RecruitingPhase 2NCT07392658

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


Sponsor

Fondazione Ricerca Traslazionale

Enrollment

33 participants

Start Date

Dec 2, 2025

Study Type

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

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing the combination of amivantamab (a targeted antibody drug) plus a single chemotherapy drug for people with a specific type of non-small cell lung cancer (NSCLC) caused by an EGFR exon 20 insertion mutation, who are not able to tolerate platinum-based chemotherapy. **You may be eligible if...** - You are 18 or older - You have stage IV or recurrent non-squamous non-small cell lung cancer with an EGFR exon 20 insertion mutation (confirmed by genetic testing) - You have not received any prior systemic treatment for this cancer - You are not suitable for platinum-based chemotherapy (due to poor kidney function, age over 80, neurological problems, or allergy to platinum) - You have at least one measurable tumor **You may NOT be eligible if...** - You have already received systemic treatment for this lung cancer - You can tolerate platinum-based chemotherapy - You have uncontrolled or symptomatic brain metastases - You have serious heart, liver, or autoimmune problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAmivantamab

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)

I.F.O. Istituti Fisioterapici Ospitalieri Istituto Nazionale Tumori "Regina Elena", Medical Oncology 2

Roma, Roma (RM), Italy

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NCT07392658


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