Safety, Effectiveness, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer

Launched by BIONTECH SE · Nov 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BNT327, which is being tested in combination with standard chemotherapy and other experimental drugs for patients with non-small cell lung cancer (NSCLC). Specifically, the trial is looking at how safe and effective this new treatment is for patients who are in the later stages of NSCLC and who cannot undergo surgery or radiation. The trial is currently recruiting participants and is open to adults aged 65 to 74 with a confirmed diagnosis of Stage IIIB, IIIC, or Stage IV NSCLC, provided they have measurable cancer lesions and meet certain health criteria.

If you or a loved one is considering participating, you should know that participants will receive the new treatment and will be monitored closely for any side effects and how well the treatment works. To be eligible, individuals must not have received certain prior treatments, must have a good performance status (meaning they are generally well enough to participate), and must not have certain health conditions that could complicate treatment. This trial is an important step in finding better ways to treat lung cancer, and participants will contribute valuable information that could help future patients.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Have histologically or cytologically confirmed diagnosis of Stage IIIB or IIIC (who are not amenable to curative surgery or radiotherapy) or Stage IV NSCLC per the Union Internationale contre le Cancer/American Joint Committee on Cancer staging system, 8th edition without actionable epidermal growth factor receptor mutation or anaplastic lymphoma kinase (ALK) rearrangement.
• • Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures, etc.) are generally not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system metastasis should not be considered as a measurable lesion).
• • Eastern Cooperative Oncology Group performance status of 0 or 1.
• • Adequate organ function.
• Key Exclusion Criteria:
• • Have histologically or cytologically confirmed NSCLC with small-cell lung cancer histologic component.
• * Have received any of the following therapies or drugs within the noted time intervals prior to study treatment:
• • Participants who received prior treatment with anti-VEGF monoclonal antibody, or PD(L)-1/VEGF bispecific antibody or received platinum-based chemotherapy and/or anti-PD(L)-1 as part of adjuvant or neoadjuvant treatment
• • 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. 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. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing 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.
• • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.