrolizumab vs Docetaxel; p = 0.1276; Hazard Ratio (HR) 0.83 (95% CI 0.61 to 1.14); Log Rank NCT02864394 ↗

Publications

• Results Ren S, Feng J, Ma S, Chen H, Ma Z, Huang C, Zhang L, He J, Wang C, Zhou J, Danchaivijtr P, Wang CC, Vynnychenko I, Wang K, Orlandi F, Sriuranpong V, Li B, Ge J, Dang T, Zhou C. KEYNOTE-033: Randomized phase 3 study of pembrolizumab vs docetaxel in previously treated, PD-L1-positive, advanced NSCLC. Int J Cancer. 2023 Aug 1;153(3):623-634. doi: 10.1002/ijc.34532. Epub 2023 May 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Docetaxel	Small molecule	75 mg/m2	Intravenous
Subject	Pembrolizumab	Monoclonal antibody	2 mg/kg	Intravenous

Indications