Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Non-small Cell Lung Cancer in Combination With Chemotherapy Following Chemoimmunotherapy
NCT ID: NCT06841055
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2025-03-03
2028-10-31
Brief Summary
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Part 1 is safety run-in with pumitamig (BNT327) (Dose 1 or Dose 2) plus docetaxel and will include up to 12 participants to be treated in Part 1A and 1B sequentially.
Part 2 is a dose expansion at the deemed safe dose of pumitamig plus docetaxel.
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Detailed Description
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Study participants will receive pumitamig in combination with docetaxel until disease progression, the occurrence of intolerable toxicity, study participant withdrawal, death, study termination or 2-year limit (whichever comes first).
After completion of study treatment, except for participants who withdraw informed consent, a long-term follow-up will be conducted for all participants to record disease progression, subsequent new anticancer treatments, and survival status.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1A - Pumitamig Dose 1 + docetaxel
Pumitamig
Intravenous infusion
Docetaxel
Intravenous infusion
Part 1B - Pumitamig Dose 2 + docetaxel
Pumitamig
Intravenous infusion
Docetaxel
Intravenous infusion
Part 2 - Selected doses of pumitamig + docetaxel
Dose expansion at the deemed safe dose
Pumitamig
Intravenous infusion
Docetaxel
Intravenous infusion
Interventions
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Pumitamig
Intravenous infusion
Docetaxel
Intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants must have received minimum two cycles of immunotherapy in first-line treatment to be eligible to this trial.
* Only one prior line of immunotherapy containing regimen is allowed in advanced/metastatic setting. If participant had received adjuvant immunotherapy the disease-free interval (after the last dose of adjuvant immunotherapy) should be at least 6 months.
* Historical PD-L1 results must be available.
* Patients with actionable genetic alterations are allowed to be enrolled if patients received locally approved and available targeted agent in combination with immunotherapy in first-line advanced/metastatic setting.
* Enrollment of participants with primary resistance (best response being radiological progression to prior immunochemotherapy) will be capped under 30% in the overall trial population.
* Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been documented after irradiation. Historical images within 28 days of the Screening Visit may be accepted as a screening image if deemed acceptable in the opinion of the investigator.
* Eastern cooperative oncology group performance status of 0 or 1.
* Adequate organ function.
Exclusion Criteria
* Participants who received prior treatment with anti-vascular endothelial growth factor (VEGF) monoclonal antibody, or anti-PD-(L)-1/aVEGF bispecific antibody or docetaxel as monotherapy or in combination with other agents.
* Have received more than one prior lines of therapies in advanced/metastatic setting.
* Have received systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 14 days prior to the initiation of study treatment (except for docetaxel premedication). Note: local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short term use (≤7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens) are allowed.
* Have uncontrolled hypertension or poorly controlled diabetic conditions prior to study treatment.
* Have a serious non-healing wound, ulcer, or bone fracture. This includes history (within 6 months prior to study entry) or risk of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra abdominal abscess or esophageal and gastric varices, or acute gastrointestinal bleeding. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing the fistula/perforation.
* Participants with evidence of major coagulation disorders or other significant risks of hemorrhage.
* Have superior vena cava syndrome or symptoms of spinal cord compression
18 Years
ALL
No
Sponsors
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BioNTech SE
INDUSTRY
Responsible Party
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Principal Investigators
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BioNTech Responsible Person
Role: STUDY_DIRECTOR
BioNTech SE
Locations
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Moffitt Cancer Center
Tampa, Florida, United States
Baptist Health Hardin
Elizabethtown, Kentucky, United States
NYU Langone - NYU Grossman School of Medicine
New York, New York, United States
Texas Oncology, P.A.
Houston, Texas, United States
Cancer Research SA (CRSA)
Adelaide, South Austraila, Australia
One Clinical Research - Hollywood Private Hospital
Nedlands, Western Australia, Australia
Gyeongsang National University Hospital (GNUH)
Jinju, Gyeongsangnam-do, South Korea
Chungbuk National University Hospital
Cheongju-si, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
Valencia, , Spain
Baskent University Adana Turgut Noyan Application and Research Center Kisla Health Campus
Adana, , Turkey (Türkiye)
Memorial Ankara Hospital
Ankara, , Turkey (Türkiye)
Ankara Bilkent City Hospital
Ankara, , Turkey (Türkiye)
Memorial Antalya Hospital
Antalya, , Turkey (Türkiye)
Yeditepe University Hospital
Istanbul, , Turkey (Türkiye)
Velindre NHS Trust, Velindre Cancer Centre
Cardiff, , United Kingdom
St James's University Hospital - Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
Sarah Cannon Research Institute
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2024-518279-80-00
Identifier Type: CTIS
Identifier Source: secondary_id
BNT327-07
Identifier Type: -
Identifier Source: org_study_id
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