TGRX-326 Chinese Phase III for Advanced Non-small Cell Lung Cancer (NSCLC)

Inclusion Criteria: * Willing to follow the treatment protocol and visit schedule, and participate in the study with the ICF signed; * ≥ 18 years of age on the day of ICF signing, regardless of gender. * Diagnosed as incurable stage IIIB - IV ALK-positive NSCLC; * Providing prior ALK positive test results at screening; * Naïve to ALK-inhibitor; patients could be intolerant or have progressive disease from previous first-line chemotherapy; * Patients could have metastases to central nervous system at screening if the condition is asymptomatic, stable or completely recovered; * At least one measurable lesion; * An ECOG PS score within 0-2; * Adequate bone marrow, liver, kidney, coagulation and pancreatic functions; * Expected survival ≥ 3 months; * Willing to take effective contraceptive measures (for men of reproductive potential and women of reproductive age only) from ICF signing to 6 months after last administration of the investigational drug. Women of reproductive age include women before menopause and within 1 year after menopause; those women must have a negative pregnancy test ≤ 7 days prior to the first dose of the investigational drug. Exclusion Criteria: * Known hypersensitivity to any of the active ingredients or excipients of TGRX-326 or crizotinib pills; or a history of severe allergic reactions; * Having another type of cancer except for lung cancer; * Radiotherapy within 14 days prior to the first dose; * Received other systemic anti-tumor treatment within 4…