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ACTIVE NOT RECRUITING
NCT06569420
PHASE3

Study Of Comparing SAF-189s With Crizotinib In First Line ALK-Positive Advanced and Metastatic NSCLC

Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

View on ClinicalTrials.gov

Summary

This randomized, multicenter, Phase III, open-label study will evaluate the efficacy and safety of SAF-189s versus crizotinib treatment in participants with treatment-naive ALK-positive advanced NSCLC. Participants will be randomized 1:1 into one of the two treatment groups to receive either SAF-189s (160 milligrams \[mg\] once daily \[QD\]) or crizotinib (250 mg BID) orally, respectively.

Official title: A Randomized, Multicenter, Phase III Open-label Study: Efficacy and Safety of Comparing SAF-189s With Crizotinib in First-line Anaplastic Lymphoma Kinase-positive Advanced and Metastatic NSCLC

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

275

Start Date

2021-12-31

Completion Date

2027-12-31

Last Updated

2024-08-26

Healthy Volunteers

No

Interventions

OTHER

Drug: Foritinib Succinate

SAF-189s: 160 mg QD, 21 days a cycle

OTHER

Drug: Crizotinib

Crizotinib: 250 mg BID, 21 days a cycle

Locations (1)

Shanghai Pulmonary Hospital

Shanghai, China