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 Wellcome Trust Cambridge Clinical Research Facility
NIHR supportRecorded as supported by this research centre
PeriodFeb 2025 — Ongoing
In plain English
AI plain-English summary
A new clinical trial is testing whether an experimental drug, BNT327, can outperform the current standard treatment for people with 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 treatment options have improved little for decades. The current standard of care—a drug called atezolizumab combined with chemotherapy—extends survival but does not cure most patients. The trial directly compares two different doses of BNT327 plus chemotherapy against the standard regimen, in a double-blinded, randomised design across multiple UK sites. Patients who have not received prior treatment for their ES-SCLC are eligible to join. If BNT327 proves more effective or safer than atezolizumab, it could become a new first-line therapy for this patient group. The trial also aims to identify the optimal dose, which would streamline future treatment protocols. Beyond the immediate clinical impact, the results will inform whether this class of bispecific antibody can improve outcomes in a cancer type where progress has been slow. The study collects health questionnaires, scans, and blood samples, which may also yield insights into patient responses and biomarkers.
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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