drugset / Trial / NCT07392658

Phase II Trial of Amivantamab Plus Monochemotherapy in Platinum Unfit NSCLC Patients With EGFR exon20 Insertion Mutations.

NCT07392658

Phase 2 Recruiting 33 enrolled Fondazione Ricerca Traslazionale
NaSingle-groupOpen-labelTreatment

Summary

To assess safety and efficacy of amivantamab plus monochemotherapy in terms of ORR, PFS and OS in subjects with EGFR exon20 insertion mutations metastatic non-small cell lung cancer unfit for platinum-based chemotherapy.

Timeline

Start
2025-12-02
Primary completion
2027-10
Completion
2028-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Amivantamab Monoclonal antibody 2400 mg Subcutaneous
Subject Amivantamab Monoclonal antibody 3360 mg Subcutaneous
Background Gemcitabine Small molecule 1000 mg/m2 Intravenous
Background Pemetrexed Small molecule 500 mg/m2 Intravenous