Overview

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 (bilirubin present 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