SY-3505 is a potent, brain-penetrant, third-generation ALK tyrosine kinase inhibitor (TKI) with preclinical activity against both wild-type and most known resistance mutations of ALK occurring in first-generation and second-generation ALK TKI-resistant patients.~In this phase 2 study, patients with locally advanced or metastatic NSCLC who have progressed on or are intolerant to second-generation ALK TKI will be treated with SY-3505 capsules at 600 mg once daily (QD) orally until disease progression, refusal or unacceptable toxicity. Cycles of treatment are every 21 days with continuous dosing of SY-3505. During the study, patients will be followed-up for safety and efficacy evaluation at study protocol defined time points.
This is an open-label, single-arm, multicenter, phase II study to evaluate the efficacy and safety of SY-3505 capsule in patients with locally advanced or metastatic NSCLC who have progressed on or are intolerant to second-generation ALK tyrosine kinase inhibitor (TKI).