Tests pumitamig with chemotherapy in people with advanced lung cancer
Tests pumitamig with docetaxel in adults with advanced non-small cell lung cancer.
Plain-language title generated from the registry record
Registry title: Safety and Preliminary Efficacy of Pumitamig (BNT327), an Investigational Therapy for Patients With Non-small Cell Lung Cancer in Combination With Chemotherapy as First-line or Second-line Treatment
Key facts
- Where
- Adelaide, Hobart, Liverpool, Nedlands, and Woolloongabba, AustraliaSee the 5 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with Stage IV non-small cell lung cancer that grew after one earlier treatment that combined immunotherapy and platinum chemotherapy. It tests pumitamig (BNT327) with docetaxel.
- Age
- 18 years and older
- Sex
- All sexes can join.
- Disease stage
- Stage IV non-small cell lung cancer (NSCLC), confirmed by tissue or cell tests. The cancer grew on or after one earlier line of treatment for advanced or spread disease. At least one lesion can be measured (RECIST v1.1). Performance status 0 or 1.
- Earlier treatment
- Must have had one earlier line of treatment: a PD-1/PD-L1 inhibitor given together with platinum-based chemotherapy, with at least two cycles of immunotherapy. Cannot have had more than one earlier line, anti-VEGF antibody, anti-PD-(L)-1/aVEGF bispecific antibody, or docetaxel.
- Biomarker or test result
- Earlier PD-L1 test results must be available. People with treatable gene changes can join if they had an approved targeted drug plus immunotherapy as first treatment. A tumor tissue sample taken within 18 months before joining is needed.
Main reasons for not taking part
- Known or suspected allergy to the study treatments or their ingredients, including polysorbate 80
- More than 10 mg/day of prednisone (or equivalent) steroids within 7 days before treatment starts
- Uncontrolled high blood pressure or poorly controlled diabetes within 7 days before the first dose
- Serious or non-healing wound, unhealed bone fracture, or fistula or gut perforation problems
- Superior vena cava syndrome, spinal cord compression symptoms, or significant risk of bleeding
Read by machine on 12 November 2026.
Where in Australia
- Cancer Research SA (CRSA)Adelaide, AustraliaTaking people
- Hobart Hospital-Royal Hobart HospitalHobart, AustraliaTaking people
- Liverpool Cancer Therapy CentreLiverpool, AustraliaTaking people
- One Clinical Research - Hollywood Private HospitalNedlands, AustraliaTaking people
- Metro South Health - Princess Alexandra Hospital (PAH)Woolloongabba, AustraliaTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- BioNTech SE
- Trial code
- NCT06841055EU 2024-518279-80-00
- Record updated
- 24 April 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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.
Exclusion: 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). 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; Have a known or suspected hypersensitivity to the study treatments, their metabolites or formulation of excipients including polysorbate 80 (see Docetaxel label); Participants with significant risk of hemorrhage as defined in the protocol; Have superior vena cava syndrome or symptoms of spinal cord compression; NOTE: Other protocol defined Inclusion/Exclusion criteria apply.