OncRef

Clinical Trial: NCT03850444

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

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:Merck Sharp & Dohme LLC
Information Provided By:Merck Sharp & Dohme LLC
Last Update Posted:2023-09-18

Study Overview

Brief 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.

Official Title

A Randomized, Open Label, Phase III Study of Overall Survival Comparing Pembrolizumab (MK-3475) Versus Platinum Based Chemotherapy in Treatment Naïve Subjects With PD-L1 Positive Advanced or Metastatic Non-Small Cell Lung Cancer (Keynote 042)

Conditions

Non-small Cell Lung Cancer

Intervention / Treatment

  • Biological: pembrolizumab
  • Drug: carboplatin
  • Drug: paclitaxel
  • Drug: pemetrexed

Other Study ID Numbers

  • 3475-042 China Extension
  • 152877
  • MK-3475-042
  • KEYNOTE-042

Start Date (Actual)

2016-08-01

Primary Completion Date (Actual)

2018-09-04

Study Completion Date (Actual)

2022-09-08

Enrollment (Actual)

262

Study Type

Interventional

Phase

Phase 3