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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) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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)

NCT03066778•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Has a documented new diagnosis of SCLC by histology or cytology from brushing, washing, or needle aspiration of a defined lesion. Participants who do not have histology samples (defined as core or excisional biopsy, or resections) will need to undergo a new biopsy to provide a tissue sample.
•Has extensive-stage disease defined as Stage IV (T any, N any, M 1a/b) by the American Joint Committee on Cancer (AJCC), Seventh Edition
•Has ≥1 lesion that meets the criteria for measurable, as defined by RECIST 1.1, and is appropriate for selection as a target lesion, as determined by local site investigator/radiology assessment
•Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
•Has Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
•Has a life expectancy of ≥3 months
•Has adequate organ function
•Female and male participants of childbearing potential must be willing to use an adequate method of contraception, starting with the first dose of study treatment through 120 days after the last dose of study treatment and up to 180 days after last dose of chemotherapeutic agents

Exclusion Criteria

•Has received prior systemic therapy for the treatment of SCLC
•Is currently participating and receiving study treatment or has participated in a study of an investigational agent and received study treatment or used an investigational device within 4 weeks of the first dose of treatment for another health-related problem
•Is expected to require any other form of antineoplastic therapy for SCLC, including radiation therapy, while on study. (Prophylactic cranial irradiation will be possible for those participants with stable disease or better at the completion of the 4 cycles of chemotherapy with or without pembrolizumab.)
•Has known central nervous system (ie, brain and/or spinal cord) metastases and/or carcinomatous meningitis. Participants with brain metastases may participate only if they satisfy all of the following:
•Has completed treatment (eg, whole brain radiation treatment \[WBRT\], stereotactic radiosurgery, or equivalent) ≥14 days prior to the first dose of study treatment,
•Has no evidence of new or enlarging brain metastases confirmed by post-treatment repeat brain imaging performed ≥3 weeks after pre-treatment brain imaging, and
•Is neurologically stable without the need for steroids for ≥7 days before first dose of study treatment.
•Has had major surgery within 3 weeks prior to receiving the first dose of study treatment or has not recovered adequately from toxicity and/or complications from an intervention prior to receiving the first dose of study treatment.
•Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
•Has a known history of interstitial lung disease
+16 more criteria

Locations (148)

Baptist Health Medical Group Oncology, LLC ( Site 8000)

Miami, Florida, United States

Rush University Medical Center ( Site 1215)

Chicago, Illinois, United States

North Shore University Health System ( Site 1216)

Evanston, Illinois, United States

Community Hospital ( Site 1207)

Munster, Indiana, United States

Weinberg Cancer Institute at Franklin Square ( Site 1210)

Baltimore, Maryland, United States

Massachusetts General Hospital ( Site 1203)

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center ( Site 1206)

Boston, Massachusetts, United States

Dana-Farber Cancer Institute [Boston] ( Site 1201)

Boston, Massachusetts, United States

University of Michigan ( Site 1217)

Ann Arbor, Michigan, United States

Henry Ford Health System ( Site 1221)

Detroit, Michigan, United States

Key Dates

Start Date

May 2, 2017

Primary Completion Date

December 2, 2019

Completion Date

September 21, 2021

Last Updated

October 3, 2022

Enrollment

453

ACTUAL participants

Conditions

Small Cell Lung Cancer (SCLC)

Interventions

Pembrolizumab

BIOLOGICAL

Normal saline solution

DRUG

Carboplatin

DRUG

Cisplatin

DRUG

Etoposide

DRUG

Study of Irinotecan Liposome Injection as Second-line Regimen in Patients With Small Cell Lung Cancer (SCLC)

NCT04727853

Small Cell Lung Cancer (SCLC)

View study

TERMINATEDNA

Pulmonary Interstitial Lymphography in Early Stage Lung Cancer

NCT01188486

Lung CancerLung Cancer Non-Small Cell Cancer (NSCLC)+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 3, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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