Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy
Running, not enrolling · Phase 2
Conditions studied: Extensive-stage Small-cell Lung Cancer, Small-cell Lung Cancer
In brief
This is a Phase II, multi-site, open-label, parallel group study in participants with untreated extended-stage small-cell lung cancer (ES-SCLC) (Cohort 1) or small-cell lung cancer (SCLC) which has progressed on first- or second-line treatment (Cohort 2 and Cohort 3). This study will assess the safety, efficacy, and pharmacokinetics (PK) of BNT327.
Key facts
- Study ID
- NCT06449209
- Run by
- BioNTech SE
- People needed
- 110
- Starts
- 2024-08-05
- Expected to finish
- 2028-05-01
- Last updated by the study team
- 2026-04-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Valkyrie Clinical Trials — Los Angeles, California, United States
- Clermont Oncology Center — Clermont, Florida, United States
- Hematology Oncology Associates of Treasure Coast — Port Saint Lucie, Florida, United States
- Tallahassee Memorial Physician Partners - Cancer & Hematology Specialists — Tallahassee, Florida, United States
- Carle Foundation Hospital d/b/a Carle Cancer Center — Urbana, Illinois, United States
- Fort Wayne Medical Oncology and Hematology, Inc — Fort Wayne, Indiana, United States
- University of Kentucky Chandler Medical Center (UKCMC) - Markey Cancer Center (Lucille P. Markey Cancer Center) — Lexington, Kentucky, United States
- Allina Health — Minneapolis, Minnesota, United States
- SSM Health Cancer Care - St. Clare — Fenton, Missouri, United States
- Nebraska Hematology-Oncology (NHO) - Lincoln — Lincoln, Nebraska, United States
- Clinical Research Alliance Inc — Westbury, New York, United States
- Haywood Infusion Center — Clyde, North Carolina, United States
- FirstHealth Outpatient Cancer Center — Pinehurst, North Carolina, United States
- The Christ Hospital Cancer Center — Cincinnati, Ohio, United States
- University of Tennessee Medical Center — Knoxville, Tennessee, United States
- Millenium Research & Clinical Development — Houston, Texas, United States
- SSM Health Cancer Care — Madison, Wisconsin, United States
- Lyell McEwin Hospital — Adelaide, Australia
- St. Vincent's Hospital — Fitzroy, Australia
- Peninsula Oncology Centre — Frankston, Australia
- Royal North Shore Hospital — St Leonards, Australia
- Westmead Hospital — Westmead, Australia
- Chungbuk National University Hospital — Cheongju-si, South Korea
- Yeungnam University Medical Center — Daegu, South Korea
- Alaska Oncology and Hematology, LLC — Anchorage, Alaska, United States
Full record on ClinicalTrials.gov
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