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Looking for participantsPhase3

Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer

Sponsor: BioNTech SE

NCT ID: NCT06712355

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), Atezolizumab (drug), Etoposide (drug), Carboplatin (or cisplatin if carboplatin is not tolerated) (drug)
How long the study runs
Study runs about 49 months (dates as stated)
About the drug or intervention
Pumitamig — drug: Intravenous infusion · Atezolizumab — drug: Intravenous infusion · Etoposide — drug: Intravenous infusion and capsules · Carboplatin (or cisplatin if carboplatin is not tolerated) — drug: Intravenous infusion
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at BNT327, an experimental (investigational) drug, given together with chemotherapy in people who have not yet had treatment for extensive-stage small-cell lung cancer (SCLC that has spread widely). The trial is funded by BioNTech SE. Its aim is to check how safe the combination is and how well it works.

Who can take part

  • Confirmed extensive-stage small-cell lung cancer, based on standard staging systems.
  • Have not had any whole-body (systemic) treatment for extensive-stage small-cell lung cancer before. People who had chemo-radiotherapy for earlier-stage disease may join if it was aimed at curing the disease and at least 6 months passed between that treatment and the new diagnosis.
  • Have at least one tumour that can be measured on scans (certain previously treated lesions, and single bone or brain spread, may not count).
  • Fully active or restricted only in strenuous activity (performance status 0 or 1).
  • Good enough blood counts and organ function, as set out in the trial protocol.

Who may not be able to

  • Small-cell lung cancer mixed with other types of lung cancer.
  • Recent certain treatments before joining: some small-molecule drugs or radiation outside the chest within 2 weeks; radiation to the chest, certain targeted drugs, antibodies or cell-based therapies within 4 weeks.
  • Previous treatment with anti-VEGF (blood-vessel targeting) antibody drugs or PD-1/PD-L1 and VEGF targeting bispecific antibodies.
  • Steroid tablets or injections above 10 mg prednisone-equivalent per day within 7 days of starting (some inhaled, local or short-course steroids are allowed).
  • Untreated brain spread that causes symptoms or is large (over 2 cm), or treated brain/central nervous system spread that is not stable or needs steroids; known spread to the membranes around the brain and spinal cord.
  • Uncontrolled high blood pressure or poorly controlled diabetes.
  • Serious or unhealed wounds or fractures, or past bowel perforation, fistula or abscess issues unless healed at least 6 months.
  • A significant risk of serious bleeding, in the judgement of the trial doctor.
  • Superior vena cava syndrome or spinal cord compression needing urgent treatment.
  • Other criteria in the trial protocol also apply — ask the trial team.

What taking part involves

  • • BNT327, an investigational (experimental) drug not yet approved, given together with chemotherapy.
  • • How it is given (for example, drip or injection), how often, and for how long: Not stated — ask the trial team.

Time commitment: Not stated — ask the trial team about the number of visits, tests, duration and what taking part would involve.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
621
Started
2025-02-03
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for extensive-stage small-cell lung cancer
  • • Phase3 - 621 participants
  • • This is a Phase III, multisite, randomized, double-blinded study to investigate pumitamig (BNT327) combined with chemotherapy (etoposide/carboplatin) compared to atezolizumab combined with chemotherapy (etoposide/carboplatin) for the treatment of participants with previously untreated extensive-stage small-cell lung cancer (ES-SCLC)

Who can take part?

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

Where?

  • • Manchester - The Christie NHS Foundation Trust
  • • Chelsea - Royal Marsden Hospital (RMH) - Royal Marsden NHS Foundation Trust
  • • Sutton - Royal Marsden Hospital (Sutton) - Royal Marsden NHS Foundation Trust
  • • Huddersfield - Huddersfield Royal Infirmary - Calderdale and Huddersfield NHS Foundation Trust
  • • +14 more UK sites

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

About This Trial

This is a Phase III, multisite, randomized, double-blinded study to investigate pumitamig (BNT327) combined with chemotherapy (etoposide/carboplatin) compared to atezolizumab combined with chemotherapy (etoposide/carboplatin) for the treatment of participants with previously untreated extensive-stage small-cell lung cancer (ES-SCLC).

More detail

There are two stages in this study: Stage 1 will have two treatment arms and one control arm, and Stage 2 will have a treatment arm and a control arm. The control arms in Stages 1 and 2 are the same. Each stage of the study consists of a screening period (up to 21 days), an induction period followed by a maintenance period (until confirmed disease progression, intolerable toxicity, participant withdrawal, study termination or up to 2 years \[whichever occurs first\]), and a follow-up (FU) period for all participants (2 safety FU visits and survival FU visits). In Stage 1, eligible participants will be randomized (1:1:1) to the arms. In Stage 2, participants will then be randomized (1:1) to the arms. The randomization will be stratified based on the following factors: 1. Brain or liver metastases per investigator assessment (presence versus absence); 2. Smoking status (smoker versus never-smoker); and 3. Geography. Participants will be allowed to switch to cisplatin if carboplatin is not tolerated at the investigator's discretion.

Extensive-stage Small-cell Lung Cancer

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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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 (ECOG) performance status of 0 or 1.
  • ✓Adequate blood and organ health as defined in the protocol.

Who cannot take part

  • ✗Have confirmed by testing a sample SCLC with combined histologies.
  • ✗Have received any of the following therapies or drugs within the noted time intervals prior to study treatment:
  • ✗Have received prior treatment with anti-vascular endothelial growth factor (VEGF) monoclonal antibody, or programmed...
  • ✗Have the following central nervous system metastases:
  • ✗Participants with untreated brain metastases that are causing symptoms or large (e.g., greater than 2 cm).
See the full criteria
Inclusion Criteria: * Have histologically or cytologically confirmed ES-SCLC (using the AJCC \[American Joint Committee on Cancer\] tumor node metastasis staging system combined with Veterans Administration Lung Study Group \[VALG\]'s two stage classification scheme). For AJCC tumor node metastasis staging system: AJCC 8th edition stage IV (T any, N any, M1a/b/c), or T3\~4 for multiple lung nodules or tumor/nodule volume that cannot be encompassed in a tolerable radiotherapy plan. * Have not had prior systemic therapy for ES-SCLC. However, participants with prior chemoradiotherapy for limited-stage-SCLC must have been treated with curative intent and had a treatment-free interval of at least 6 months after the last chemotherapy, radiotherapy, or chemoradiotherapy before diagnosis of ES-SCLC to be eligible. * 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 (ECOG) performance status of 0 or 1. * Adequate hematologic and organ function as defined in the protocol. Exclusion Criteria: * Have histologically or cytologically confirmed SCLC with combined histologies. * Have received any of the following therapies or drugs within the noted time intervals prior to study treatment: * Within 2 weeks: small molecule agents with half-life of \<7 days; radiation outside the thoracic cavity including whole brain radiation. Of note, other local radiation for brain lesions (not whole brain) is allowed; local radiation for bone lesions is allowed. Palliative bone radiation or brain stereotactic radiosurgery would not require a washout period, but participants should recover from radiotherapy-related toxicity. * Within 4 weeks: radiation involving the thoracic cavity; small molecule targeted agents with half-life of ≥7 days; monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or T-cell or other cell-based therapies. * Have received prior treatment with anti-vascular endothelial growth factor (VEGF) monoclonal antibody, or programmed death (ligand)-1 (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 the following central nervous system metastases: * Participants with untreated brain metastases that are symptomatic or large (e.g., greater than 2 cm). * Participants with treated central nervous system (CNS) metastases who are not neurologically stable or on steroids (at a dosage greater than 10 mg/Day of prednisone or an equivalent dose of other corticosteroid) within 7 days before initiating study treatment of this study. * Participants with known leptomeningeal metastases. * Have uncontrolled hypertension or poorly controlled diabetes prior to study treatment. * Have a serious or non-healing wound, or (incompletely healed) bone fracture. This includes history of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess for which an interval of 6 months must pass before study entry. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing the fistula/perforation. * Have a significant risk of hemorrhage (per investigator clinical judgment) as defined in the protocol. * Have superior vena cava syndrome or symptoms of spinal cord compression that requires urgent medical intervention. NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

Where Is This Study? (18 UK sites)

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---

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

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

Sutton SM2 5PT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

Huddersfield Royal Infirmary - Calderdale and Huddersfield NHS Foundation Trust

Huddersfield HD3 3EA, United Kingdom

Recruiting
Hospital R&D contact (matched)

Tracy Wood/Lesley Thomis

R&D@cht.nhs.uk01484 343396

Northern Centre for Cancer Care - The Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne NE7 7DN, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Development

nuth.genericqueries@nhs.net0191 282 4926

Nottingham University Hospitals NHS Trust - Nottingham City Hospital

Nottingham NG5 1PB, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alison Lloyd

nuhnt.researchsponsor@nhs.net0115 9249924

Churchill Hospital - Oxford University Hospitals NHS Foundation Trust

Oxford OX3 7LE, United Kingdom

Recruiting
Hospital R&D contact (matched)

Shahista Hussain

ouhtma@ouh.nhs.uk---

Ninewells Hospital and Medical School - Tayside Health Board

Dundee DD1 9SY, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mrs Liz Coote

Liz.Coote@nhs.scot01382 383876

Torbay and South Devon NHS Foundation Trust

Torquay TQ2 7AA, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Fiona Roberts (R&D Director)

tsdft.research@nhs.net01803 656635

Royal Stoke University Hospital - University Hospitals of North Midlands NHS Trust

Stoke-on-Trent ST4 6QG, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Jones

studysetup@uhnm.nhs.uk01782 675385

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

New Cross Hospital

Wolverhampton WV10 0QP, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Glover

rwh-tr.rdpmteam@nhs.net01902 695065

Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust

Cambridge CB2 0QQ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Stephen Kelleher

cuh.research@nhs.net01223 348490

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

Royal Devon and Exeter Hospital, Royal Devon University Healthcare NHS Foundation Trust

Exeter EX2 5DW, United Kingdom

Recruiting
Hospital R&D contact (matched)

Samantha Smart

rduh.research-eastern@nhs.net01392 406075

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

Leeds LS9 7TF, United Kingdom

Recruiting
Hospital R&D contact (matched)

R&I Team

leedsth-tr.researchfacilitation@nhs.net0113 2060469

Guy's Hospital - Guy's & St Thomas' NHS Foundation Trust

London SE1 9RT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Main Email: gstt.RandD@nhs.net

gstt.RandD@nhs.net---

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

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: 2026-08