NCT07392658

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Fondazione Ricerca Traslazionale · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a phase II multicenter study assessing efficacy and safety of amivantamab plus monochemotherapy in patients with EGFR exon20 insertion mutations metastatic NSCLC who are unfit for platinum-based chemotherapy. After evaluation of all inclusion and exclusion criteria and after informed consent signature all eligible patients will be treated with 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 or gemcitabine), until disease progression, unacceptable toxicity or patient refusal. Disease assessment will be performed every 8 weeks. Response will be evaluated according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Toxicity will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.

Conditions

• Metastatic NSCLC - Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Amivantamab	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)

Timeline

• Start date: 2025-12-02
• Primary completion: 2027-10-01
• Completion: 2028-10-01
• First posted: 2026-02-06
• Last updated: 2026-02-06

Locations

1 site across 1 country: Italy