A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer
← catalyst calendarNCT06892548 · readout ≤ 773 d
Sponsored by BioNTech SE (industry) · BNTX — their whole pipeline →. With DualityBio Inc., Biotheus Inc..
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
594estimated
Sites
88
Countries
Australia, China, France +7
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-05-02 | actual | When the study began enrolling |
| Primary completion | Sep 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | May 2032 | estimated | The whole study's end, after follow-up |
| First posted | 2025-03-24 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-16 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Advanced Lung Cancer
Interventions
- Biological: BNT324 — also filed as DB-1311
- Biological: BNT327
Primary outcomes
what the primary-completion date above is the date OFPart 1 - Occurrence of dose limiting toxicities (DLTs) by dose level
measured During the DLT evaluation period, i.e., the time of initiation of the first dose of investigational medicinal product (IMP) up to 21 days]
Part 1 - Occurrence of Treatment-emergent adverse events (TEAEs), serious TEAEs, treatment-related TEAEs, and treatment-related serious TEAEs by dose level
measured From the time of the first dose of IMP to 90 days after the last IMP dose or until new anticancer therapy is started, whichever occurs first
Part 1 - Occurrence of dose interruption, reduction, and treatment discontinuations due to TEAEs by dose level
measured From the time of the first dose of IMP to 90 days after the last dose of IMP or until new anticancer therapy is started, whichever occurs first
Part 2 cohorts 1 and 2 - Occurrence of TEAEs, serious TEAEs, treatment-related TEAEs, and treatment-related serious TEAEs by cohort and treatment arm
measured From the time of the first dose of IMP to 90 days after the last IMP dose or until new anticancer therapy is started, whichever occurs first
Part 2 cohorts 1 and 2 - Occurrence of dose interruption, reduction, and treatment discontinuation due to TEAEs by cohort and treatment arm
measured From the time of the first dose of IMP to 90 days after the last IMP dose or until new anticancer therapy is started, whichever occurs first
Part 2 cohorts 1 and 2 - Objective response rate (ORR) by cohort and treatment arm
measured From the time of initiation of the first dose of IMP to end of study, i.e., up to 87 months
Part 2 cohorts 3-7 - ORR by cohort
measured From the time of initiation of the first dose of IMP to end of study, i.e., up to 87 months
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