M7824 Versus Pembrolizumab as a First-line (1L) Treatment in Participants With Programmed Death-ligand 1 (PD-L1) Expressing Advanced Non-small Cell Lung Cancer (NSCLC)
Public ClinicalTrials.gov record NCT03631706. 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
An Adaptive Phase III, Multicenter, Randomized, Open-Label, Controlled Study of M7824 (Bintrafusp Alfa) Versus Pembrolizumab as a First-line Treatment in Patients With PD-L1 Expressing Advanced Non-small Cell Lung Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of the study is to evaluate the efficacy and safety of bintrafusp alfa (M7824) compared with pembrolizumab in participants with advanced NSCLC with high PD-L1-tumor expression, with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. The Phase III adaptive design allows for the option to recruit up to 584 patients based on pre-specified rules.
Study identification
- NCT ID
- NCT03631706
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 304 participants
Conditions and interventions
Conditions
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
- Oct 1, 2018 (Actual)
- Primary completion
- Jun 7, 2021 (Actual)
- Completion
- Jun 25, 2024 (Actual)
- Last update posted
- Apr 8, 2025
2018 – 2024
United States locations
- U.S. sites
- 25
- U.S. states
- 17
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Oncology Specialties, PC; Clearview Cancer Institute | Huntsville | Alabama | 35805 | — |
| Cedars Sinai Medical Center - Inflammatory Bowel Disease Center (Clinic | Los Angeles | California | 90048 | — |
| UC Irvine Medical Center | Orange | California | 92868 | — |
| Kaiser Permanente - Harbor City | San Diego | California | 92120 | — |
| Sansum Clinic - Santa Barbara | Santa Barbara | California | 93105 | — |
| Rocky Mountain Cancer Centers - Colorado Springs, N. Nevada | Colorado Springs | Colorado | 80907 | — |
| Eastern Connecticut Hematology/Oncology Assoc. | Norwich | Connecticut | 06360 | — |
| Cancer Specialists, LLC - Department of Clinical Research | Jacksonville | Florida | 32256 | — |
| Woodlands Medical Specialists | Pensacola | Florida | 32503 | — |
| The University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| Decatur Memorial Hospital - Clinical Research | Decatur | Illinois | 62526 | — |
| Baptist Health Lexington Oncology Associates | Lexington | Kentucky | 40503 | — |
| Norton Cancer Institute | Louisville | Kentucky | 40202 | — |
| Henry Ford Medical Center | Detroit | Michigan | 48202 | — |
| Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC - Menorah Medical Center - Oncology Account | Kansas City | Missouri | 64132 | — |
| Southeast Nebraska Cancer Center | Lincoln | Nebraska | 68510 | — |
| The Valley Hospital - Luckow Pavilion | Paramus | New Jersey | 07652 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| UPMC Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| SCRI - Tennessee Oncology | Nashville | Tennessee | 37203 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Texas Oncology - Bedford | Bedford | Texas | 76022 | — |
| Texas Oncology, P.A. - Sugarland | Sugar Land | Texas | 77479 | — |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | — |
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 94 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03631706, 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 Apr 8, 2025 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03631706 live on ClinicalTrials.gov.