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)

Completed · Phase 3 · Has a placebo group

Conditions studied: Small Cell Lung Cancer (SCLC)

In brief

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.

Key facts

Study ID: NCT03066778
Run by: Merck Sharp & Dohme LLC
People needed: 453
Starts: 2017-05-02
Expected to finish: 2021-09-21
Last updated by the study team: 2022-10-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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
Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or Stage 1) treated with curative intent, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy.
Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is not considered a form of systemic treatment.
Has a known history of, or active, neurologic paraneoplastic syndrome
Has clinically active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, and/or abdominal carcinomatosis
Has a history of a severe hypersensitivity reaction to treatment with another monoclonal antibody
Is taking chronic systemic steroids (in doses exceeding 10 mg daily of prednisone equivalent) within 7 days prior to the first dose of study treatment
Has a diagnosis of immunodeficiency or is receiving any form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
Has received a live vaccine within 30 days prior to the first dose of study treatment
Has received prior therapy with an anti-programmed cell death protein-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-programmed cell death-ligand 2 (anti-PD-L2) agent or with an agent directed to another co-inhibitory T-cell receptor (i.e., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], tumor necrosis factor receptor superfamily member 9 [TNFRSF9, OX-40, CD137]) or has previously participated in a Merck pembrolizumab (MK-3475) clinical trial
Has severe hypersensitivity (Grade ≥3) to pembrolizumab and/or any of its excipients
Has an active infection requiring systemic therapy
Has a known history of human immunodeficiency virus (HIV) infection
Has a known history of Hepatitis B or known active Hepatitis C virus infection
Has a known history of active TB (Bacillus Tuberculosis)
Has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.

Where it is running

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
Minnesota Oncology Hematology, PA ( Site 8001) — Minneapolis, Minnesota, United States
Hattiesburg Clinic ( Site 1205) — Hattiesburg, Mississippi, United States
Mercy Hospital Saint Louis ( Site 1213) — St Louis, Missouri, United States
Comprehensive Cancer Centers of Nevada ( Site 8004) — Henderson, Nevada, United States
Memorial Sloan-Kettering Cancer Center At Basking Ridge ( Site 1226) — Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Cancer Center- Monmouth ( Site 1225) — Middletown, New Jersey, United States
Memorial Sloan-Kettering Cancer Center at Commack ( Site 1227) — Commack, New York, United States
Memorial Sloan Kettering Cancer Center ( Site 1229) — Harrison, New York, United States
Memorial Sloan Kettering Cancer Center ( Site 1211) — New York, New York, United States
Memorial Sloan Kettering Cancer Center - Rockville Centre ( Site 1228) — Rockville Centre, New York, United States
Montefiore Einstein Center for Cancer Care - Main site ( Site 1204) — The Bronx, New York, United States
Montefiore Medical Center ( Site 1222) — The Bronx, New York, United States
Duke University Medical Center ( Site 1214) — Durham, North Carolina, United States
Bon Secours St. Francis Health Sytem ( Site 1212) — Greenville, South Carolina, United States
Tennessee Oncology, PLLC/The Sarah Cannon Research Institute ( Site 1230) — Nashville, Tennessee, United States
Baptist Health Medical Group Oncology, LLC ( Site 8000) — Miami, Florida, United States

Full record on ClinicalTrials.gov

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