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Table 1 Inclusion and exclusion criteria

From: Phase II, open-label, multicenter trial of crizotinib in Japanese patients with advanced non-small cell lung cancer harboring a MET gene alteration: Co-MET study

Inclusion criteria

 1. Histologically or cytologically confirmed NSCLC that is locally advanced or metastatic

 2. Positivity for MET exon 14 skipping mutation or high MET copy number (seven or more) as determined by a validated RT-PCR and/or NGS assay by a designated central testing laboratory (LC-SCRUM)

  *Patients positive for MET exon 14 skipping mutation and high MET copy number of seven or more will be enrolled in cohort 1.

 3. At least one measurable tumor lesion as per RECIST (version 1.1) that has not been irradiated

 4. Women or men, 20 years of age or older

 5. ECOG performance status between 0 and 2

 6. Adequate organ function as defined by the following criteria:

  Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) < 2.5 x upper limit of normal (ULN), or AST and ALT < 5 x ULN if liver function abnormalities are due to underlying malignancy

  Total serum bilirubin < 1.5 x ULN

  Absolute neutrophil count (ANC) > 1500/μL

  Platelets > 50,000/μL

  Hemoglobin > 8.0 g/dL

  Serum creatinine < 2 x ULN

 7. Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment

 8. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

 9. Agreement to use effective contraception during the study period and for at least 90 days after the last dose of crizotinib

Exclusion criteria

 1. Current treatment on another therapeutic clinical trial

 2. Characterized ALK or ROS1-positive rearrangement

 3. Prior therapy specifically directed against MET

 4. Any treatment (chemotherapy, radiation, or surgery) within 2 weeks prior to study entry, except for patients who completed palliative radiation 48 h prior to study entry

 5. Any acute toxicity > Grade 1

 6. Symptomatic brain metastases. Eligible if asymptomatic, or if treated (must be neurologically stable for at least 2 weeks and are not taking unstable or increasing doses of corticosteroids)

 7. Spinal cord compression unless treated with the patient attaining good pain control and stable or recovered neurologic function, carcinomatous meningitis, or leptomeningeal disease

 8. Known interstitial fibrosis or interstitial lung disease

 9. Any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack

 10. Ongoing cardiac dysrhythmias of NCI CTCAE v4.03 Grade > 2, uncontrolled atrial fibrillation of any grade, or QTc > 470 msec

 11. Pregnancy or breastfeeding

 12. Use of drugs or foods after study enrollment that are potent CYP3A4 inhibitors, including but not limited to atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole, and grapefruit or grapefruit juice

 13. Use of drugs after study enrollment that are potent CYP3A4 inducers, including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, and St. John’s wort

 14. Use of drugs after study enrollment that are CYP3A4 substrates with narrow therapeutic indices, including but not limited to dihydroergotamine, ergotamine, pimozide, astemizole, cisapride, and terfenadine

 15. Any other anticancer drugs including traditional Chinese medicine are prohibited

 16. Evidence of active malignancy (other than NSCLC, non-melanoma skin cancer, localized cervical cancer, or localized and presumed cured prostate cancer) within the last 3 years

 17. Other severe acute or chronic medical or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study

 18. Patients whom investigator judges to be inappropriate as participants