Tests a two-drug combination in people with advanced lung cancer
Tests BNT324 with BNT327 in adults with advanced lung cancer.
Plain-language title generated from the registry record
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
Key facts
- Where
- Barcelona, Córdoba, Málaga, Sevilla, Torrejón de Ardoz, and Valencia, SpainSee the 8 sites
- Phase
- Phase 1/2
Where in Spain
- Hospital Clinic de BarcelonaBarcelona, SpainTaking people
- Hospital Universitari Dexeus Grupo QuironsaludBarcelona, SpainTaking people
- Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
- Hospital Universitario Reina SofiaCórdoba, SpainTaking people
- Hospital Quironsalud MalagaMálaga, SpainTaking people
- Hospital Universitario Virgen De ValmeSevilla, SpainTaking people
- Hospital Universitario de TorrejonTorrejón de Ardoz, SpainTaking people
- Hospital Universitario Y Politecnico La FeValencia, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- BioNTech SE
- Trial code
- NCT06892548EU 2024-520238-31-01
- Record updated
- 26 August 2026
- Original description
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).Read full original descriptionShow less
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
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).
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; NOTE: Other protocol defined Inclusion/Exclusion criteria may apply to all or some participants depending on the cohort.