A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC)
Recruiting now · Phase 1/Phase 2
Conditions studied: Non-small Cell Lung Cancer
In brief
This is a multi-site, open-label, dose-finding study, consisting of Parts 1, 2a, and 2b to investigate the combination of BNT326 with pumitamig (also known as BNT327 or PM8002) in participants with relapsed, progressive as well as treatment-naïve, advanced/metastatic non-small cell lung cancer (NSCLC). This study will enroll adult participants with histologically or cytologically confirmed NSCLC that is advanced (i.e., either metastatic or recurrent tumors with no known curative treatment available). The main goals of this study are: 1. To find the best dose levels (DLs) for the combination of BNT326 and pumitamig. 2. To look at how well participants with advanced NSCLC tolerate the combination therapy (for example, which side effects participants experience and how severe they are). 3. To look at how well the combination therapy works to shrink the tumor in participants with advanced NSCLC.
Key facts
- Study ID
- NCT07111520
- Run by
- BioNTech SE
- People needed
- 880
- Starts
- 2025-09-22
- Expected to finish
- 2030-06-01
- Last updated by the study team
- 2026-08-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Stanford Cancer Institute — Stanford, California, United States (enrolling)
- Yale University — New Haven, Connecticut, United States (enrolling)
- Georgetown University - Lombardi Comprehensive Cancer Center — Washington D.C., District of Columbia, United States (enrolling)
- Moffit Cancer Center — Tampa, Florida, United States (enrolling)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
- Henry Ford Health System — Detroit, Michigan, United States (enrolling)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
- Cleveland Clinic Taussig Cancer Institute Case Comprehensive Cancer Center — Cleveland, Ohio, United States (enrolling)
- University of Texas M. D. Anderson Cancer Center — Houston, Texas, United States (enrolling)
- NEXT Virginia — Fairfax, Virginia, United States (enrolling)
- Cancer Research SA — Adelaide, Australia (enrolling)
- St George Private Hospital — Kogarah, Australia (enrolling)
- Royal North Shore Hospital — Saint Leonards, Australia (enrolling)
- Mater — South Brisbane, Australia (enrolling)
- John Flynn Private Hospital — Tugun, Australia (enrolling)
- Westmead Hospital — Westmead, Australia (enrolling)
- Affiliated Hospital of Hebei University — Baoding, China (enrolling)
- Beijing GoBroad Hospital — Beijing, China (enrolling)
- The First Hospital of Jilin University — Changchun, China (enrolling)
- West China Hospital, Sichuan University — Chengdu, China (enrolling)
- Chongqing University Cancer Hospital — Chongqing, China (enrolling)
- Fujian Provincial Cancer Hospital — Fuzhou, China (enrolling)
- The First Affiliated Hospital School of Clinical Medicine of Guangdong Pharmaceutical University — Guangzhou, China (enrolling)
- The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, China (enrolling)
- UCLA Hematology Oncology - Main Site — Los Angeles, California, United States (enrolling)
Full record on ClinicalTrials.gov
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