Clinical Trial 23582

• Overview

  Study Title:

  A Phase II, multisite, open-label, single arm trial of BNT327 in combination with docetaxel in second-line stage IV non-small cell lung cancer (NSCLC) following chemoimmunotherapy

  Summary:

  This is a Phase II, multisite, open-label, single arm study with two parts in participants with advanced/metastatic NSCLC which progressed after a first-line chemoimmunotherapy. Part 1 is safety run-in with 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 BNT327 plus docetaxel.

  Objective:

  Primary Objectives *To assess the safety and tolerability of BNT327 in combination with docetaxel (Part 1 and overall) in the trial population (participants with advanced/metastatic NSCLC which progressed after a first-line chemoimmunotherapy). *To evaluate the efficacy of BNT327 with docetaxel in the trial population. Secondary Objectives *To evaluate other efficacy measures of BNT327 in combination with docetaxel in the trial population. *To characterize the PK of BNT327 after administration of BNT327 in combination with docetaxel in the trial population. *To evaluate the immunogenicity of BNT327 in combination with docetaxel in the trial population.

• Treatments

  Therapies:

  Chemotherapy (NOS); PD-L1/VEGF-A inhibitor

  Medications:

  BNT327 (); Taxotere (docetaxel); docetaxel ()

• Inclusion 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, 8th edition.
  • 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

  Key Exclusion Criteria:
  • Known 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 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.
  • Other protocol defined Inclusion/Exclusion criteria may apply.

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