N
← Back to Search
Sponsored

Accelerate Your Clinical Trial Recruitment

Reach thousands of high-intent patients matching your specific inclusion criteria.

Start Campaign
RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: BioNTech SE • ClinicalTrials.gov ID: NCT06892548

Registry updated: 2026-08-26
Ad

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Check Eligibility →

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).

Interventions

  • BNT324 (Biological)
    Intravenous infusion
  • BNT327 (Biological)
    Intravenous infusion

Eligibility 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.

Conditions

Advanced Lung Cancer

Locations

  • Mayo Clinic Arizona — Phoenix, Arizona, United States
  • Precision NextGen Oncology and Research Center — Beverly Hills, California, United States
  • Cedars Sinai Medical Center — Los Angeles, California, United States
  • UCLA - David Geffen School of Medicine — Santa Monica, California, United States
  • University of Colorado Cancer Center — Aurora, Colorado, United States
  • Mayo Clinic in Florida — Jacksonville, Florida, United States
  • University of Iowa Hospitals & Clinics PARENT — Iowa City, Iowa, United States
  • Mayo Clinic-Rochester — Rochester, Minnesota, United States
  • Regional Cancer Care Associates — Belleville, New Jersey, United States
  • John Theurer Cancer Center at Hackensack UMC — Hackensack, New Jersey, United States
  • Memorial Sloan Kettering Cancer Center (MSKCC) — New York, New York, United States
  • Icahn School of Medicine at Mount Sinai PRIME — New York, New York, United States
  • Cleveland Clinic Taussig Cancer Institute Case Comprehensive Cancer Center — Cleveland, Ohio, United States
  • Texas Oncology - DFW — Dallas, Texas, United States
  • MD Anderson Cancer Center — Houston, Texas, United States
  • Texas Oncology - Northeast — Tyler, Texas, United States
  • Virginia Cancer Specialists — Fairfax, Virginia, United States
  • Chris O'Brien Lifehouse — Camperdown, New South Wales, Australia
  • Flinders Medical Centre — Bedford Park, South Australia, Australia
  • Bendigo Hospital — Bendigo, Victoria, Australia
  • Barwon Health — Geelong, Victoria, Australia
  • Sunshine Hospital — Saint Albans, Victoria, Australia
  • St John of God Subiaco Hospital — Subiaco, Western Australia, Australia
  • Anhui Provincial Cancer Hospital — Hefei, Anhui, China
  • Beijing Cancer Hospital — Beijing, Beijing Municipality, China
  • Beijing GoBroad Hospital — Beijing, Beijing Municipality, China
  • Fujian Medical University Union Hospital — Fuzhou, Fujian, China
  • Fujian Cancer Hospital — Fuzhou, Fujian, China
  • Guangxi Medical University Cancer Hospital — Nanning, Guangxi Zhuang, China
  • The First Affiliated Hospital of Xinxiang Medical University — Weihui, Henan, China
  • Henan Provincial Cancer Hospital — Zhengzhou, Henan, China
  • Jingzhou First People's Hospital — Jingzhou, Hubei, China
  • Xiangyang Central Hospital — Xiangyang, Hubei, China
  • Yichang Central People's Hospital — Yichang, Hubei, China
  • Hunan Province People's Hospital — Changsha, Hunan, China
  • Nanjing Chest Hospital — Nanjing, Jiangsu, China
  • The Second Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China
  • Jiangxi Cancer Hospital — Nanchang, Jiangxi, China
  • The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China
  • Jilin Cancer Hospital — Changchun, Jilin, China
  • Linyi Cancer Hospital — Shandong, Linyi, China
  • The First Affiliated Hospital of Xian Jiaotong University — Xi'an, Shaanxi, China
  • Jinan Central Hospital — Jinan, Shandong, China
  • Shandong Cancer Hospital — Jinan, Shandong, China
  • Shanghai GoBroad Cancer Hospital — Shanghai, Shanghai Municipality, China
  • West China Hospital, Sichuan University — Chengdu, Sichuan, China
  • First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China
  • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine — Hangzhou, Zhejiang, China
  • Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China
  • The First Affiliated Hospital of Xiamen University — Fujian, China
  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University — Guandong, China
  • Xuzhou Central Hospital — Xuzhou, China
  • Centre Hospitalier Intercommunal de Créteil — Créteil, France
  • Assistance Publique-Hôpitaux de Marseille — Marseille, France
  • Hôpital Foch — Suresnes, France
  • Hopital Larrey — Toulouse, France
  • IRCCS Istituto di Candiolo — Candiolo, Italy
  • IRCCS Ospedale San Raffaele — Milan, Italy
  • Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli" — Naples, Italy
  • Istituto Nazionale Tumori Regina Elena IRCCS — Roma, Italy
  • Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma) — Verona, Italy
  • Uniwersyteckie Centrum Kliniczne — Gdansk, Poland
  • Pratia Onkologia Katowice — Katowice, Poland
  • Centrum Medyczne Pratia Poznań — Poznan, Poland
  • Hospital Universitari Dexeus — Barcelona, Spain
  • Clinica Universidad de Navarra — Barcelona, Spain
  • Hospital Universitari Vall d'Hebron — Barcelona, Spain
  • Hospital Universitario Reina Sofia — Córdoba, Spain
  • Hospital Quironsalud Malaga — Málaga, Spain
  • Hospital Universitario Nuestra Señora de Valme — Seville, Spain
  • Hospital Universitario de Torrejón — Torrejón de Ardoz, Spain
  • Hospital Universitari i Politecnic La Fe — Valencia, Spain
  • Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan
  • Taichung Veterans General Hospital — Taichung, Taiwan
  • National Cheng Kung University Hospital — Tainan, Taiwan
  • National Taiwan University Cancer Center — Taipei, Taiwan
  • Taipei Veterans General Hospital — Taipei, Taiwan
  • Adana City Hospital — Adana, Turkey (Türkiye)
  • Hacettepe University Medical Faculty — Ankara, Turkey (Türkiye)
  • Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital — Ankara, Turkey (Türkiye)
  • Ankara City Hospital — Ankara, Turkey (Türkiye)
  • Yeditepe University Medical School Hospital — Istanbul, Turkey (Türkiye)
  • Koc University Hospital — Istanbul, Turkey (Türkiye)
  • Sakarya Training and Research Hospital — Sakarya, Turkey (Türkiye)
  • Bristol Haematology and Oncology Centre — Bristol, United Kingdom
  • St. James's University Hospital — Leeds, United Kingdom
  • The Clatterbridge Cancer Center — Liverpool, United Kingdom
  • St George's Hospitals NHS Foundation Trust — London, United Kingdom
  • University College London Hospital — London, United Kingdom
  • The Christie NHS Foundation Trust — Manchester, United Kingdom
  • Royal Preston Hospital — Preston, United Kingdom
Sponsored

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record