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BNTXBioNTech SESigning up patients

Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer (ROSETTA Lung-02)

Non-small Cell 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 2/3
Patients
1,580 (planned)
Started
Jan 7, 2025
Main results expected
Jan 2029
Fully finished
Dec 2031
Results posted
not yet

What counts as success

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

  • Phase 2 - Occurrence of treatment-emergent adverse events (TEAE) (including Grade ≥3), adverse events of special interest (AESIs), treatment-related TEAEs, treatment-emergent serious adverse events (SAE), and treatment-related treatment emergent SAEs

    Measured over: From the first dose of the investigational medicinal product (IMP) to the 90-day Follow-Up Visit

  • Phase 2 - Occurrence of dose interruption, reduction, and discontinuation of IMP due to TEAEs (including related TEAEs)

    Measured over: From the first dose of IMP to the 90-day Follow-Up Visit

  • Phase 2 - Objective response rate (ORR)

    Measured over: Up to approximately 2 years

  • Phase 2 - Best percentage change from baseline in tumor size

    Measured over: Up to approximately 2 years

  • Phase 3 - Progression free survival (PFS) assessed by BICR

    Measured over: Up to approximately 5 years

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 NCT06712316 · record last updated 2026-11-02 · checked 2026-11-09 15:47 UTC

See the official record on ClinicalTrials.gov (NCT06712316) ↗