Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Pumitamig: Intravenous infusion
Pembrolizumab: Intravenous infusion
Carboplatin: Intravenous infusion
Pemetrexed: Intravenous infusion
Paclitaxel: Intravenous infusion
Study 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.
Eligibility
Primary outcome measure(s)
- Phase 2 - Occurrence of treatment-emergent adverse events (TEAE) (including Grade ≥3), adverse events of special interest (AESIs), treatment-related TEAEs, treatment-emergent serious adverse events (SAE), and treatment-related treatment emergent SAEs — From the first dose of the investigational medicinal product (IMP) to the 90-day Follow-Up Visit
For substudies A and B. AEs graded according to Common Terminology Criteria for Adverse Events (CTCAE v5.0) in the combination treatment regimen. - Phase 2 - Occurrence of dose interruption, reduction, and discontinuation of IMP due to TEAEs (including related TEAEs) — From the first dose of IMP to the 90-day Follow-Up Visit
For substudies A and B. - Phase 2 - Objective response rate (ORR) — Up to approximately 2 years
For substudies A and B. ORR is defined as the proportion of participants in whom a confirmed complete response (CR) or confirmed partial response (PR) (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\] based on the investigator's assessment) is observed as best overall response. - Phase 2 - Best percentage change from baseline in tumor size — Up to approximately 2 years
For substudies A and B. Based on investigator's tumor assessment according to RECIST v1.1. - Phase 3 - Progression free survival (PFS) assessed by BICR — Up to approximately 5 years
For substudies A and B. PFS defined as the time from randomization to first documented tumor progression (progressive disease per RECIST v1.1), or death from any cause, whichever occurs first.
Trial sites (365)
| Facility | City | Region | Status |
|---|---|---|---|
| Birmingham Hematology and Oncology Associates LLC d/b/a Alabama Oncology | Birmingham | Alabama | Recruiting |
| Alaska Oncology and Hematology, LLC | Anchorage | Alaska | Recruiting |
| John Muir Clinical Research Center | Concord | California | Recruiting |
| University Of California - San Diego Moores Cancer Center | La Jolla | California | Recruiting |
| Vail Health | Vail | Colorado | Recruiting |
| MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH) | Washington D.C. | District of Columbia | Recruiting |
| MEDSTAR Washington Hospital Center (MedStar Health Research Institute) | Washington D.C. | District of Columbia | Recruiting |
| Clermont Oncology Center | Clermont | Florida | Recruiting |
| SSAK Partners, LLC. | Coral Springs | Florida | Recruiting |
| Baptist Medical Center Jacksonville | Jacksonville | Florida | Recruiting |
| Mid Florida Cancer Centers | Orange City | Florida | Recruiting |
| Cleveland Clinic Florida - Martin North Hospital | Stuart | Florida | Recruiting |
| H. Lee Moffit Cancer center and research institute | Tampa | Florida | Recruiting |
| Cleveland Clinic Weston Hospital | Weston | Florida | Recruiting |
| Northwest Georgia Oncology Centers, P.C. | Marietta | Georgia | Recruiting |
| Fort Wayne Medical Oncology and Hematology, Inc. | Fort Wayne | Indiana | Recruiting |
| Indiana University Health University Hospital | Indianapolis | Indiana | Recruiting |
| Physicians Clinic of Iowa | Cedar Rapids | Iowa | Recruiting |
| Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics | Iowa City | Iowa | Recruiting |
| Baptist Health Hardin | Elizabethtown | Kentucky | Recruiting |
| Baptist Health Lexington | Lexington | Kentucky | Recruiting |
| University of Kentucky Chandler Medical Center (UKCMC) - Markey Cancer Center (Lucille P. Markey Cancer Center) | Lexington | Kentucky | Recruiting |
| Frederick Health Hospital- James M Stockman Cancer Institute | Frederick | Maryland | Recruiting |
| Missouri Cancer Associates | Columbia | Missouri | Recruiting |
| SSM Health Cancer Care - St. Clare | Fenton | Missouri | Recruiting |
| Mary Lanning Healthcare (MLH) - Morrison Cancer Center (MCC) | Hastings | Nebraska | Recruiting |
| Astera Cancer Care | East Brunswick | New Jersey | Recruiting |
| Summit Medical Group PA | Florham Park | New Jersey | Recruiting |
| The Valley Hospital - Valley Health System - The Robert and Audrey Luckow Pavilion | Paramus | New Jersey | Recruiting |
| Nuvance Health | Poughkeepsie | New York | Recruiting |
| Suny-Stony Brook University Cancer Center | Stony Brook | New York | Recruiting |
| White Plains Hospital | White Plains | New York | Recruiting |
| Fletcher Hospital, Inc. dba AdventHealth Hendersonville | Hendersonville | North Carolina | Recruiting |
| Gabrail Cancer Center Research | Canton | Ohio | Recruiting |
| The Christ Hospital Cancer Center | Cincinnati | Ohio | Recruiting |
| University of Cincinnati Medical Center | Cincinnati | Ohio | Recruiting |
| The Cleveland Clinic Cancer Center At Fairview Hospital, Moll Pavilion | Cleveland | Ohio | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | Recruiting |
| Dayton Physicians Network | Dayton | Ohio | Recruiting |
| Kettering Medical Center | Kettering | Ohio | Recruiting |
+ 325 more sites — see the full list on the official registry below.
On this site
📄 Keytruda (pembrolizumab) drug profile →More BioNTech SE trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06712316 on ClinicalTrials.gov ↗ ← All trials in Italy