Phase II Trial of Amivantamab Plus Monochemotherapy in Platinum Unfit NSCLC Patients With EGFR exon20 Insertion Mutations.
Fondazione Ricerca Traslazionale
33 participants
Dec 2, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
Subcutaneous amivantamab at the dose of 1600 mg (2240 mg, ≥80 kg) on cycle 1 day 1, than at the dose of 2400 mg (3360 mg, ≥80 kg) on cycle 1 day 8 and 15 and than every 3 weeks starting from cycle 2 day 1, in combination with monochemoterapy (investigator's choice between pemetrexed 500 mg/m2 IV Q3W or gemcitabine 1000 mg/m2 IV day 1-8 Q3W)
Locations(1)
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NCT07392658