What this study is
This is a Phase II, multisite, open-label study consisting of two parts in participants with advanced/metastatic Non-small Cell Lung Cancer (NSCLC) which progressed after a first-line chemoimmunotherapy to evaluate the combination of pumitamig (also known as BNT327, BMS-986545 or PM8002) with standard of care.
Part 1 is a safety run-in with pumitamig (Dose 1 or Dose 2) plus docetaxel and will include up to 12 participants in total to be treated in Part 1A and 1B sequentially.
Part 2 is a dose expansion at the deemed safe dose of pumitamig plus docetaxel and will include up to 54 participants.
What's being tested
- Pumitamig
Intervention · DRUG
- Docetaxel
Intervention · DRUG
Both interventions
Intravenous infusion
Study details
- Official title
- A Phase II, Multisite, Open-label Trial of Pumitamig (BNT327) in Combination With Standard-of-care Chemotherapy in First-line and Second-line Non-small Cell Lung Cancer (NSCLC)
- Sponsor
- BioNTech SE
- Conditions
- Non-small Cell Lung Cancer
- Enrolling
- 60 people
- Starts
- 2025-03-03
- Est. completion
- 2028-10
- Design
- Open-label, non-randomized, sequential groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Have histologically or cytologically confirmed diagnosis of Stage IV NSCLC that has documented radiographic progression on one or after one prior line of systemic treatment (programmed death-1 [PD-1]/ programmed death ligand-1 [PD-L1] inhibitor and platinum-based chemotherapy concomitantly) in advanced/metastatic setting per the American Joint Committee on Cancer staging system, 9th edition.; Participants must have received minimum two cycles of immunotherapy in first-line treatment to be eligible to this study.; Only one prior line of immunotherapy containing regimen is allowed in an 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.; Participants with actionable genetic alterations may be enrolled if they 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 kept below 30% in the overall study 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.
- Participants must provide tumor tissue samples obtained ≤18 months prior to enrollment. For the additional cohort in Part 2, both baseline (freshly obtained) and on-treatment tumor biopsy samples are required.
- Eastern cooperative oncology group performance status of 0 or 1.
- Adequate organ function as defined in the protocol.
You can't join if
- Have a known or suspected hypersensitivity to the study treatments, their metabolites or formulation of excipients including polysorbate 80 (see Docetaxel label).
- 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 7 days prior to the initiation of study treatment (except for docetaxel premedication)Except: 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.
- Participants who have received prior radiotherapy may be enrolled if they have no acute toxicity related to this therapy.
- Have uncontrolled hypertension or poorly controlled diabetic conditions within 7 days prior to the first dose of study treatment.
- Have a serious or non-healing wound, or (incompletely healed) 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 significant risk of hemorrhage as defined in the protocol.
- Have superior vena cava syndrome or symptoms of spinal cord compression.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (30)
29 openThe University of Alabama at Birmingham Hospital
Birmingham, Alabama, United States
RecruitingMoffitt Cancer Center
Tampa, Florida, United States
RecruitingBaptist Health Hardin
Elizabethtown, Kentucky, United States
RecruitingNYU Langone - NYU Grossman School of Medicine
New York, New York, United States
RecruitingTexas Oncology, P.A.
Houston, Texas, United States
Completed
25 sites outside the US
Liverpool Cancer Therapy Centre
Liverpool, New South Wales, Australia
RecruitingMetro South Health - Princess Alexandra Hospital (PAH)
Woolloongabba, Queensland, Australia
RecruitingCancer Research SA (CRSA)
Adelaide, South Austraila, Australia
RecruitingHobart Hospital-Royal Hobart Hospital
Hobart, Tasmania, Australia
RecruitingOne Clinical Research - Hollywood Private Hospital
Nedlands, Western Australia, Australia
RecruitingGyeongsang National University Hospital (GNUH)
Jinju, Gyeongsangnam-do, South Korea
RecruitingChungbuk National University Hospital
Cheongju-si, South Korea
RecruitingGachon University Gil Medical Center
Incheon, South Korea
RecruitingSeverance Hospital, Yonsei University Health System
Seoul, South Korea
RecruitingSamsung Medical Center
Seoul, South Korea
RecruitingInstitut dInvestigacio Biomedica de Bellvitge (IDIBELL)
Barcelona, Spain
RecruitingHospital Universitario Ramón y Cajal
Madrid, Spain
RecruitingHospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
RecruitingHospital Universitario Virgen del Rocio
Seville, Spain
RecruitingUniversitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
Valencia, Spain
RecruitingBaskent University Adana Turgut Noyan Application and Research Center Kisla Health Campus
Adana, Turkey (Türkiye)
RecruitingMemorial Ankara Hospital
Ankara, Turkey (Türkiye)
RecruitingAnkara Bilkent City Hospital
Ankara, Turkey (Türkiye)
RecruitingMemorial Antalya Hospital
Antalya, Turkey (Türkiye)
RecruitingYeditepe University Hospital
Istanbul, Turkey (Türkiye)
RecruitingKoc Universitesi Hastanesi (Koc University Hospital)
Zeytinburnu, Turkey (Türkiye)
RecruitingVelindre NHS Trust, Velindre Cancer Centre
Cardiff, United Kingdom
RecruitingSt James's University Hospital - Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
RecruitingSarah Cannon Research Institute
London, United Kingdom
RecruitingThe Christie NHS Foundation Trust
Manchester, United Kingdom
Recruiting
Study team
Sponsor
BioNTech SE
Study ID BNT327-07
Study director
BioNTech Responsible Person
BioNTech SE
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.