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

 A Phase II/III, Multisite, Randomized Master Protocol for a Global Trial of BNT327 in Combination With Chemotherapy and Other Investigational Agents in First-Line Non-Small Cell Lung Cancer

Objective

The purpose of this study is to evaluate the effects of two different doses of BNT327 (the study drug) when combined with chemotherapy (carboplatin with either paclitaxel or pemetrexed) to find out: best dose of BNT327, if the study drug can shrink cancer or prevent the cancer from getting worse, if the study drug is safe, tolerable and effective against this cancer, how the study drug is processed in the body, and how the study drug and cancer affect with participant's quality of life.

Eligibility

Key Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of Stage IIIB or IIIC (who are Criteria: not amenable to curative surgery or radiotherapy) 
  • Stage IV NSCLC 
  • Have minimum life expectancy of >3 months

Key Exclusion Criteria:

  • Participants with evidence of major coagulation disorders or other significant risks of hemorrhage

NCT ID

NCT06712316