Pumitamig Versus Durvalumab After Concurrent Chemoradiation in Unresectable Stage III Non-Small Cell Lung Cancer Without Progression

The primary objective is to compare pumitamig with durvalumab in participants with unresectable stage III non-small cell lung cancer without progression after platinum-based concurrent chemoradiation therapy, to determine which treatment more effectively delays disease worsening. This is clinically relevant for assessing disease control after definitive chemoradiation. The secondary objectives are to evaluate overall survival, safety, and tolerability of each medicine.

The study population comprised 571 patients with non-small cell lung cancer, including both female and male participants. The age range was not specified in the source data. Participants were selected from individuals with unresectable stage III disease whose cancer had not progressed after chemoradiation. Any level of PD-L1 expression was permitted, and overall health was required to be good. No information was provided on lifestyle considerations such as diet, physical activity, or habits.

This is a randomized, multicenter, open-label, phase 3 study comparing pumitamig monotherapy with durvalumab in participants with unresectable stage III non-small cell lung cancer without progression after platinum-based concurrent chemoradiation therapy. The trial is designed to assess whether pumitamig delays disease progression more effectively than durvalumab, with additional evaluation of overall survival, response outcomes, disease control, duration of response, time to response, and safety. The overall study period is estimated from 2026-05-11 to 2034-01-12. Participant involvement begins with a screening visit to confirm eligibility, including unresectable stage III disease without progression after chemoradiation, any level of PD-L1 expression, and adequate overall health. After randomization, treatment is administered and follow-up visits are performed to assess efficacy and safety outcomes over time. An end-of-study visit is conducted at the conclusion of participation to complete final assessments. The expected length of individual participation is not specified. Early termination may occur if eligibility criteria are not met, if disease progression is confirmed, or if treatment is not tolerated.

The experimental treatment consists of pumitamig, administered as a concentrate for solution for infusion by the intravenous route. Two presentation strengths are used in the study, BNT327 50 mg/ml and BNT327 20 mg/ml. The source data do not specify the administered dose or frequency.

The comparator treatment is durvalumab, administered by the intravenous route. The pharmaceutical form, dose, and frequency are not specified in the source data. The study is open-label and randomized, and treatment assignment is between pumitamig monotherapy and durvalumab.

No additional information on dosing schedules, administration procedures, or participant compliance monitoring is provided in the source data.

Efficacy will be assessed by comparing progression-free survival by blinded independent central review between pumitamig and durvalumab. Additional efficacy assessments will include overall survival, progression-free survival as judged by the investigator, objective response, disease control rate, duration of response, and time to response.

These endpoints will be used to evaluate delay in cancer progression, tumor shrinkage or disappearance, maintenance of tumor control, duration of tumor response, and time to initial response.