BNT327-06 - Ph2/3 study of BNT327 w/ chemo in NSCLC

• Research type

  Research Study

• Full title

  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

• IRAS ID

  1010867

• Contact name

  Clinical Trial Information Desk Clinical Trial Information Desk

• Contact email

  patients@biontech.de

• Sponsor organisation

  BioNTech SE

• Clinicaltrials.gov Identifier

  NCT06712316

• Research summary

  The purpose of this study is to evaluate the effects of two different doses (either 1400 mg or 2000 mg) of BNT327 (the “study drug”) when combined with chemotherapy (carboplatin with either pemetrexed OR with paclitaxel). This entire study consists of a Phase II study and a Phase III study. The primary purpose of the Phase II study is to determine the best dose for the Phase III part of this study. Phase III will not begin until after the Phase II study is completed because information from the Phase II study is needed before Phase III can begin.

  Participants will be assigned to either Sub-study A or B depending upon the type of diagnosed NSCLC:
  • Sub-study A is for participants that have non-squamous type non-small-cell lung cancer,
  • Sub-study B is for participants that have squamous type non-small-cell lung cancer.

  Within each sub-study, there are two dose groups. Participants will be randomly assigned to one of these two dose groups (treatment arms): BNT327 at 1400 mg or BNT327 at 2000 mg, plus the standard of care chemotherapy for the participants type of cancer.

  The maximum time participants might be in this study is for up to 64 months (about 5.3 years). This includes a Screening Period of up to 28 days, a Treatment Period of four 21-day cycles, and a Maintenance Period of continued 21-day cycles (both periods total up to 24 months / 2 years of treatment) and a Follow-up Period: including 30-Day and 90-Day Safety Follow-up Visits and a Survival Follow-up.

• REC name

  Wales REC 2

• REC reference

  24/WA/0341

• Date of REC Opinion

  20 Dec 2024

• REC opinion

  Further Information Favourable Opinion