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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
Where Is This Study? (19 UK sites)
Basildon University Hospital - Basildon And Thurrock University Hospitals Nhs Foundation Trust
Basildon SS16 5NL, United Kingdom
Royal United Hospital, Bath - Royal United Hospitals Bath NHS Foundation Trust
Bath BA1 3NG, United Kingdom
Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust
Brighton BN2 5BE, United Kingdom
Velindre NHS Trust, Velindre Cancer Centre
Cardiff CF14 2TL, United Kingdom
Royal Marsden Hospital (RMH) - Royal Marsden NHS Foundation Trust
Chelsea SW3 6JJ, United Kingdom
Hull University Teaching Hospitals NHS Trust
Cottingham HU16 5JQ, United Kingdom
James Illingworth
hyp-tr.development.research@nhs.net01482 461883 or 461903Beatson West of Scotland Cancer Centre - Greater Glasgow Health Board
Glasgow G12 0YN, United Kingdom
Clatterbridge Cancer Centre
Liverpool L7 8YA, United Kingdom
University College Hospital
London NW2 1PG, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825Royal Marsden Hospital (Sutton) - Royal Marsden NHS Foundation Trust
London SM2 5PT, United Kingdom
The Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
Norfolk and Norwich University Hospital - Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich NR4 7UY, United Kingdom
Cancer And Haematology Centre-The Churchill Hospital-Oxford University Hospitals
Oxford OX3 7LJ, United Kingdom
Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust
Preston PR2 9HT, United Kingdom
Weston Park Hospital - Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield S10 2SJ, United Kingdom
Southampton General Hospital
Southampton SO16 6YD, United Kingdom
Musgrove Park Hospital-Taunton & Somerset NHS Foundation Trust
Taunton TA1 5DA, United Kingdom
New Cross Hospital
Wolverhampton WV10 0QP, United Kingdom
York Teaching Hospital NHS Foundation Trust - The York Hospital
York YO31 8HE, United Kingdom
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