Spots Global Cancer Trial Database for A Study Of SY-3505 Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC

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Trial Identification

Brief Title: A Study Of SY-3505 Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC

Official Title: A Phase III Study to Evaluate and Compare the Efficacy and Safety of SY-3505 Versus Crizotinib in Treatment-Naive Patients With Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer

Study ID: NCT06254599

Conditions

Non-small Cell Lung Cancer

Interventions

SY-3505 Capsules

Crizotinib Capsules

Study Description

Brief Summary: A phase 3 study to evaluate the efficacy and safety of SY-3505 vs. crizotinib in patients with ALK-positive non-small cell lung cancer who had not received prior systemic therapy.

Detailed Description: This is a multicenter, randomized controlled phase III trial to evaluate the efficacy and safety of SY-3505 capsule vs. crizotinib capsule in treatment-naive patients with ALK-positive NSCLC. Participants will be randomized in a 2:1 ratio to receive SY-3505, 600 milligrams (mg) orally once daily (QD), or crizotinib, 250 mg orally twice daily (BID). Participants will receive treatment until disease progression, unacceptable toxicity, withdrawal of consent, or death.