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RECRUITING 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

NCT06841055 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 60 participants
Start Date 2025-03-03
Est. Completion 2028-10
Phase Phase 2

Sponsor

BioNTech SE

123 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioNTech SE, which has 123 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06841055 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, Alabama, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06841055?

The interventions under investigation include: Docetaxel (DRUG), Pumitamig (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06841055?

This trial is sponsored by BioNTech SE, which has 123 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial