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

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: BNT324 (biological), BNT327 (biological)
How long the study runs: Study runs about 84 months (dates as stated)
About the drug or intervention: BNT324 — biological: Intravenous infusion · BNT327 — biological: Intravenous infusion
Patient visit burden: Not specified by the sponsor

In plain English

This study tests a combination of two experimental medicines, BNT324 and BNT327, in adults with advanced lung cancer that cannot be removed by surgery. The researchers want to find out how well the combination works and how safe it is. The sponsor is BioNTech SE.

Who can take part

Adults aged 18 or over
Advanced or metastatic lung cancer that cannot be removed by surgery, confirmed by tissue or cell tests
Tumours that can be measured on scans (using a standard called RECIST version 1.1)
Able to carry out light activity (performance status of 0 or 1 on a scale used by doctors)
Expected to live at least 12 more weeks
People with non-small cell lung cancer (NSCLC) can join whatever their PD-L1 level is; those with certain gene changes (AGA-positive) must have had targeted treatment before joining
Different parts of the study include people with NSCLC or small cell lung cancer (SCLC), at different stages of treatment (first line or later)

Who may not be able to

Previous treatment aimed at B7-H3
Previous treatment with an antibody-drug conjugate (ADC) containing a topoisomerase inhibitor (for example datopotamab deruxtecan or trastuzumab deruxtecan) — this applies to people who have not yet had treatment for advanced disease; people already treated in this setting may still join
Someone whose cancer could be treated with surgery, targeted radiotherapy or tumour ablation with the aim of a cure, in the doctor's view
A history of serious blood-related side effects from earlier treatment, such as severe infection with very low white cell counts, as judged by the doctor
Other criteria may also apply depending on the study part — ask the trial team

What taking part involves

• Receiving the experimental combination of BNT324 and BNT327
• Not stated in detail — ask the trial team about how the medicines are given and what tests are involved

Time commitment: Not stated — ask the trial team about number of visits, how long the study lasts, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study: Testing a treatment
Ages: 18 Years and over
Who: All
Number of participants: 594
Started: 2025-05-02
Last checked: 2026-08

Plain English Summary

What is this study?

• Testing a new treatment for advanced lung cancer
• Phase1/Phase2 - 594 participants
• 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)

Who can take part?

• Ages 18 Years and over
• Diagnosed with advanced lung cancer

Where?

• Bristol - Bristol Haematology and Oncology Centre
• Leeds - St. James's University Hospital
• Liverpool - The Clatterbridge Cancer Center
• London - St George's Hospitals NHS Foundation Trust
• +3 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

More detail

This is a two-part study designed to evaluate and establish two safe combination dose levels (recommended Phase 2 dose \[RP2D\] and a lower/another combination dose level \[RP2D-1\]) of BNT324 with BNT327 (Part 1), to determine the optimal combination dose (dose optimization \[DO\]) in NSCLC and SCLC lead indication cohorts at the RP2D and RP2D-1, to evaluate the preliminary efficacy in selected lung cancer cohorts at the highest combination dose level (in a signal seeking Part 2), and to confirm the clinical efficacy of BNT324 in combination with BNT327 at the optimal dose level in participants with advanced lung cancer in expansion cohorts (proof-of-concept \[POC\] cohorts). The study consists of a screening period, a treatment period, a safety follow-up period, and a long-term survival follow-up period. In Part 1 participants with histologically or cytologically confirmed relapsed or progressive lung cancer (both SCLC and NSCLC are eligible) will receive BNT324 in combination with BNT327 using a dose escalation design. In Part 2 of the study, BNT324 will be studied in combination with BNT327 at the RP2D compared to RP2D-1 in participants with advanced metastatic treatment-naïve NSCLC (DO Cohort 1) and relapsed/progressive SCLC after failure of cytotoxic chemotherapy with or without immuno-oncology (IO) (DO Cohort 2). The totality of the available data (e.g., safety, efficacy, pharmacokinetics etc.) will be reviewed to select the optimal dose. After the optimal dose is selected, additional participants in each cohort may be enrolled in the selected optimal dose. In the signal seeking cohorts (Cohort 3-7), participants will receive BNT324 in combination with BNT327 at the RP2D from Part 1. A predefined number of participants in Part 2 Cohort 1 and Cohort 2 will be randomized to one of the two dose levels (RP2D and RP2D-1) selected from Part 1 in a 1:1 ratio. Additional participants in Part 2 Cohort 1 and Cohort 2 may be enrolled in the selected optimal dose to further assess the efficacy and safety profile. No randomization is planned for any other cohort in Part 2 or Part 1.

Advanced Lung Cancer

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 18 Years and over
Who can join: All genders

Biomarkers mentioned

PD-L1AGA negativeAGA positive

Treatment history

Treatments you must have had:

✓ received targeted therapy

What the study is looking for

✓Aged ≥18 years at the time of giving agreement to take part.
✓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+

Who cannot take part

✗Prior treatment with B7-H3 treatment that targets specific changes in the cancer.
✗Has a history of significant blood toxicity to previous treatments, as assessed by investigator, e.g.,...
✗NOTE: Other protocol defined Inclusion/Exclusion criteria may apply to all or some participants depending on the cohort.

See the full criteria

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

Where Is This Study? (7 UK sites)

Bristol Haematology and Oncology Centre

Bristol BS2 8ED, United Kingdom

Recruiting

St. James's University Hospital

Leeds LS97TF, United Kingdom

Recruiting