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

NCT06449209 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-04-17

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • BioNTech Responsible Person · BioNTech SE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-05
Primary Completion
2027-06-30
Completion
2028-05-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • South Korea
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06449209 on ClinicalTrials.gov