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NCT06841055 · ClinicalTrials.gov registry record · Phase 2
Safety and Preliminary Efficacy of Pumitamig (BNT327), an Investigational Therapy for Patients With Non-small Cell Lung Cancer in Combination With Chemotherapy as First-line or Second-line Treatment
A Phase 2 study of Non-Small Cell Lung Cancer, sponsored by BioNTech SE.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 20
- Study locations
NCT06841055 is a Phase 2 study of Non-Small Cell Lung Cancer that is actively recruiting participants, run by BioNTech SE. The registered enrollment target is 60 participants, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 12 states.
The verdict
NCT06841055, a Phase 2 study of Non-Small Cell Lung Cancer, is actively recruiting participants, sponsored by BioNTech SE.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase II, multisite, open-label study consisting of two parts in participants with advanced/metastatic Non-small Cell Lung Cancer (NSCLC) which progressed after a first-line chemoimmunotherapy to evaluate the combination of pumitamig (also known as BNT327, BMS-986545 or PM8002) with standard of care. Part 1 is a safety run-in with pumitamig (Dose 1 or Dose 2) plus docetaxel and will include up to 12 participants in total to be treated in Part 1A and 1B sequentially. Part 2 is a dose expansion at the deemed safe dose of pumitamig plus docetaxel and will include up to 54 participants.
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG Pumitamig
Study Locations (20)
Other
- Chungbuk National University Hospital - Cheongju-si
- Gachon University Gil Medical Center - Incheon
- Severance Hospital, Yonsei University Health System - Seoul
- Samsung Medical Center - Seoul
- Institut dInvestigacio Biomedica de Bellvitge (IDIBELL) - Barcelona
- Hospital Universitario Ramón y Cajal - Madrid
- Hospital Universitario Fundacion Jimenez Diaz - Madrid
- Hospital Universitario Virgen del Rocio - Seville
- Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur) - Valencia
Alabama
- The University of Alabama at Birmingham Hospital - Birmingham
Florida
- Moffitt Cancer Center - Tampa
Kentucky
- Baptist Health Hardin - Elizabethtown
New York
- NYU Langone - NYU Grossman School of Medicine - New York
Texas
- Texas Oncology, P.A. - Houston
New South Wales
- Liverpool Cancer Therapy Centre - Liverpool
Queensland
- Metro South Health - Princess Alexandra Hospital (PAH) - Woolloongabba
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-03-03 |
| Est. Completion | 2028-10 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06841055
The ClinicalTrials.gov registry entry for NCT06841055 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (91% lower). The listed sponsor is BioNTech SE, which has 53 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Docetaxel is the first listed.
NCT06841055 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Other, Alabama, Florida.
Frequently Asked Questions
What is clinical trial NCT06841055 about?
NCT06841055 is a clinical study titled "Safety and Preliminary Efficacy of Pumitamig (BNT327), an Investigational Therapy for Patients With Non-small Cell Lung Cancer in Combination With Chemotherapy as First-line or Second-line Treatment". This is a Phase II, multisite, open-label study consisting of two parts in participants with advanced/metastatic Non-small Cell Lung Cancer (NSCLC) which progressed after a first-line chemoimmunotherapy to evaluate the combination of pumitamig (also known as BNT327, BMS-986545 or PM8002) with standa...
What is the current status of trial NCT06841055?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2025-03-03. Estimated completion is 2028-10.
What conditions does trial NCT06841055 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT06841055?
The interventions under investigation include: Docetaxel (DRUG), Pumitamig (DRUG).
Who is sponsoring clinical trial NCT06841055?
This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06841055 being conducted?
This trial has 20 study locations across Alabama, Florida, Kentucky, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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