RecruitingPhase 2NCT06841055

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 II, Multisite, Open-label Trial of Pumitamig (BNT327) in Combination With Standard-of-care Chemotherapy in First-line and Second-line Non-small Cell Lung Cancer (NSCLC)

Sponsor

BioNTech SE

Enrollment

60 participants

Start Date

Mar 3, 2025

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the safety and early effectiveness of a drug called pumitamig (BNT327), a bispecific antibody that targets two proteins at once (PD-L1 and VEGF-A) to fight cancer. It's being tested in people with stage IV non-small cell lung cancer (NSCLC) that has stopped responding to first-line immunotherapy plus chemotherapy. **You may be eligible if...** - You have stage IV NSCLC confirmed by lab tests that has progressed after at least one prior line of treatment (a PD-1/PD-L1 immunotherapy plus platinum chemotherapy, at the same time) - You received at least 2 cycles of prior immunotherapy - You have measurable disease on scans - Your general health (ECOG) is 0 or 1 **You may NOT be eligible if...** - You have had more than one prior immunotherapy-containing regimen in the advanced setting - You have active brain metastases - You have serious autoimmune disease or are on immunosuppressants - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPumitamig

Intravenous infusion

DRUGDocetaxel

Intravenous infusion

Locations(30)

The University of Alabama at Birmingham Hospital

Birmingham, Alabama, United States

Moffitt Cancer Center

Tampa, Florida, United States

Baptist Health Hardin

Elizabethtown, Kentucky, United States

NYU Langone - NYU Grossman School of Medicine

New York, New York, United States

Texas Oncology, P.A.

Houston, Texas, United States

Liverpool Cancer Therapy Centre

Liverpool, New South Wales, Australia

Metro South Health - Princess Alexandra Hospital (PAH)

Woolloongabba, Queensland, Australia

Cancer Research SA (CRSA)

Adelaide, South Austraila, Australia

Hobart Hospital-Royal Hobart Hospital

Hobart, Tasmania, Australia

One Clinical Research - Hollywood Private Hospital

Nedlands, Western Australia, Australia

Gyeongsang National University Hospital (GNUH)

Jinju, Gyeongsangnam-do, South Korea

Chungbuk National University Hospital

Cheongju-si, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Institut dInvestigacio Biomedica de Bellvitge (IDIBELL)

Barcelona, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)

Valencia, Spain

Baskent University Adana Turgut Noyan Application and Research Center Kisla Health Campus

Adana, Turkey (Türkiye)

Memorial Ankara Hospital

Ankara, Turkey (Türkiye)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Memorial Antalya Hospital

Antalya, Turkey (Türkiye)

Yeditepe University Hospital

Istanbul, Turkey (Türkiye)

Koc Universitesi Hastanesi (Koc University Hospital)

Zeytinburnu, Turkey (Türkiye)

Velindre NHS Trust, Velindre Cancer Centre

Cardiff, United Kingdom

St James's University Hospital - Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Sarah Cannon Research Institute

London, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06841055

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