NCT03066778

A Study of Pembrolizumab (MK-3475) in Combination With Etoposide/Platinum (Cisplatin or Carboplatin) for Participants With Extensive Stage Small Cell Lung Cancer (MK-3475-604/KEYNOTE-604)

A Phase 3 Randomized, Double-Blind, Placebo-controlled Trial of Pembrolizumab (MK-3475/SCH900475) in Combination With Etoposide/Platinum (Cisplatin or Carboplatin) for the First-line Treatment of Subjects With Extensive Stage Small Cell Lung Cancer (KEYNOTE-604)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 453 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and efficacy of pembrolizumab plus standard of care (SOC) chemotherapy (etoposide/platinum \[EP\]) in participants with newly diagnosed extensive stage small cell lung cancer (ES-SCLC) who have not previously received systemic therapy for this malignancy. The primary study hypotheses are that pembrolizumab+EP prolongs Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR) and Overall Survival (OS) compared with placebo+EP in adult participants with ES-SCLC. In this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. With protocol Amendment 07 (03-Oct-2018), the outcome measure of "Change from Baseline at Weeks 12 and 24 in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Global Health Status/Quality of Life Scale" was replaced with a single time point analysis at Week 18.

Conditions

• Small Cell Lung Cancer (SCLC)

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	IV infusion on Day 1 of each cycle prior to chemotherapy
DRUG	Normal saline solution	IV infusion on Day 1 of each cycle prior to chemotherapy
DRUG	Carboplatin	IV infusion on Day 1 of each cycle
DRUG	Cisplatin	IV infusion on Day 1 of each cycle
DRUG	Etoposide	IV infusion on Days 1, 2 and 3 of each cycle

Timeline

• Start date: 2017-05-02
• Primary completion: 2019-12-02
• Completion: 2021-09-21
• First posted: 2017-02-28
• Last updated: 2022-10-03
• Results posted: 2020-12-22

Locations

148 sites across 19 countries: United States, Australia, Canada, Chile, France, Germany, Hungary, Ireland, Israel, Japan, New Zealand, Poland, Russia, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study