Phase II Study of SY-3505 in Patients With ALK-positive NSCLC Who Have Failed Prior Second-Generation ALK TKI

Exclusion criteria

• ✕. Patients with known driver alterations other than ALK, such as EGFR, MET, RET, ROS1, NTRK, etc. (If ALK co-mutation exists, the patient can discuss with the investigator for enrollment);
• ✕. Previous treated with any third-generation ALK TKI (including marketed drugs such as loratinib, and unmarketed investigational drugs);
• ✕. History of allergy to any component or excipient of SY-3505 capsules;
• ✕. With other primary malignancies, except those that have been cured and have not recurred within 2 years prior to screening, and those that have been cured of basal or squamous cell carcinoma of the skin, carcinoma in situ of cervix, or carcinoma in situ of breast;
• ✕. The presence of symptomatic primary CNS tumors, symptomatic CNS metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression. Except: Patient had stable CNS disease (no evidence of progression identified by imaging for at least 4 weeks prior to initial administration, and all neurological symptoms had recovered to baseline), no evidence of new or progressive brain metastases, no CNS surgery or radiotherapy within 4 weeks prior to initial administration, and no stereotactic radiosurgery (SRS) within 2 weeks prior to initial administration. Steroid administration was stopped or the dose stabilized within 2 weeks prior to initial administration. (This exception does not include cancerous meningitis, which should be excluded regardless of clinically stable conditions).
• ✕. The following symptoms or diseases occurred prior to initial administration and remain poorly controlled after optimal treatment:
• ✕. Systemic bacterial, viral or fungal infection with uncontrolled activity;
• ✕. Poorly controlled (poorly control refers to the effusion increases significantly within 2 weeks after extraction, with obvious symptoms, requiring further puncture or other intervention) pleural effusion, abdominal effusion or pericardial effusion after intervention (such as drainage) ;