Crizotinib in Pretreated Metastatic Non-small-cell Lung Cancer With MET Amplification or ROS1 Translocation (METROS)

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione Ricerca Traslazionale
• Treatments: Crizotinib

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

• 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 (bilirubinpresent of liver metastases).

• Normal level of alkaline phosphatase and creatinine.

• If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of approved contraceptive method [intrauterine contraceptive device (IUD), birth control pills, or barrier device] during and for ninety(90) days after end of treatment.

Exclusion Criteria:

• No tumor tissue available or patient negative for ROS1 translocation or MET amplification

• Absence of any measurable lesion

• For ROS1+ patients: Previous therapy with crizotinib or any anti-ALK agent

• 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.

• Previous radiotherapy on the target lesion(s). If all sites were included in radiotherapy fields patient is eligible only if there is evidence of progressive disease after completion of radiotherapy.

• Symptomatic brain metastases

• Diagnosis of any other malignancy during the last 5 years, except for in situ carcinoma of cervix uteri and squamous cell carcinoma of the skin

• Pregnancy or lactating

• Other serious illness or medical condition potentially interfering with the study