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RecruitingPhase 1 / Phase 2NCT06892548
Official study title

A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer

Study summary

This study aims to investigate the combination of BNT324, a B7-H3 antibody-drug conjugate (ADC) with BNT327, a programmed death-ligand 1 (PD-L1) and vascular endothelial growth factor (VEGF) bispecific antibody, in participants with advanced/metastatic or relapsed/progressive small cell lung cancer (SCLC) and non small cell lung cancer (NSCLC).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedBNT324 and BNT327

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Small cell lung cancer (SCLC) · PD-L1

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 26, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?91 U.S. locations

Locations may change over time.

Who runs it?BioNTech SE

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
BioNTech SE
Interventions being studied
Biological: BNT324; Biological: BNT327
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→Small cell lung cancer (SCLC)→
Disease setting
Metastatic or stage IV→Recurrent or relapsed→
Biomarkers
PD-L1→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Aged ≥18 years at the time of giving informed consent.
  • Histological or cytological confirmed unresectable advanced/metastatic lung cancer. Histological classification may be based on tumor samples prior to metastatic disease. Participants with mixed histology must be classified based on the main component. Participants with NSCLC are eligible with any or no PD-L1 expression. Participants with AGA-positive disease must have received targeted therapy prior to enrollment in this study.
  • Part 1: Participants with NSCLC and SCLC
  • Part 2 Cohort 1: Participants with NSCLC (subpopulation 1) AGA negative, 1L
  • Part 2 Cohort 2: Participants with SCLC, 2L+
  • Part 2 Cohort 3: Participants with NSCLC (subpopulation 1) AGA negative, 2L+
  • Part 2 Cohort 4: Participants with NSCLC (subpopulation 2) AGA negative, 1L
  • Part 2 Cohort 5: Participants with NSCLC (subpopulation 2) AGA negative, 2L+
  • Part 2 Cohort 6: Participants with NSCLC AGA positive
  • Part 2 Cohort 7: Participants with SCLC, 1L
  • Have measurable disease defined by RECIST version 1.1.
  • Have an Eastern Cooperative Oncology Group performance status of 0 or 1.
  • Have a life expectancy of ≥12 weeks.
Reasons someone may not be able to joinExclusion criteria
  • Prior treatment with B7-H3 targeted therapy.
  • Prior treatment with ADC with topoisomerase inhibitor (e.g., datopotamab deruxtecan, trastuzumab deruxtecan). Note: This exclusion applies to participants in the first-line/treatment-naïve cohorts in the advanced/metastatic setting. Prior treatment with ADC with topoisomerase inhibitor payload is only allowed for participants in the second-line plus cohorts in the advanced/metastatic setting.
  • Is a candidate to locoregional treatment (including surgical resection, stereotactic radiotherapy or tumor ablation) with potential to induce complete or near complete response and prolonged tumor control (sometimes described as "radical" intent), per investigator's assessment.
  • Has a history of significant hematologic toxicity to prior lines of therapy, as assessed by investigator, e.g., Grade 4 febrile neutropenia or recurrent/persistent Grade 3 to 4 neutropenia. NOTE: Other protocol defined Inclusion/

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Mayo Clinic ArizonaPhoenix, Arizona
  • Precision NextGen Oncology and Research CenterBeverly Hills, California
  • Cedars Sinai Medical CenterLos Angeles, California
  • UCLA - David Geffen School of MedicineSanta Monica, California
  • University of Colorado Cancer CenterAurora, Colorado
  • Mayo Clinic in FloridaJacksonville, Florida
  • University of Iowa Hospitals & Clinics PARENTIowa City, Iowa
  • Mayo Clinic-RochesterRochester, Minnesota
  • Regional Cancer Care AssociatesBelleville, New Jersey
  • John Theurer Cancer Center at Hackensack UMCHackensack, New Jersey
  • Memorial Sloan Kettering Cancer Center (MSKCC)New York, New York
  • Icahn School of Medicine at Mount Sinai PRIMENew York, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 26, 2026. Always confirm current availability with the study team.

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