Clinical trial • Phase I/II • Oncology
BNT327 for Advanced lung cancer|Non-small cell lung cancer|Small cell lung cancer
Phase I/II trial of BNT327 for Advanced lung cancer|Non-small cell lung cancer|Small cell lung cancer. Randomised, open-label, adaptive. 469 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced lung cancer|Non-small cell lung cancer|Small cell lung cancer
- Trial Stage
- Phase I/II
- Drug Modality
- Peptide/protein/enzyme
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 30-10-2025
- First CTIS Authorization Date
- 24-02-2026
Trial design
Randomised, open-label, adaptive Phase I/II trial across 26 sites in France, Italy, Poland and others.
- Randomised
- Yes
- Open Label
- Yes
- Adaptive
- True, includes Part 1 dose-escalation to determine RP2D with DLT evaluation and randomized dose-optimization cohorts in Part 2 (dose selection); specific interim analysis or stopping rules not specified in the provided data.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 469
Eligibility
Recruits 469 adults.
Inclusion criteria
- {"criterion_text":"- Aged ≥18 years at the time of giving informed consent.\n- 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.\n- Have measurable disease defined by RECIST version 1.1.\n- Have an Eastern Cooperative Oncology Group performance status of 0 or 1.\n- Have a life expectancy of ≥12 weeks."}
Exclusion criteria
- {"criterion_text":"- Prior treatment with B7-H3 targeted therapy.\n- 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.\n- 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.\n- 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."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Part 1 - Occurrence of dose limiting toxicities (DLTs) during the DLT evaluation period\n- Part 1 - Occurrence of Treatment-emergent adverse events (TEAEs), serious TEAEs, treatment-related TEAEs, and treatment-related serious TEAEs from 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\n- Part 1 - Occurrence of dose interruption, reduction, and treatment discontinuations due to TEAEs by dose level from 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\n- Part 2 cohorts 1 and 2 - Occurrence of TEAEs, serious TEAEs, treatment-related TEAEs, and treatment-related serious TEAEs from 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\n- Part 2 cohorts 1 and 2 - Occurrence of dose interruption, reduction, and treatment discontinuation due to TEAEs from 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\n- Part 2 cohorts 1 and 2 - Objective response rate (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 v1.1 based on the investigator’s assessment).\n- Part 2 cohorts 3-7 - ORR defined as the proportion of participants in whom a confirmed CR or PR is observed as best overall response (per RECIST version v1.1 based on the investigator’s assessment).","definition_or_measurement_approach":"- DLTs: occurrence during the DLT evaluation period (no additional definition provided in Part 1 primary endpoint text).\n- TEAEs/serious TEAEs/treatment-related TEAEs: counted from first dose of IMP to 90 days after last IMP dose or until new anticancer therapy is started, whichever occurs first.\n- Dose interruptions/reductions/discontinuations due to TEAEs: recorded by dose level from first dose to 90 days after last IMP dose or until new anticancer therapy is started.\n- ORR (Part 2 cohorts 1 and 2): defined as proportion with confirmed CR or PR as best overall response per RECIST v1.1 based on investigator’s assessment.\n- ORR (Part 2 cohorts 3-7): defined as proportion with confirmed CR or PR as best overall response per RECIST v1.1 based on investigator’s assessment."}
Secondary endpoints
- {"endpoint_text":"- Part 1 - ORR defined as the proportion of participants in whom a confirmed CR or PR is observed as best overall response (per RECIST version v1.1 based on the investigator’s assessment).\n- Part 1 - Disease control rate (DCR), defined as the proportion of participants with confirmed CR, PR, or stable disease (SD) as best overall response (per RECIST version v1.1 based on the investigator’s assessment).\n- Part 2 all cohorts - PFS defined as the time from first dose of IMP to the first objective tumor progression (PD) or death from any cause, whichever occurs first, per RECIST v1.1 based on the investigator’s assessment.\n- Part 2 all cohorts - Duration of response (DOR), defined as the time from first objective response (CR or PR) to first occurrence of objective tumor progression (PD) or death from any cause, whichever occurs first (per RECIST v1.1 based on the investigator’s assessment).\n- Part 2 all cohorts - Overall survival (OS), defined as the time from first dose of IMP to death from any cause.\n- Part 2 all cohorts - DCR, defined as the proportion of participants with confirmed CR, PR, or SD as best overall response (per RECIST v1.1 based on the investigator’s assessment).\n- Part 2 all cohorts - Time to response (TTR), defined as the time from first dose of IMP to first objective response (CR or PR per RECIST v1.1 based on the investigator’s assessment).\n- Part 2 cohorts 3-7 - Occurrence of TEAEs, serious TEAEs, treatment-related TEAEs, and treatment-related serious TEAEs from the time of the first dose of IMPs to 90 days after the last IMP dose or until new anticancer therapy is started, whichever occurs first.\n- Part 2 cohorts 3-7 - Occurrence of dose interruption, reduction, and treatment discontinuation due to TEAEs from 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.","definition_or_measurement_approach":"- ORR (Part 1): proportion with confirmed CR or PR per RECIST v1.1 (investigator assessment).\n- DCR (Part 1): proportion with confirmed CR, PR or SD per RECIST v1.1 (investigator assessment).\n- PFS (Part 2): time from first dose to objective progression or death per RECIST v1.1 (investigator assessment).\n- DOR (Part 2): time from first objective response to progression or death per RECIST v1.1 (investigator assessment).\n- OS (Part 2): time from first dose to death from any cause.\n- DCR (Part 2): proportion with confirmed CR, PR or SD per RECIST v1.1 (investigator assessment).\n- TTR (Part 2): time from first dose to first objective response (CR or PR) per RECIST v1.1 (investigator assessment).\n- TEAEs/serious TEAEs and dose interruptions/reductions/discontinuations in cohorts 3-7: captured from first dose to 90 days after last dose or until new anticancer therapy is started."}
Recruitment
- Planned Sample Size
- 469
- Recruitment Window Months
- 63
- Consent Approach
- Informed consent is required from participants aged ≥18 years at the time of giving informed consent. Subject information and informed consent forms (SIS and ICF) are available for publication with country-specific versions and languages (examples in the document list include V3.0FRA5.0, V3.0POL4.0, V3-0ESPes4, V3.0ITA3.0 and dedicated pregnancy and treatment-beyond-progression ICFs). Contact for trial information: Clinical Trial Information Desk (patients@biontech.de).
Geography
- Total Number Of Sites
- 26
- Total Number Of Participants
- 112
France
- Earliest CTIS Part Ii Submission Date
- 09-02-2026
- Latest Decision Or Authorization Date
- 07-05-2026
- Processing Time Days
- 87
- Number Of Sites
- 8
- Number Of Participants
- 26
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Medical Oncologist
- Principal Investigator Name
- Baptiste ABBAR
- Principal Investigator Email
- Baptiste.abbar@aphp.fr
- Contact Person Name
- Baptiste ABBAR
- Contact Person Email
- Baptiste.abbar@aphp.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Medical Oncologist
- Principal Investigator Name
- Sandrine HIRET
- Principal Investigator Email
- Sandrine.hiret@ico.unicancer.fr
- Contact Person Name
- Sandrine HIRET
- Contact Person Email
- Sandrine.hiret@ico.unicancer.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Medical Oncology
- Principal Investigator Name
- Judith RAIMBOURG
- Principal Investigator Email
- judith.raimbourg@ico.unicancer.fr
- Contact Person Name
- Judith RAIMBOURG
- Contact Person Email
- judith.raimbourg@ico.unicancer.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Medical Oncology
- Principal Investigator Name
- Aurore VOZY
- Principal Investigator Email
- aurore.vozy@aphp.fr
- Contact Person Name
- Aurore VOZY
- Contact Person Email
- aurore.vozy@aphp.fr
- Site Name
- Centre Hospitalier Intercommunal Creteil
- Department Name
- Pulmonology
- Principal Investigator Name
- Christos CHOUAID
- Principal Investigator Email
- christos.chouaid@chicreteil.fr
- Contact Person Name
- Christos CHOUAID
- Contact Person Email
- christos.chouaid@chicreteil.fr
- Site Name
- Hospital Foch
- Department Name
- Medical Oncology
- Principal Investigator Name
- Jaafar BENNOUNA
- Principal Investigator Email
- j.bennouna@hopital-foch.com
- Contact Person Name
- Jaafar BENNOUNA
- Contact Person Email
- j.bennouna@hopital-foch.com
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Pneumology
- Principal Investigator Name
- Julien MAZIERES
- Principal Investigator Email
- mazieres.j@chu-toulouse.fr
- Contact Person Name
- Julien MAZIERES
- Contact Person Email
- mazieres.j@chu-toulouse.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Oncology
- Principal Investigator Name
- Laurent GREILLIER
- Principal Investigator Email
- Laurent.GREILLIER@ap-hm.fr
- Contact Person Name
- Laurent GREILLIER
- Contact Person Email
- Laurent.GREILLIER@ap-hm.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 12-02-2026
- Latest Decision Or Authorization Date
- 10-03-2026
- Processing Time Days
- 26
- Number Of Sites
- 5
- Number Of Participants
- 30
Sites
- Site Name
- Centro Ricerche Cliniche Di Verona S.r.l.
- Department Name
- Oncology
- Principal Investigator Name
- Sara Pilotto
- Principal Investigator Email
- sara.pilotto@univr.it
- Contact Person Name
- Sara Pilotto
- Contact Person Email
- sara.pilotto@univr.it
- Site Name
- I.F.O. Istituti Fisioterapici Ospitalieri
- Department Name
- Medical Oncology 2
- Principal Investigator Name
- Federico Cappuzzo
- Principal Investigator Email
- federico.cappuzzo@ifo.it
- Contact Person Name
- Federico Cappuzzo
- Contact Person Email
- federico.cappuzzo@ifo.it
- Site Name
- Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
- Department Name
- Medical Oncology
- Principal Investigator Name
- Chiara Lazzari
- Principal Investigator Email
- chiara.lazzari@ircc.it
- Contact Person Name
- Chiara Lazzari
- Contact Person Email
- chiara.lazzari@ircc.it
- Site Name
- Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
- Department Name
- Oncology
- Principal Investigator Name
- Floriana Morgillo
- Principal Investigator Email
- floriana.morgillo@unicampania.it
- Contact Person Name
- Floriana Morgillo
- Contact Person Email
- floriana.morgillo@unicampania.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Medical Oncology
- Principal Investigator Name
- Alessandra Bulotta
- Principal Investigator Email
- bulotta.alessandra@hsr.it
- Contact Person Name
- Alessandra Bulotta
- Contact Person Email
- bulotta.alessandra@hsr.it
Poland
- Earliest CTIS Part Ii Submission Date
- 06-02-2026
- Latest Decision Or Authorization Date
- 13-03-2026
- Processing Time Days
- 35
- Number Of Sites
- 5
- Number Of Participants
- 30
Sites
- Site Name
- Pratia S.A.
- Department Name
- Pratia MCM Krakow
- Principal Investigator Name
- Anna Drosik-Kwasniewska
- Principal Investigator Email
- adrosik-kwasniewska@pratia.pl
- Contact Person Name
- Anna Drosik-Kwasniewska
- Contact Person Email
- adrosik-kwasniewska@pratia.pl
- Site Name
- Pratia S.A.
- Department Name
- Pratia Poznań
- Principal Investigator Name
- Marek Kotlarski
- Principal Investigator Email
- marek.kotlarski@pratia.com
- Contact Person Name
- Marek Kotlarski
- Contact Person Email
- marek.kotlarski@pratia.com
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Centrum Wsparcia Badań Klinicznych UCK Ośrodek Badań Klinicznych Wczesnych Faz
- Principal Investigator Name
- Rafał Dziadziuszko
- Principal Investigator Email
- rafald@gumed.edu.pl
- Contact Person Name
- Rafał Dziadziuszko
- Contact Person Email
- rafald@gumed.edu.pl
- Site Name
- Pratia Hematologia Sp. z o.o.
- Department Name
- Pratia Onkologia Katowice
- Principal Investigator Name
- Agata Kachel-Flis
- Principal Investigator Email
- agata.kachel-flis@pratia.com
- Contact Person Name
- Agata Kachel-Flis
- Contact Person Email
- agata.kachel-flis@pratia.com
- Site Name
- Zanamed Medical Clinic Sp. z o.o.
- Department Name
- Zanamed Medical Clinic
- Principal Investigator Name
- Ludmiła Grzybowska-Szatkowska
- Principal Investigator Email
- ludmila.szatkowska@zanamed.pl
- Contact Person Name
- Ludmiła Grzybowska-Szatkowska
- Contact Person Email
- ludmila.szatkowska@zanamed.pl
Spain
- Earliest CTIS Part Ii Submission Date
- 05-12-2025
- Latest Decision Or Authorization Date
- 02-03-2026
- Processing Time Days
- 87
- Number Of Sites
- 8
- Number Of Participants
- 26
Sites
- Site Name
- Hospital Universitario De Torrejon
- Department Name
- Oncologia
- Principal Investigator Name
- Luis Cabezon Gutierrez
- Principal Investigator Email
- lcabezon@torrejonsalud.com
- Contact Person Name
- Luis Cabezon Gutierrez
- Contact Person Email
- lcabezon@torrejonsalud.com
- Site Name
- Hospital Quironsalud Malaga
- Department Name
- Oncologia
- Principal Investigator Name
- Manuel Cobo Dols
- Principal Investigator Email
- manuel.cobo.co@quironsalud.es
- Contact Person Name
- Manuel Cobo Dols
- Contact Person Email
- manuel.cobo.co@quironsalud.es
- Site Name
- Hospital Universitari Dexeus Grupo Quironsalud
- Department Name
- Oncologia
- Principal Investigator Name
- Andres Aguilar Hernandez
- Principal Investigator Email
- aaguilar@oncorosell.com
- Contact Person Name
- Andres Aguilar Hernandez
- Contact Person Email
- aaguilar@oncorosell.com
- Site Name
- Hospital Universitario Reina Sofia
- Department Name
- Oncologia
- Principal Investigator Name
- Isidoro Carlos Barneto Aranda
- Principal Investigator Email
- isidoroc.barneto.sspa@juntadeandalucia.es
- Contact Person Name
- Isidoro Carlos Barneto Aranda
- Contact Person Email
- isidoroc.barneto.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitario Virgen De Valme
- Department Name
- Oncologia
- Principal Investigator Name
- Jose Fuentes Pradera
- Principal Investigator Email
- fuentespradera@hotmail.com
- Contact Person Name
- Jose Fuentes Pradera
- Contact Person Email
- fuentespradera@hotmail.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Oncologia
- Principal Investigator Name
- Noemi Reguart
- Principal Investigator Email
- BNEGUART@clinic.cat
- Contact Person Name
- Noemi Reguart
- Contact Person Email
- BNEGUART@clinic.cat
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncologia
- Principal Investigator Name
- Enriqueta Felip Font
- Principal Investigator Email
- efelip@vhio.net
- Contact Person Name
- Enriqueta Felip Font
- Contact Person Email
- efelip@vhio.net
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Oncologia
- Principal Investigator Name
- Oscar Jose Juan Vidal
- Principal Investigator Email
- juan_osc@gva.es
- Contact Person Name
- Oscar Jose Juan Vidal
- Contact Person Email
- juan_osc@gva.es
Sponsor
Primary sponsor
- Full Name
- BioNTech SE
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Contract research organisations
- Name
- Endpoint Clinical Inc.
- Responsibilities
- [{"code":"3"}]
- Name
- Almac Clinical Services Limited
- Responsibilities
- [{"code":"14"}]
- Name
- IQVIA Limited
- Responsibilities
- [{"code":"11"},{"code":"12"},{"code":"13"},{"code":"15","value":"ECG services and ECG machines, where required"},{"code":"2"},{"code":"5"},{"code":"6"},{"code":"7"},{"code":"8"}]
Third parties
- {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"[{\"code\":\"3\"}]","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"[{\"code\":\"14\"}]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"[{\"code\":\"15\",\"value\":\"Imaging and ILD adjudication\"}]","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"[{\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Foundation Medicine Inc.","duties_or_roles":"[{\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"[{\"code\":\"15\",\"value\":\"ancillaries and equipment supply\"}]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"[{\"code\":\"15\",\"value\":\"patient concierge provider\"}]","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"[{\"code\":\"11\"},{\"code\":\"12\"},{\"code\":\"13\"},{\"code\":\"15\",\"value\":\"ECG services and ECG machines, where required\"},{\"code\":\"2\"},{\"code\":\"5\"},{\"code\":\"6\"},{\"code\":\"7\"},{\"code\":\"8\"}]","organisation_type":"Pharmaceutical company"}
- {"country":"Singapore","full_name":"Labcorp Development (Asia) Pte Ltd","duties_or_roles":"[{\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"BioAgilytix Europe GmbH","duties_or_roles":"[{\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"[{\"code\":\"7\"}]","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- BNT327
- Active Substance
- BNT327
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- prodAuthStatus: 1
- Orphan Designation
- Yes
- Investigational Product Name
- BNT324
- Active Substance
- BNT324
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- prodAuthStatus: 1
- Orphan Designation
- Yes
- Combination Treatment
- Yes
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