CABozantinib in Non-Small Cell Lung Cancer (NSCLC) Patients With MET Deregulation

Sponsor
Fondazione Ricerca Traslazionale
Study ID
NCT03911193
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cabozantinib — DRUG
    Patients will be treated with cabozantinib 60 mg/daily (cycles each 28 days) until progression, toxicity or patient refusal.

Study Details

This is a multicenter, single arm, phase II study evaluating efficacy in terms of RR in a cohort of NSCLC with MET amplification or MET exon 14 skipping mutation pre-treated or not with MET inhibitors.

Key Dates

First listed
Apr 11, 2019
Start date
Sep 21, 2018
Status verified
Mar 2019
Primary completion
Sep 30, 2020
Completion
Sep 30, 2020

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cabozantinib
    Elegible NSCLC patients with MET exon 14 skipping mutations or MET amplification will be treated with open label orally cabozantinib 60 mg/daily, cycles each 28 days.

Primary Outcome Measure

Response Rate (RR) (complete + partial responses) [ Time Frame: Up to 36 months ]

Central Contacts

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