NCT06449209

Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy

A Phase II, Multi-site, Open-label, Parallel Group Trial of BNT327 in Combination With Chemotherapy for Participants With Untreated Extensive-stage Small-cell Lung Cancer and Participants With Previously Treated Small-cell Lung Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: BioNTech SE · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In Cohort 1 of this study, two dose levels of BNT327 will be studied in combination with etoposide and carboplatin to identify an optimized dose for future clinical investigation. Cohort 2 and Cohort 3 will explore the combination of two dose levels of BNT327 with paclitaxel, or topotecan in the second- or third-line setting. Patients will be treated until disease progression, intolerable toxicity, patient withdrawal, study termination or up to 2 years (whichever occurs first). Participants will be assigned to either Cohort 1 or Cohort 2/Cohort 3 based on their disease type (i.e., untreated ES-SCLC for Cohort 1 and SCLC which has progressed on first- or second-line treatment for Cohort 2 and Cohort 3). Assignment to either Cohort 2 or Cohort 3 will be the investigator's choice. Participants will be randomized to each arm within each cohort: * Participants enrolled to Cohort 1 and Cohort 3 will be randomized in a 1:1 ratio to Arm 1 or Arm 2. * Participants enrolled to Cohort 2 will be randomized in a 2:1 ratio to Arm 1 or Arm 2.

Conditions

• Extensive-stage Small-cell Lung Cancer
• Small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	BNT327 Dose Level 1 (DL1)	Intravenous (IV) infusion
DRUG	BNT327 Dose Level 2 (DL2)	IV infusion
DRUG	Etoposide	IV infusion
DRUG	Carboplatin	IV infusion
DRUG	Paclitaxel	IV infusion
DRUG	Topotecan	IV infusion or oral capsules

Timeline

• Start date: 2024-08-05
• Primary completion: 2027-06-01
• Completion: 2028-05-01
• First posted: 2024-06-07
• Last updated: 2026-04-17

Locations

64 sites across 5 countries: United States, Australia, South Korea, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study