Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:41 AM
Study NCT ID:
NCT07392658
Status:
RECRUITING
Last Update Posted:
2026-02-06
First Post:
2025-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Trial of Amivantamab Plus Monochemotherapy in Platinum Unfit NSCLC Patients With EGFR exon20 Insertion Mutations.
Sponsor:
Fondazione Ricerca Traslazionale
Organization:
Study Overview
Official Title:
Phase II Trial of Amivantamab Plus Monochemotherapy in Platinum Unfit NSCLC Patients With EGFR exon20 Insertion Mutations.
Status:
RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMICUTE
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: