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Life sciences · Phase 2 Trial
ClinicalTrials.gov · September 14, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
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Registry record from ClinicalTrials.gov (NCT06449209). This is a study registration, not published results. Lead sponsor: BioNTech SE. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 110 participants (ESTIMATED). 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 outcome measures: Occurrence 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 , up to 100 days after the last dose of treatment; Occurrence of dose interruption, reduction, and discontinuation of study treatment due to TEAEs , up to 100 days after the last dose of treatment; Objective Response Rate , until end-of-treatment visit, i.e., up to 24 months after the first dose of treatment; Best percentage change from baseline in the tumor size , Until end-of-treatment visit, i.e., up to 24 months after the first dose of treatment; Proportion of participants who have achieved early tumor shrinkage , up to 2 months after first dose of treatment. Brief summary: This is a Phase II, multi-site, open-label, parallel group study in participants with untreated extended-stage small-cell lung cancer (ES-SCLC) (Cohort 1) or small-cell lung cancer (SCLC) which has progressed on first- or second-line treatment (Cohort 2 and Cohort 3). This study will assess the safety, efficacy, and pharmacokinetics (PK) of BNT327.