Phase II, two arms, parallel, non comparative study with crizotinib in patients with ROS 1 translocation or MET amplification or MET exon 14 mutation

This is a phase II, prospective, two arms, parallel, non comparative study with crizotinib in pretreated NSCLC patients with ROS1 translocation or MET amplification or MET exon 14 mutation (figure 1). Patients with locally advanced or metastatic NSCLC, pretreated with at least one previous chemotherapy line and with at least one measurable tumor lesion will be considered eligible for the trial. All potentially eligible patients will be evaluated for MET and ROS1 by FISH to detect MET amplification or ROS1 translocation. MET mutation will be assessed using direct sequencing or high sensitive methods. After evaluation of inclusion and exclusion criteria, and after signature of informed consent form, all MET amplified or MET exon 14 mutation or ROS1 translocated eligible patients will receive crizotinib 250 mg BID p.o until disease progression, unacceptable toxicity or patient refusal.

Inclusion Criteria:

• Histologically confirmed diagnosis of NSCLC
• Availability of tumor tissue for ROS1 and MET analyses
• Patient positive for ROS1 translocation or MET amplification
• At least one radiological measurable disease according to RECIST criteria (Response Evaluation Criteria in Solid Tumors )
• At least 1 previous standard chemotherapy regimen
• Performance status 0-2 (ECOG)
• Patient compliance to trial procedures
• age ≥ 18 years
• Written informed consent
• Adequate BM function (ANC ≥ 1.5x109/L, Platelets ≥ 100x109/L, HgB > 9g/dl)
• Adequate liver function (bilirubin \