Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer (ROSETTA Lung-02)
Public ClinicalTrials.gov record NCT06712316. 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 II/III, Multisite, Randomized Master Protocol for a Global Trial of BNT327 in Combination With Chemotherapy and Other Investigational Agents in First-line Non-small Cell Lung Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06712316
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 1,580 participants
Conditions and interventions
Conditions
Interventions
- Pumitamig Drug
- Pembrolizumab Drug
- Carboplatin Drug
- Pemetrexed Drug
- Paclitaxel Drug
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
- Jan 7, 2025 (Actual)
- Primary completion
- Jan 2029 (Estimated)
- Completion
- Dec 2031 (Estimated)
- Last update posted
- Oct 15, 2026
2025 – 2031
United States locations
- U.S. sites
- 53
- U.S. states
- 24
- U.S. cities
- 49
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Birmingham Hematology and Oncology Associates LLC d/b/a Alabama Oncology | Birmingham | Alabama | 35223 | Recruiting |
| Alaska Oncology and Hematology, LLC | Anchorage | Alaska | 99508 | Recruiting |
| John Muir Clinical Research Center | Concord | California | 94520 | Recruiting |
| University Of California - San Diego Moores Cancer Center | La Jolla | California | 92093 | Recruiting |
| Vail Health | Vail | Colorado | 81657 | Recruiting |
| MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH) | Washington D.C. | District of Columbia | 20007 | Recruiting |
| MEDSTAR Washington Hospital Center (MedStar Health Research Institute) | Washington D.C. | District of Columbia | 20010 | Recruiting |
| Clermont Oncology Center | Clermont | Florida | 34711 | Recruiting |
| SSAK Partners, LLC. | Coral Springs | Florida | 33065 | Recruiting |
| Baptist Medical Center Jacksonville | Jacksonville | Florida | 32207 | Recruiting |
| Mid Florida Cancer Centers | Orange City | Florida | 32763 | Recruiting |
| Cleveland Clinic Florida - Martin North Hospital | Stuart | Florida | 34994 | Recruiting |
| H. Lee Moffit Cancer center and research institute | Tampa | Florida | 33612 | Recruiting |
| Cleveland Clinic Weston Hospital | Weston | Florida | 33331 | Recruiting |
| Northwest Georgia Oncology Centers, P.C. | Marietta | Georgia | 30060 | Recruiting |
| Fort Wayne Medical Oncology and Hematology, Inc. | Fort Wayne | Indiana | 46845 | Recruiting |
| Indiana University Health University Hospital | Indianapolis | Indiana | 46202 | Recruiting |
| Physicians Clinic of Iowa | Cedar Rapids | Iowa | 52401-2112 | Recruiting |
| Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | Recruiting |
| Baptist Health Hardin | Elizabethtown | Kentucky | 42701 | Recruiting |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | Recruiting |
| University of Kentucky Chandler Medical Center (UKCMC) - Markey Cancer Center (Lucille P. Markey Cancer Center) | Lexington | Kentucky | 40536 | Recruiting |
| Frederick Health Hospital- James M Stockman Cancer Institute | Frederick | Maryland | 21704 | Recruiting |
| Missouri Cancer Associates | Columbia | Missouri | 65201 | Recruiting |
| SSM Health Cancer Care - St. Clare | Fenton | Missouri | 63026 | Withdrawn |
| Mary Lanning Healthcare (MLH) - Morrison Cancer Center (MCC) | Hastings | Nebraska | 68901-4470 | Recruiting |
| Astera Cancer Care | East Brunswick | New Jersey | 08816 | Recruiting |
| Summit Medical Group PA | Florham Park | New Jersey | 07932 | Recruiting |
| The Valley Hospital - Valley Health System - The Robert and Audrey Luckow Pavilion | Paramus | New Jersey | 07652 | Recruiting |
| Nuvance Health | Poughkeepsie | New York | 12601 | Recruiting |
| Suny-Stony Brook University Cancer Center | Stony Brook | New York | 11794-9446 | Recruiting |
| White Plains Hospital | White Plains | New York | 10601 | Recruiting |
| Fletcher Hospital, Inc. dba AdventHealth Hendersonville | Hendersonville | North Carolina | 28792 | Recruiting |
| Gabrail Cancer Center Research | Canton | Ohio | 44718 | Recruiting |
| The Christ Hospital Cancer Center | Cincinnati | Ohio | 45219 | Recruiting |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | Recruiting |
| The Cleveland Clinic Cancer Center At Fairview Hospital, Moll Pavilion | Cleveland | Ohio | 44111 | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | 44195-0001 | Recruiting |
| Dayton Physicians Network | Dayton | Ohio | 45415 | Recruiting |
| Kettering Medical Center | Kettering | Ohio | 45429 | Recruiting |
| Cleveland Clinic - Hillcrest Hospital | Mayfield Heights | Ohio | 44124 | Recruiting |
| INTEGRIS Cancer Institute of Oklahoma | Oklahoma City | Oklahoma | 73109 | Recruiting |
| University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | Recruiting |
| Baptist Cancer Center | Memphis | Tennessee | 38120 | Withdrawn |
| Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | Recruiting |
| Millennium Research and Clinical Development, LLC | Houston | Texas | 77090 | Active, not recruiting |
| Utah Cancer Specialists | Salt Lake City | Utah | 84106 | Recruiting |
| Virginia Cancer Specialists - Arlington | Arlington | Virginia | 22201 | Recruiting |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | Recruiting |
| VCU Massey Cancer Center | Richmond | Virginia | 23298 | Recruiting |
| Shenandoah Oncology | Winchester | Virginia | 22601 | Recruiting |
| West Virginia University Hospitals - Mary Babb Randolph Cancer Center | Morgantown | West Virginia | 26506-8110 | Recruiting |
| Gundersen Lutheran Medical Center | La Crosse | Wisconsin | 54601-5467 | Recruiting |
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 312 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06712316, 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 15, 2026 · Synced Oct 19, 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 NCT06712316 live on ClinicalTrials.gov.