Pretreated metastatic non-small-cell lung cancer with MET amplification or ROS1 translocation MedDRA version: 17.0 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: XALKORI 250 mg hard capsule
Product Name: CRIZOTINIB
Product Code: PF-02341066
Pharmaceutical Form: Capsule, hard
Trade Name: XALKORI 200 mg capsule hard
Product Name: CRIZOTINIB
Product
Sponsors
Fondazione Ricerca Traslazionale (FoRT)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: • Response rate to crizotinib in patients with ROS1 translocation or MET amplification ;Timepoint(s) of evaluation of this end point: 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Sopravvivenza libera da progressione (PFS) • Sopravvivenza globale (OS) • Tossicità • Correlazione con biomarkers tumorali addizionali in tessuti tumorali o nel sangue • 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 | — |
Countries
Italy
Contacts
Public ContactFondazione Ricerca Traslazionale
Fondazione Ricerca Traslazionale (FoRT)
Outcome results
None listed