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Taking people in TaiwanPhase 1/2

Tests a two-drug combination in people with advanced lung cancer

Tests BNT324 with BNT327 in adults with advanced lung cancer.

Key facts

Who runs it
BioNTech SE
Where
Kaohsiung City, Taichung, Tainan, and Taipei, TaiwanSee the 5 sitesAlso in 9 other countries, 88 sites
Trial code
Registry 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
Status
Recruiting
Phase
Phase 1/2
People taking part
594 people, planned
Started
2 May 2025
Expected to end
May 2032
Type of study
Interventional, 8 groups
Treatments tested
  • BNT324
  • BNT327
Record updated
26 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced or spread lung cancer, either small cell or non-small cell, that cannot be removed by surgery. It tests two drugs together, BNT324 and BNT327.

Age
18 years or older
Sex
All sexes can join
Disease stage
Lung cancer that cannot be removed by surgery and is advanced or has spread. It can be small cell (SCLC) or non-small cell (NSCLC). Some groups are for first treatment, others for second treatment or later. The disease must be measurable on scans (RECIST version 1.1).
Earlier treatment
People with a certain gene change (AGA-positive) must have already had targeted therapy. People joining the first-treatment groups cannot have had B7-H3 targeted therapy or an antibody-drug conjugate with a topoisomerase inhibitor. People in the later-treatment groups cannot have had B7-H3 targeted therapy.
Biomarker or test result
Non-small cell cancer can have any or no PD-L1 level. Some groups need no AGA gene change, and one group needs an AGA gene change.

Main reasons for not taking part

  • Earlier treatment with B7-H3 targeted therapy
  • Earlier treatment with an antibody-drug conjugate with a topoisomerase inhibitor (for first-treatment groups)
  • A doctor thinks local treatment such as surgery or radiotherapy could give a complete or near complete response
  • Serious blood problems with earlier treatments, such as grade 4 febrile neutropenia or repeated grade 3 to 4 neutropenia

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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/Exclusion criteria may apply to all or some participants depending on the cohort

Where in Taiwan

Also in 9 other countries, 88 sites

  • Kaohsiung Medical University Chung-Ho Memorial HospitalKaohsiung City, TaiwanTaking people
  • Taichung Veterans General HospitalTaichung, TaiwanTaking people
  • National Cheng Kung University HospitalTainan, TaiwanTaking people
  • National Taiwan University Cancer CenterTaipei, TaiwanTaking people
  • Taipei Veterans General HospitalTaipei, TaiwanTaking people

About the trial

What the trial wants to find out

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).

The 8 groups in the trial

  • Part 1 - BNT324 + BNT327 combination therapyTreatment being tested

    Escalating combination dose levels of BNT324 and BNT327 to define RP2D and RP2D-1 for NSCLC and SCLC.

    Treatment: BNT324 and BNT327

  • Part 2 - Cohort 1: RP2D of BNT324 + BNT327 and RP2D-1 of BNT324 + BNT327Treatment being tested

    In subpopulation 1 of NSCLC actionable oncogenic alteration (AGA) negative, first-line (1L)

    Treatment: BNT324 and BNT327

  • Part 2 - Cohort 2: RP2D of BNT324 + BNT327 and RP2D-1 of BNT324 + BNT327Treatment being tested

    In SCLC, second-line plus (2L+)

    Treatment: BNT324 and BNT327

  • Part 2 - Cohort 3: RP2D of BNT324 + BNT327Treatment being tested

    In subpopulation 1 of NSCLC AGA negative, 2L+

    Treatment: BNT324 and BNT327

  • Part 2 - Cohort 4: RP2D of BNT324 + BNT327Treatment being tested

    In subpopulation 2 of NSCLC AGA negative, 1L

    Treatment: BNT324 and BNT327

  • Part 2 - Cohort 5: RP2D of BNT324 + BNT327Treatment being tested

    In subpopulation 2 of NSCLC AGA negative, 2L+

    Treatment: BNT324 and BNT327

  • Part 2 - Cohort 6: RP2D of BNT324 + BNT327Treatment being tested

    In NSCLC AGA positive

    Treatment: BNT324 and BNT327

  • Part 2 - Cohort 7: RP2D of BNT324 + BNT327Treatment being tested

    In SCLC, 1L

    Treatment: BNT324 and BNT327

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase Ib/II, Multi-site, Open-label, Two-part Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Recommended Combination Dose of BNT324 With BNT327 in Participants With Advanced Lung Cancer
Plain-language title
Tests a two-drug combination in people with advanced lung cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
26 August 2026