Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy
← catalyst calendarNCT06449209 · readout ≤ 315 d
Sponsored by BioNTech SE (industry) · BNTX — their whole pipeline →.
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
110estimated
Sites
64
Countries
Australia, South Korea, Turkey (Türkiye) +2
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 | 2024-08-05 | actual | When the study began enrolling |
| Primary completion | Jun 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | May 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2024-06-07 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-17 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Extensive-stage Small-cell Lung Cancer
- Small-cell Lung Cancer
Interventions
- Drug: BNT327 Dose Level 1 (DL1)
- Drug: BNT327 Dose Level 2 (DL2)
- Drug: Etoposide
- Drug: Carboplatin
- Drug: Paclitaxel
- Drug: Topotecan
Primary outcomes
what the primary-completion date above is the date OFOccurrence of treatment emergent adverse events (TEAEs), adverse events of special interest (AESIs), treatment-related TEAEs, treatment-related serious adverse events (SAEs) and treatment-related treatment emergent SAEs
measured up to 100 days after the last dose of treatment
Occurrence of dose interruption, reduction, and discontinuation of study treatment due to TEAEs
measured up to 100 days after the last dose of treatment
Objective Response Rate
measured up to 24 months after completion of study treatment of the last participant
Best percentage change from baseline in the tumor size
measured up to 24 months after completion of study treatment of the last participant
Proportion of participants who have achieved early tumor shrinkage
measured up to 2 months after first dose of treatment
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