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)
Public ClinicalTrials.gov record NCT03066778. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03066778
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 453 participants
Conditions and interventions
Conditions
Interventions
- Pembrolizumab Biological
- Normal saline solution Drug
- Carboplatin Drug
- Cisplatin Drug
- Etoposide Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 2, 2017 (Actual)
- Primary completion
- Dec 2, 2019 (Actual)
- Completion
- Sep 21, 2021 (Actual)
- Last update posted
- Oct 3, 2022
2017 – 2021
United States locations
- U.S. sites
- 27
- U.S. states
- 16
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Baptist Health Medical Group Oncology, LLC ( Site 8000) | Miami | Florida | 33176 | — |
| Rush University Medical Center ( Site 1215) | Chicago | Illinois | 60612 | — |
| North Shore University Health System ( Site 1216) | Evanston | Illinois | 60201 | — |
| Community Hospital ( Site 1207) | Munster | Indiana | 46321 | — |
| Weinberg Cancer Institute at Franklin Square ( Site 1210) | Baltimore | Maryland | 21237 | — |
| Massachusetts General Hospital ( Site 1203) | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess Medical Center ( Site 1206) | Boston | Massachusetts | 02215 | — |
| Dana-Farber Cancer Institute [Boston] ( Site 1201) | Boston | Massachusetts | 02215 | — |
| University of Michigan ( Site 1217) | Ann Arbor | Michigan | 48109-5936 | — |
| Henry Ford Health System ( Site 1221) | Detroit | Michigan | 48202 | — |
| Minnesota Oncology Hematology, PA ( Site 8001) | Minneapolis | Minnesota | 55404 | — |
| Hattiesburg Clinic ( Site 1205) | Hattiesburg | Mississippi | 39401 | — |
| Mercy Hospital Saint Louis ( Site 1213) | St Louis | Missouri | 63141 | — |
| Comprehensive Cancer Centers of Nevada ( Site 8004) | Henderson | Nevada | 89074 | — |
| Memorial Sloan-Kettering Cancer Center At Basking Ridge ( Site 1226) | Basking Ridge | New Jersey | 07920 | — |
| Memorial Sloan Kettering Cancer Center- Monmouth ( Site 1225) | Middletown | New Jersey | 07748 | — |
| Memorial Sloan-Kettering Cancer Center at Commack ( Site 1227) | Commack | New York | 11725 | — |
| Memorial Sloan Kettering Cancer Center ( Site 1229) | Harrison | New York | 10604 | — |
| Memorial Sloan Kettering Cancer Center ( Site 1211) | New York | New York | 10065 | — |
| Memorial Sloan Kettering Cancer Center - Rockville Centre ( Site 1228) | Rockville Centre | New York | 11570 | — |
| Montefiore Einstein Center for Cancer Care - Main site ( Site 1204) | The Bronx | New York | 10461 | — |
| Montefiore Medical Center ( Site 1222) | The Bronx | New York | 10467 | — |
| Duke University Medical Center ( Site 1214) | Durham | North Carolina | 27710 | — |
| Bon Secours St. Francis Health Sytem ( Site 1212) | Greenville | South Carolina | 29607 | — |
| Tennessee Oncology, PLLC/The Sarah Cannon Research Institute ( Site 1230) | Nashville | Tennessee | 37203 | — |
| Texas Oncology ( Site 8002) | Austin | Texas | 78745 | — |
| Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 8003) | Dallas | Texas | 75246 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 121 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03066778, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 3, 2022 · Synced Oct 29, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03066778 live on ClinicalTrials.gov.