Trials / Active Not Recruiting
Active Not RecruitingNCT06569420
Study Of Comparing SAF-189s With Crizotinib In First Line ALK-Positive Advanced and Metastatic NSCLC
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
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 275 (actual)
- Sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Drug: Foritinib Succinate | SAF-189s: 160 mg QD, 21 days a cycle |
| OTHER | Drug: Crizotinib | Crizotinib: 250 mg BID, 21 days a cycle |
Timeline
- Start date
- 2021-12-31
- Primary completion
- 2025-07-31
- Completion
- 2027-12-31
- First posted
- 2024-08-26
- Last updated
- 2024-08-26
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06569420. Inclusion in this directory is not an endorsement.