A Phase III, multisite, double-blinded randomized trial of BNT327 in combination with chemotherapy (etoposide/carboplatin) compared to atezolizumab in combination with chemotherapy (etoposide/carboplatin) in participants with first-line extensive-stage small-cell lung cancer
Recipient organisationNIHR Nottingham Clinical Research Facility
NIHR supportRecorded as supported by this research centre
PeriodMar 2025 — Jun 2026
In plain English
AI plain-English summary
A new drug, BNT327, is being tested against the current standard treatment for extensive-stage small-cell lung cancer (ES-SCLC), a particularly aggressive form of the disease. This matters because ES-SCLC has a poor prognosis, and the current standard of care—the immunotherapy atezolizumab combined with chemotherapy—offers only modest survival benefits. The trial directly compares two different doses of BNT327 (1400mg and 2000mg) against atezolizumab, all given with chemotherapy, to see if the new drug improves outcomes. The study is double-blinded, so neither patients nor doctors know who receives which treatment, ensuring unbiased results. If BNT327 proves more effective, it could become a new first-line treatment option for patients with ES-SCLC, potentially extending survival or improving quality of life compared to the existing regimen. This would directly change clinical practice for a cancer with few effective therapies. The trial also determines the optimal dosage, which is critical for future use. Patients are followed until their disease worsens, they experience unacceptable side effects, or up to two years, with regular scans, blood tests, and health questionnaires tracking their response.
View original technical description
This study aims to understand the effects of BNT327 with chemotherapy, in treating extensive stage small cell lung cancer (EC-SCLC), compared to the current standard of care. The current standard of care for fit patients with ES-SCLC is a drug called atezolizumab, with chemotherapy. Patients can participate if they have ES-SCLC for which they have received no previous treatment, and if they are registered with a UK GP. If suitable, participants will be assigned to 1 of 3 groups: Group 1 will receive atezolizumab plus chemo therapy; Group 2 will receive the BNT327, at 2000mg, plus chemotherapy; Group 3 will receive BNT327, at 1400mg, plus chemotherapy. There are two different doses of BNT327 to understand which dosage is the "best" dosage. During the study, once the "best" dose has been determined (2000mg or 1400mg), participants in Group 2 and 3 will all be switched to the "best" dose. The study is double blinded meaning that the study team and the patient will not know whether they are receiving the study drug or the standard treatment. If needed for safety reasons, it can be found out immediately which drug and dosage the participant is on. Participants will receive the study drug or standard of care, plus chemotherapy in 4 cycles. Each cycle is 21 days. This is known as the Induction Period. Once the Induction Period is complete, participants will enter the Maintenance Period. During the Maintenance period, participants will receive the study drug or standard of care, without chemotherapy, on Day 1 of subsequent 21 day cycles. Participants will continue in the Maintenance until (whichever occurs first) the disease worsens, there are side effects which require participants to stop taking the study drug/standard of care, participants choose to withdraw from the study, if the study is stopped, or up to 2 years. During the study participants will be expected to provide information about their health through questionnaires, undergo scans and provide blood samples.
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