Crizotinib in pretreated metastatic non-small-cell lung cancer with MET amplification or ROS1 translocation (METROS)

Conditions: Pretreated metastatic non-small-cell lung cancer with MET amplification or ROS1 translocation
MedDRA version: 17.0Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2014-001263-12-IT

Lead Sponsor: Fondazione Ricerca Traslazionale (FoRT)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•Histologically confirmed diagnosis of NSCLC
•Availability of tumor tissue for ROS1, and MET analyses
•Patient positive for ROS1 translocation or MET amplification
•Radiological measurable disease according to RECIST criteria
•At least 1 previous standard chemotherapy regimen
•Performance status 0-2 (ECOG)
•Patient compliance to trial procedures
•Age = 18 years
•Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

•No tumor tissue available or patient negative for ROS1 translocation or MET amplification
•Absence of any measurable lesions
•For ROS1+ patients: Previous therapy with crizotinib or any anti-ALK agents
•For MET amplified patients: Evidence of MET amplification in tumor tissue collected in EGFR mutant patient at time of EGFR-TKI acquired resistance occurrence. An EGFR mutant patient is eligible if MET amplification is detected in a tumor specimen collected before starting an EGFR-TKI
•No previous chemotherapy
•Concomitant radiotherapy or chemotherapy
•Symptomatic brain metastases
•Diagnosis of any other malignancy during the last 5 years, except for in situ carcinoma of cervix uteri and cutaneous squamous cell carcinoma
•Pregnancy or lactating

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy and safety and tolerability of Crizotinib in pretreated metastatic non-small-cell lung cancer with MET amplification or ROS1 translocation ;Secondary Objective: Not applicable;Primary end point(s): Co-Primary:<br>•Response rate to crizotinib in patients with ROS1 translocation or MET amplification<br><br>;Timepoint(s) of evaluation of this end point: 24 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Sopravvivenza libera da progressione (PFS)<br>•Sopravvivenza globale (OS)<br>•Tossicità<br>•Correlazione con biomarkers tumorali addizionali in tessuti tumorali o nel sangue<br>•Risposta in accordo con i diversi livelli di traslocazione ROS1 o amplificazione MET (ratio>2.2 e <5 contro ratio =5);Timepoint(s) of evaluation of this end point: 24 months