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Investigational therapy for advanced non-small cell lung cancer combined with chemotherapy

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)

Phase 2 Interventional BioNTech SE · NCT06841055

This study is testing a new treatment that combines an experimental drug with chemotherapy to see if it helps people with advanced lung cancer who haven't responded to previous treatments.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment60 (estimated)
Ages18 Years and up
SexAll
SponsorBioNTech SE Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy, prednisone
Locations30 sites (Birmingham, Alabama and 29 other locations)
Trial IDNCT06841055 on ClinicalTrials.gov

What this trial studies

This Phase II, multisite, open-label study evaluates the safety and preliminary effectiveness of BNT327, an investigational bispecific antibody, in combination with docetaxel for patients with advanced non-small cell lung cancer (NSCLC) who have progressed after first-line chemoimmunotherapy. The study consists of two parts: a safety run-in with a small group of participants followed by a dose expansion if the treatment is deemed safe. Participants will receive the treatment until disease progression or intolerable toxicity occurs, with long-term follow-up to monitor outcomes. The study aims to assess the potential of this combination therapy to improve patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are patients with Stage IV NSCLC who have experienced disease progression after at least two cycles of first-line immunotherapy and have documented PD-L1 results.

Not a fit: Patients who have not received prior immunotherapy or those with earlier-stage NSCLC may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with advanced non-small cell lung cancer who have limited options after first-line treatment.

How similar studies have performed: Other studies have shown promise with similar combination therapies in advanced NSCLC, but this specific approach with BNT327 is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* 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.

Key Exclusion Criteria:

* 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.

NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

Where this trial is running

Birmingham, Alabama and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-small Cell Lung CancerSecond-line treatmentImmunotherapyCombination with other investigational agentsBispecific antibodyVascular endothelial growth factor AProgrammed death-ligand 1Combination with chemotherapy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.