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

Sponsor
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Study ID
NCT06569420
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Drug: Foritinib Succinate — OTHER
    SAF-189s: 160 mg QD, 21 days a cycle
  • Drug: Crizotinib — OTHER
    Crizotinib: 250 mg BID, 21 days a cycle

Study Details

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.

Key Dates

First listed
Aug 26, 2024
Start date
Dec 31, 2021
Status verified
Jul 2024
Primary completion
Jul 31, 2025
Completion
Dec 31, 2027

Study Design

Enrollment
275 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Foritinib Succinate
    Foritinib Succinate capsules will be administered orally at a dose of 160 mg QD until disease progression, unacceptable toxicity withdrawal of consent, or death. Other Names: SAF-189s
  • Active Comparator: Control: Crizotinib
    Crizotinib capsules will be administered orally at a dose of 250 mg BID until disease progression, unacceptable toxicity withdrawal of consent, or death.

Primary Outcome Measure

Progression-free survival (PFS) by IRC [ Time Frame: up to 36 months ]

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