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Looking for participantsPhase2/Phase3

Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer

Sponsor: BioNTech SE

NCT ID: NCT06712316

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Pumitamig (drug), Pembrolizumab (drug), Carboplatin (drug), Pemetrexed (drug)
How long the study runs
Study runs about 83 months (dates as stated)
About the drug or intervention
Pumitamig — drug: Intravenous infusion · Pembrolizumab — drug: Intravenous infusion · Carboplatin — drug: Intravenous infusion · Pemetrexed — drug: Intravenous infusion · Paclitaxel — drug: Intravenous infusion
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
1,580
Started
2025-01-07
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for non-small cell lung cancer
  • • Phase2/Phase3 - 1,580 participants
  • • This is a Phase 2/3, multisite, randomized, open-label study in participants with first-line non-small cell lung cancer (NSCLC)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with non-small cell lung cancer

Where?

  • • Basildon - Basildon University Hospital - Basildon And Thurrock University Hospitals Nhs Foundation Trust
  • • Bath - Royal United Hospital, Bath - Royal United Hospitals Bath NHS Foundation Trust
  • • Brighton - Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust
  • • Cardiff - Velindre NHS Trust, Velindre Cancer Centre
  • • +15 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

Each substudy contains a Phase 2 part followed by a Phase 3 part. In the Phase 2 part, participants will be randomized to one of two dose levels of pumitamig (also known as BNT327, BMS-986545, or PM8002) plus chemotherapy (Arm 1 and Arm 2). In the Phase 3 part, participants will be randomized to pumitamig plus chemotherapy (Arm 3) or pembrolizumab plus chemotherapy (Arm 4). In China, additional participants will be enrolled into the Phase 2 part of each substudy to receive pumitamig plus chemotherapy (Arm 1A) to further evaluate the selected Phase 3 dose. For the Phase 3 part of both substudies, an independent data monitoring committee (IDMC) and a blinded Independent Central Review (BICR) will be established. The IDMC will provide independent review of the data during the study as needed and the BICR will review all available tumor assessment scans for all treated participants and will confirm the progression of disease, if applicable. The planned study duration per study participant is up to 64 months.

Non-small Cell Lung Cancer

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓activity scale Performance Status of 0 or 1.
  • ✓healthy organ as defined in the protocol.

Who cannot take part

  • ✗Have confirmed by testing a sample NSCLC with small-cell lung cancer or neuroendocrine histologic component.
  • ✗Have received any of the following therapies or drugs within the noted time intervals prior to study treatment:
  • ✗Previous drug treatment (platinum-based) or PD(L)-1 for treating NSCLC in either before surgery/after surgery or locally...
  • ✗Participants who received prior treatment with anti-VEGF monoclonal antibody, or PD(L)-1/VEGF bispecific antibody.
  • ✗Have uncontrolled hypertension or poorly controlled diabetic conditions prior to study treatment.
See the full criteria
Key Inclusion Criteria: * Have systemic treatment naive, histologically or cytologically confirmed diagnosis of Stage IIIB or IIIC (who are not amenable to curative surgery or radiotherapy) or Stage IV NSCLC per the Union Internationale contre le Cancer/American Joint Committee on Cancer staging system, 9th edition. * Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures, etc.) are generally not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system metastasis should not be considered as a measurable lesion). * Eastern Cooperative Oncology Group Performance Status of 0 or 1. * Adequate organ function as defined in the protocol. Key Exclusion Criteria: * Have histologically or cytologically confirmed NSCLC with small-cell lung cancer or neuroendocrine histologic component. * Have received any of the following therapies or drugs within the noted time intervals prior to study treatment: * Previous chemotherapy (platinum-based) or PD(L)-1 for treating NSCLC in either neoadjuvant/adjuvant or locally advanced/metastatic setting. * Participants who received prior treatment with anti-VEGF monoclonal antibody, or PD(L)-1/VEGF bispecific antibody. * Have received systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 7 days prior to the initiation of study treatment. Note: local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (\<=7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens) are allowed. * Have uncontrolled hypertension or poorly controlled diabetic conditions prior to study treatment. * Have a serious or non-healing wound, or (incompletely healed) bone fracture. This includes history (within 6 months prior to study entry) or risk of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess or esophageal and gastric varices. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing fistula/perforation. * Participants with significant risk of hemorrhage (per investigator clinical judgment). * Participants have superior vena cava syndrome or symptoms of spinal cord compression. NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

Where Is This Study? (19 UK sites)

Basildon University Hospital - Basildon And Thurrock University Hospitals Nhs Foundation Trust

Basildon SS16 5NL, United Kingdom

Recruiting

Royal United Hospital, Bath - Royal United Hospitals Bath NHS Foundation Trust

Bath BA1 3NG, United Kingdom

Recruiting
Hospital R&D contact (matched)

Amy Lloyd

ruh-tr.researchgovernance@nhs.net01225 821669

Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust

Brighton BN2 5BE, United Kingdom

Recruiting
Hospital R&D contact (matched)

Scott Harfield

uhsussex.research@nhs.net01273 696955 ext. 67497

Velindre NHS Trust, Velindre Cancer Centre

Cardiff CF14 2TL, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Townsend

Velindre.R&Doffice@wales.nhs.uk02920 196165

Royal Marsden Hospital (RMH) - Royal Marsden NHS Foundation Trust

Chelsea SW3 6JJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

Hull University Teaching Hospitals NHS Trust

Cottingham HU16 5JQ, United Kingdom

Recruiting
Hospital R&D contact (matched)

James Illingworth

hyp-tr.development.research@nhs.net01482 461883 or 461903

Beatson West of Scotland Cancer Centre - Greater Glasgow Health Board

Glasgow G12 0YN, United Kingdom

Recruiting
Hospital R&D contact (matched)

Jennifer McLean

jennifer.mclean@health.scot.nhs.uk0131 537 4718

Clatterbridge Cancer Centre

Liverpool L7 8YA, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Maria Maguire

maria.maguire2@nhs.net0151 556 5321

University College Hospital

London NW2 1PG, United Kingdom

Recruiting
Hospital R&D contact (matched)

Rajinder Sidhu - Associate Director, Research Governance and Operations

uclh.jro-communications@nhs.net020 3447 9825

Royal Marsden Hospital (Sutton) - Royal Marsden NHS Foundation Trust

London SM2 5PT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

The Christie NHS Foundation Trust

Manchester M20 4BX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net---

Norfolk and Norwich University Hospital - Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich NR4 7UY, United Kingdom

Recruiting
Hospital R&D contact (matched)

Julie Dawson

rdsubmissions@nnuh.nhs.uk01603 286611

Cancer And Haematology Centre-The Churchill Hospital-Oxford University Hospitals

Oxford OX3 7LJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Shahista Hussain

ouhtma@ouh.nhs.uk---

Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust

Preston PR2 9HT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Paul Brown

Research.Access@lthtr.nhs.uk01772 522031

Weston Park Hospital - Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield S10 2SJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alessia Dunn

STH.ResearchAdministration@nhs.net0114 2712550

Southampton General Hospital

Southampton SO16 6YD, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Mikayala King

researchmanagement@uhs.nhs.uk023 81208215

Musgrove Park Hospital-Taunton & Somerset NHS Foundation Trust

Taunton TA1 5DA, United Kingdom

Recruiting
Hospital R&D contact (matched)

Karen Tanner

Research@somersetft.nhs.uk01935 384559

New Cross Hospital

Wolverhampton WV10 0QP, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Glover

rwh-tr.rdpmteam@nhs.net01902 695065

York Teaching Hospital NHS Foundation Trust - The York Hospital

York YO31 8HE, United Kingdom

Recruiting
Hospital R&D contact (matched)

Lydia Harris

yhs-tr.research.governance@nhs.net01904 726606

How to Get in Touch

BioNTech clinical trials patient information

Sponsor contact

CONTACT

+49 6131 9084 patients@biontech.de
Data sourced from ClinicalTrials.gov · Last verified: 2026-09