Back to search results

A Study of BNT324 and BNT327 for Advanced Lung Cancer

This study is testing a combination of two investigational medicines, BNT324 and BNT327, for people with advanced lung cancer. BNT324 is an antibody-drug conjugate (ADC), which is like a targeted chemotherapy that delivers medicine directly to cancer cells. BNT327 is a bispecific antibody that targets two proteins, PD-L1 and VEGF, which are involved in cancer growth and the immune system. The main goals are to find safe doses of these medicines together and to see how well they work in different types of advanced lung cancer. You may be able to join if you are 18 or older and have advanced lung cancer that has been confirmed by a doctor.

Study design
This is an interventional study with a planned enrollment of 594 participants. It has two parts: Part 1 focuses on finding safe dose levels, and Part 2 will evaluate how well the combination works.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety for up to 90 days after their last dose of study medicine or until new cancer treatment begins. There will also be a long-term survival follow-up period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06892548

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
BioNTech SE
~594 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:BNT324BNT327

At a glance

Recruiting sites
91 of 91 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1 - Occurrence of dose limiting toxicities (DLTs) by dose level
Measured over During the DLT evaluation period, i.e., the time of initiation of the first dose of investigational medicinal product (IMP) up to 21 days]
+6 more outcomes measured

Conditions

Advanced Lung Cancer

Explore related trials

Lung Non-Small Cell CarcinomaLung Small Cell Carcinoma

Where it's being run

91 sites across 39 states
Spain8
Turkey (Türkiye)7
United Kingdom7
Italy5
Taiwan5
France4
California3
Texas3

Study leadership

  • BioNTech Responsible Person · STUDY_DIRECTOR · BioNTech SE

Who to contact

BioNTech clinical trials patient information
[email protected]
+49 6131 9084 · ext. 0
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Part 1 - Occurrence of dose limiting toxicities (DLTs) by dose levelDuring the DLT evaluation period, i.e., the time of initiation of the first dose of investigational medicinal product (IMP) up to 21 days]
  • Part 1 - Occurrence of Treatment-emergent adverse events (TEAEs), serious TEAEs, treatment-related TEAEs, and treatment-related serious TEAEs by dose levelFrom the time of the first dose of IMP to 90 days after the last IMP dose or until new anticancer therapy is started, whichever occurs first
  • Part 1 - Occurrence of dose interruption, reduction, and treatment discontinuations due to TEAEs by dose levelFrom the time of the first dose of IMP to 90 days after the last dose of IMP or until new anticancer therapy is started, whichever occurs first
  • Part 2 cohorts 1 and 2 - Occurrence of TEAEs, serious TEAEs, treatment-related TEAEs, and treatment-related serious TEAEs by cohort and treatment armFrom the time of the first dose of IMP to 90 days after the last IMP dose or until new anticancer therapy is started, whichever occurs first
  • Part 2 cohorts 1 and 2 - Occurrence of dose interruption, reduction, and treatment discontinuation due to TEAEs by cohort and treatment armFrom the time of the first dose of IMP to 90 days after the last IMP dose or until new anticancer therapy is started, whichever occurs first
  • Part 2 cohorts 1 and 2 - Objective response rate (ORR) by cohort and treatment armFrom the time of initiation of the first dose of IMP to end of study, i.e., up to 87 months

    ORR defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) is observed as best overall response (per response evaluation criteria in solid tumors \[RECIST\] version 1.1 based on the investigator's assessment).

  • Part 2 cohorts 3-7 - ORR by cohortFrom the time of initiation of the first dose of IMP to end of study, i.e., up to 87 months

    ORR, defined as the proportion of participants in whom a confirmed CR or PR is observed as best overall response (per RECIST version 1.1 based on the investigator's assessment).