Study of Pembrolizumab (MK-3475) Versus Platinum-Based Chemotherapy for Participants With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Advanced or Metastatic Non-Small Cell Lung Cancer (MK-3475-042/KEYNOTE-042)-China Extension Study

Summary

In the China extension study, Chinese participants with programmed cell death ligand 1 (PD-L1)-positive non-small cell lung cancer (NSCLC) will be randomized to receive single agent pembrolizumab for up to 35 treatments or standard of care (SOC) platinum-based chemotherapy (carboplatin + paclitaxel or carboplatin + pemetrexed for 4 to 6 21-day cycles). Chinese participants in the platinum-based chemotherapy arms with non-squamous tumor histologies may receive pemetrexed maintenance therapy after the 4 to 6 cycles of chemotherapy. The primary extension study hypothesis is that pembrolizumab prolongs overall survival (OS) compared to SOC chemotherapy in Chinese participants.

Timeline

Start

2016-08-01

Primary completion

2018-09-04

Completion

2022-09-08

Outcome

Mixed primary results

registry analysis (other test); Pembrolizumab vs Chemotherapy (SOC Treatment); Hazard Ratio (HR) 0.62 (95% CI 0.38 to 1.00) NCT03850444 ↗

registry analysis (other test); Pembrolizumab vs Chemotherapy (SOC Treatment); Hazard Ratio (HR) 0.62 (95% CI 0.41 to 0.95) NCT03850444 ↗

registry analysis (other test); Pembrolizumab vs Chemotherapy (SOC Treatment); Hazard Ratio (HR) 0.65 (95% CI 0.45 to 0.94) NCT03850444 ↗

Publications

• Results Wu YL, Zhang L, Fan Y, Zhou J, Zhang L, Zhou Q, Li W, Hu C, Chen G, Zhang X, Zhou C, Dang T, Sadowski S, Kush DA, Zhou Y, Li B, Mok T. Randomized clinical trial of pembrolizumab vs chemotherapy for previously untreated Chinese patients with PD-L1-positive locally advanced or metastatic non-small-cell lung cancer: KEYNOTE-042 China Study. Int J Cancer. 2021 May 1;148(9):2313-2320. doi: 10.1002/ijc.33399. Epub 2020 Dec 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Carboplatin	Small molecule	5 unknown	Intravenous
Comparator	Carboplatin	Small molecule	6 unknown	Intravenous
Comparator	Paclitaxel	Small molecule	200 mg/m2	Intravenous
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous
Comparator	Pemetrexed	Small molecule	500 mg/m2	Intravenous

Indications