Pumitamig with Chemotherapy for Non-small Cell Lung Cancer
This study is testing a new drug called pumitamig (also known as BNT327) in combination with chemotherapy (docetaxel) for people with advanced non-small cell lung cancer (NSCLC) that has progressed after prior treatment. The study aims to see how safe pumitamig is and if it shows early signs of working. You may be eligible if you have Stage IV NSCLC that has worsened after receiving a PD-1/PD-L1 inhibitor and platinum-based chemotherapy. The study will enroll up to 60 participants and is looking for how often side effects occur and how many people need to stop treatment due to side effects.
- Study design
- This is a Phase II, open-label study with two parts, enrolling up to 60 participants. Part 1 will test different doses of pumitamig with docetaxel in a small group, and Part 2 will expand to more participants at the safest dose.
- What's involved
- You will receive pumitamig and docetaxel until your disease progresses, you experience intolerable side effects, or for up to two years. Some participants in Part 2 will also need to provide additional tumor biopsies.
- Compensation
- Not stated in the trial record.
- Follow-up
- After treatment ends, you will be followed to record disease progression, new cancer treatments, and survival status.
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NCT06841055
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
Recruiting
PHASE2Ages 18+InterventionalTreatmentBioNTech SE
~60 participants
Updated 2026-04-24 on ClinicalTrials.gov
What's tested:PumitamigDocetaxel
At a glance
Recruiting sites
29 of 30 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1 - Occurrence of dose limiting toxicities (DLTs)
Measured over Up to 21 days after first dose of investigational medicinal product (IMP)
+3 more outcomes measured
Conditions
Where it's being run
30 sites across 15 statesTurkey (Türkiye)6
Spain5
South Korea4
United Kingdom4
Alabama1
Florida1
Kentucky1
New York1
Study leadership
- BioNTech Responsible Person · STUDY_DIRECTOR · BioNTech SE
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
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
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). 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.
What this trial measures
- Part 1 - Occurrence of dose limiting toxicities (DLTs)Up to 21 days after first dose of investigational medicinal product (IMP)
During the DLT evaluation period by dose level
- Part 1 and Part 2 - Occurrence of pumitamig treatment emergent adverse events, treatment-related adverse events, treatment emergent serious adverse events, treatment-related serious adverse events, and adverse events of special interestFrom initiation of the first dose of IMP to the 90-day Follow-Up visit
Graded according to the (United States) National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0)
- Part 1 and Part 2 - Occurrence of dose interruption, dose reduction, and/or participant discontinuation due to adverse eventsFrom initiation of the first dose of IMP until the 90-day Safety Follow-up visit
- Part 1 and Part 2 - Objective response rateUp to approximately 2 years
Defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) (per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) based on investigator's review) is observed as best overall response.