Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer (ROSETTA Lung-02)
NCT06712316
This study is recruiting at 50 US sites in 23 states, according to its ClinicalTrials.gov record last updated .
Summary
This is a Phase 2/3, multisite, randomized, open-label study in participants with first-line non-small cell lung cancer (NSCLC). This study includes two substudies (substudy A and substudy B) that will recruit participants according to histological subtypes due to differences in chemotherapy choice for standard-of-care and type of NSCLC.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Non-small Cell Lung Cancer
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 2/3
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- BioNTech SE
- Last updated on ClinicalTrials.gov
- October 15, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Alabama · 1
- Birmingham Hematology and Oncology Associates LLC d/b/a Alabama Oncology · Birmingham, AL
Alaska · 1
- Alaska Oncology and Hematology, LLC · Anchorage, AK
California · 2
- John Muir Clinical Research Center · Concord, CA
- University Of California - San Diego Moores Cancer Center · La Jolla, CA
Colorado · 1
- Vail Health · Vail, CO
District of Columbia · 2
- MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH) · Washington D.C., DC
- MEDSTAR Washington Hospital Center (MedStar Health Research Institute) · Washington D.C., DC
Florida · 7
- Clermont Oncology Center · Clermont, FL
- SSAK Partners, LLC. · Coral Springs, FL
- Baptist Medical Center Jacksonville · Jacksonville, FL
- Mid Florida Cancer Centers · Orange City, FL
- Cleveland Clinic Florida - Martin North Hospital · Stuart, FL
- H. Lee Moffit Cancer center and research institute · Tampa, FL
- Cleveland Clinic Weston Hospital · Weston, FL
Georgia · 1
- Northwest Georgia Oncology Centers, P.C. · Marietta, GA
Indiana · 2
- Fort Wayne Medical Oncology and Hematology, Inc. · Fort Wayne, IN
- Indiana University Health University Hospital · Indianapolis, IN
Iowa · 2
- Physicians Clinic of Iowa · Cedar Rapids, IA
- Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics · Iowa City, IA
Kentucky · 3
- Baptist Health Hardin · Elizabethtown, KY
- Baptist Health Lexington · Lexington, KY
- University of Kentucky Chandler Medical Center (UKCMC) - Markey Cancer Center (Lucille P. Markey Cancer Center) · Lexington, KY
Maryland · 1
- Frederick Health Hospital- James M Stockman Cancer Institute · Frederick, MD
Missouri · 1
- Missouri Cancer Associates · Columbia, MO
Nebraska · 1
- Mary Lanning Healthcare (MLH) - Morrison Cancer Center (MCC) · Hastings, NE
New Jersey · 3
- Astera Cancer Care · East Brunswick, NJ
- Summit Medical Group PA · Florham Park, NJ
- The Valley Hospital - Valley Health System - The Robert and Audrey Luckow Pavilion · Paramus, NJ
New York · 3
- Nuvance Health · Poughkeepsie, NY
- Suny-Stony Brook University Cancer Center · Stony Brook, NY
- White Plains Hospital · White Plains, NY
North Carolina · 1
- Fletcher Hospital, Inc. dba AdventHealth Hendersonville · Hendersonville, NC
Ohio · 8
- Gabrail Cancer Center Research · Canton, OH
- The Christ Hospital Cancer Center · Cincinnati, OH
- University of Cincinnati Medical Center · Cincinnati, OH
- Cleveland Clinic · Cleveland, OH
- The Cleveland Clinic Cancer Center At Fairview Hospital, Moll Pavilion · Cleveland, OH
- Dayton Physicians Network · Dayton, OH
- Kettering Medical Center · Kettering, OH
- Cleveland Clinic - Hillcrest Hospital · Mayfield Heights, OH
Oklahoma · 1
- INTEGRIS Cancer Institute of Oklahoma · Oklahoma City, OK
Tennessee · 2
- University of Tennessee Medical Center · Knoxville, TN
- Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center · Nashville, TN
Utah · 1
- Utah Cancer Specialists · Salt Lake City, UT
Virginia · 4
- Virginia Cancer Specialists - Arlington · Arlington, VA
- Virginia Cancer Specialists · Fairfax, VA
- VCU Massey Cancer Center · Richmond, VA
- Shenandoah Oncology · Winchester, VA
West Virginia · 1
- West Virginia University Hospitals - Mary Babb Randolph Cancer Center · Morgantown, WV
Wisconsin · 1
- Gundersen Lutheran Medical Center · La Crosse, WI
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.