MedTrace Logo

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

NCT06569420 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2024-08-26

No results posted yet for this study

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

OTHER

Drug: Foritinib Succinate

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

OTHER

Drug: Crizotinib

Crizotinib: 250 mg BID, 21 days a cycle

Sponsors & Collaborators

  • Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-31
Primary Completion
2025-07-31
Completion
2027-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06569420 on ClinicalTrials.gov