Study on the Safety and Early Effectiveness of BNT327 with Chemotherapy for Advanced Non-Small Cell Lung Cancer

Sponsor: BioNTech SE

Sponsor score: 0

ClinicalTrials ID:NCT06841055

Provider View

This clinical trial is testing a new treatment, BNT327, combined with chemotherapy, for patients with advanced non-small cell lung cancer (NSCLC) that has worsened after initial chemoimmunotherapy. The study aims to determine if this combination is safe and effective.

Patient Parameters

Program Overview

This study is in Phase II and involves multiple locations. It is open-label, meaning both doctors and participants know what treatment is being given. The study has two parts. Part 1 focuses on testing the safety of BNT327 at two different doses combined with the chemotherapy drug docetaxel. Up to 12 participants will be involved in this part. Part 2 will expand the number of participants at the dose found to be safe in Part 1.

Description

In this study, if the dose of BNT327 from Part 1A or 1B is found to be tolerable, an internal review committee will decide if the study can move to Part 2, where more participants will be enrolled. Participants will receive BNT327 with docetaxel until their cancer progresses, they experience intolerable side effects, they choose to leave the study, they pass away, the study ends, or they reach a 2-year limit, whichever comes first. After finishing the study treatment, except for those who withdraw consent, participants will be followed up long-term to track cancer progression, any new cancer treatments, and survival status.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of Stage IV non-small cell lung cancer (NSCLC) that has worsened after one prior treatment with chemoimmunotherapy.
  • Must have received at least two cycles of immunotherapy in the first-line treatment.
  • Only one prior line of immunotherapy is allowed in the advanced/metastatic setting. If adjuvant immunotherapy was received, the disease-free period must be at least 6 months.
  • Historical PD-L1 test results must be available.
  • Patients with certain genetic changes can join if they received approved targeted therapy with immunotherapy in the first-line setting.
  • Enrollment of patients with primary resistance to prior treatment will be limited to 30% of the total study population.
  • Must have at least one measurable tumor lesion.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Must have adequate organ function.

Exclusion Criteria

  • Known allergy to the study treatments or their ingredients.
  • Have received prior treatment with certain antibodies or docetaxel alone or with other drugs.
  • Have had more than one prior treatment in the advanced/metastatic setting.
  • Have used high-dose corticosteroids within 14 days before starting the study treatment, except for certain short-term uses.
  • Have uncontrolled high blood pressure or poorly managed diabetes.
  • Have serious non-healing wounds or recent history of certain gastrointestinal issues.
  • Have major bleeding disorders or significant risk of bleeding.
  • Have superior vena cava syndrome or symptoms of spinal cord compression.

Locations

FACILITYZIPCITYSTATE
Millennium Research and Clinical Development, LLC77090HoustonTexas

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