At a glance
ClinicalIndex Comparison RecordPhase 3Active· 321 enrolled
Drug / intervention
TGRX-326 +1 moredrug
Likely dose
TGRX-326 60 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-centered, Randomized, Open-label Phase III Study to Evaluate the Efficacy and Safety of TGRX-326 Comparing With Crizotinib in Patients of Advanced ALK-positive or Metastatic Non-Small Cell Lung Cancer
In Brief
A Phase 3 clinical trial evaluating TGRX-326 and Crizotinib for Non Small Cell Lung Cancer. Active but no longer recruiting, targeting 321 participants across 1 site.
Detailed Summary
This is a multi-center, randomized, open-label, Phase III clinical trial which compares the safety and efficacy of TGRX-326 with crizotinib in patients with ALK-positive advanced or metastatic NSCLC
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon Small Cell Lung Cancer
CountriesChina
CollaboratorsSun Yat-Sen University Cancer Center
Timeline
Phase 3Active
202420252026202720282029
First PostedOct 2023
Enrollment StartDec 2023
Primary CompletionApr 2026
TodayJul 2026
Study CompletionNov 2028
First PostedOct 13, 2023
Enrollment StartDec 14, 2023
Primary CompletionApr 30, 2026
Study CompletionNov 30, 2028
TodayJul 1, 2026
Enrollment to primary: 2.4 yearsPosted 2.7 years ago
Interventions
TGRX-326drug
Subjects will be treated with the investigational drug TGRX-326 at 60 mg once a day in 28-day cycles
Crizotinibdrug
Subjects will be treated with the control drug crizotinib at 250 mg twice a day in 28-day cycles