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BNTXBioNTech SESigning up patients

A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer

Advanced Lung Cancer

0Calmworry score, out of 100

No strong warning signs right now. The score counts warning signs; it is not a prediction.

Why this score

No warning signs right now. That's why the score is 0.

Score over time

Stage
Phase 1/2
Patients
594 (planned)
Started
May 2, 2025
Main results expected
Sep 2028
Fully finished
May 2032
Results posted
not yet

What counts as success

The trial's main goal(s), called the “primary outcome.”

  • Part 1 - Occurrence of dose limiting toxicities (DLTs) by dose level

    Measured over: During the DLT evaluation period, i.e., the time of initiation of the first dose of investigational medicinal product (IMP) up to 21 days]

  • Part 1 - Occurrence of Treatment-emergent adverse events (TEAEs), serious TEAEs, treatment-related TEAEs, and treatment-related serious TEAEs by dose level

    Measured over: From the time of the first dose of IMP to 90 days after the last IMP dose or until new anticancer therapy is started, whichever occurs first

  • Part 1 - Occurrence of dose interruption, reduction, and treatment discontinuations due to TEAEs by dose level

    Measured over: From the time of the first dose of IMP to 90 days after the last dose of IMP or until new anticancer therapy is started, whichever occurs first

  • Part 2 cohorts 1 and 2 - Occurrence of TEAEs, serious TEAEs, treatment-related TEAEs, and treatment-related serious TEAEs by cohort and treatment arm

    Measured over: From the time of the first dose of IMP to 90 days after the last IMP dose or until new anticancer therapy is started, whichever occurs first

  • Part 2 cohorts 1 and 2 - Occurrence of dose interruption, reduction, and treatment discontinuation due to TEAEs by cohort and treatment arm

    Measured over: From the time of the first dose of IMP to 90 days after the last IMP dose or until new anticancer therapy is started, whichever occurs first

  • Part 2 cohorts 1 and 2 - Objective response rate (ORR) by cohort and treatment arm

    Measured over: From the time of initiation of the first dose of IMP to end of study, i.e., up to 87 months

  • Part 2 cohorts 3-7 - ORR by cohort

    Measured over: From the time of initiation of the first dose of IMP to end of study, i.e., up to 87 months

Changes Tremor has spotted

No changes since Tremor started watching this trial.
Show details (technical version)

Score inputs

  • none

Raw record changes

  • none yet

Trial ID NCT06892548 · record last updated 2026-08-26 · checked 2026-11-09 15:47 UTC

See the official record on ClinicalTrials.gov (NCT06892548) ↗