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Study details
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A Clinical Trial to Investigate a New Treatment for Advanced Lung Cancer

BioNTech SE
NCT IDNCT06892548ClinicalTrials.gov data as of Apr 2026
Phase

Phase 1/2

Target enrollment

594

Study length

about 6.2 years

Ages

18+

Locations

15 sites in AZ, CA, FL +7

What this study is about

This trial is testing the safety and effectiveness of a new combination treatment with BNT324 and BNT327 in people with advanced lung cancer. The treatment involves taking medication, and it will last about 2 years.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Receive BNT324
  • 2.Receive BNT327

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
Standard

How treatment is administered

Treatment Assignment
Randomized (Open Label)

You are randomly assigned, but you will know your treatment.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Endpoints

Primary: Part 1 - Occurrence of Treatment-emergent adverse events (TEAEs), serious TEAEs, treatment-related TEAEs, and treatment-related serious TEAEs by dose level, Part 1 - Occurrence of dose interruption, reduction, and treatment discontinuations due to TEAEs by dose level, Part 2 cohorts 1 and 2 - Objective response rate (ORR) by cohort and treatment arm, Part 2 cohorts 1 and 2 - Occurrence of TEAEs, serious TEAEs, treatment-related TEAEs, and treatment-related serious TEAEs by cohort and treatment arm, Part 2 cohorts 1 and 2 - Occurrence of dose interruption, reduction, and treatment discontinuation due to TEAEs by cohort and treatment arm, Part 2 cohorts 3-7 - ORR by cohort

Secondary: Part 1 - Disease control rate (DCR) by dose level, Part 1 - ORR by dose level, Part 2 all cohorts - (PFS) by cohort and treatment arm, Part 2 all cohorts - DCR by cohort and treatment arm, Part 2 all cohorts - Duration of response (DOR) by cohort and treatment arm, Part 2 all cohorts - Overall survival (OS) by cohort and treatment arm, Part 2 cohorts 3-7 - Occurrence of TEAEs, serious TEAEs, treatment-related TEAEs, and treatment-related serious TEAEs by cohort and treatment arm, Part 2 cohorts 3-7 - Occurrence of dose interruption, reduction, and treatment discontinuation due to TEAEs by cohort and treatment arm

Body systems

Oncology