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.
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 (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
Where Is This Study? (18 UK sites)
The Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
Royal Marsden Hospital (RMH) - Royal Marsden NHS Foundation Trust
Chelsea SW3 6JJ, United Kingdom
Royal Marsden Hospital (Sutton) - Royal Marsden NHS Foundation Trust
Sutton SM2 5PT, United Kingdom
Huddersfield Royal Infirmary - Calderdale and Huddersfield NHS Foundation Trust
Huddersfield HD3 3EA, United Kingdom
Northern Centre for Cancer Care - The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne NE7 7DN, United Kingdom
Nottingham University Hospitals NHS Trust - Nottingham City Hospital
Nottingham NG5 1PB, United Kingdom
Churchill Hospital - Oxford University Hospitals NHS Foundation Trust
Oxford OX3 7LE, United Kingdom
Ninewells Hospital and Medical School - Tayside Health Board
Dundee DD1 9SY, United Kingdom
Torbay and South Devon NHS Foundation Trust
Torquay TQ2 7AA, United Kingdom
Royal Stoke University Hospital - University Hospitals of North Midlands NHS Trust
Stoke-on-Trent ST4 6QG, United Kingdom
Velindre NHS Trust, Velindre Cancer Centre
Cardiff CF14 2TL, United Kingdom
New Cross Hospital
Wolverhampton WV10 0QP, United Kingdom
Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust
Cambridge CB2 0QQ, United Kingdom
Hull University Teaching Hospitals NHS Trust
Cottingham HU16 5JQ, United Kingdom
James Illingworth
hyp-tr.development.research@nhs.net01482 461883 or 461903Royal Devon and Exeter Hospital, Royal Devon University Healthcare NHS Foundation Trust
Exeter EX2 5DW, United Kingdom
St James's University Hospital - Leeds Teaching Hospitals NHS Trust
Leeds LS9 7TF, United Kingdom
Guy's Hospital - Guy's & St Thomas' NHS Foundation Trust
London SE1 9RT, United Kingdom
Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust
Preston PR2 9HT, United Kingdom
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