TGRX-326 Chinese Phase III for Advanced Non-small Cell Lung Cancer (NSCLC) (NCT06082635) | Clinical Trial Compass
Active — Not RecruitingPhase 3
TGRX-326 Chinese Phase III for Advanced Non-small Cell Lung Cancer (NSCLC)
China321 participantsStarted 2023-12-14
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Willing to follow the treatment protocol and visit schedule, and participate in the study with the ICF signed;
* ≥ 18 years of age on the day of ICF signing, regardless of gender.
* Diagnosed as incurable stage IIIB - IV ALK-positive NSCLC;
* Providing prior ALK positive test results at screening;
* Naïve to ALK-inhibitor; patients could be intolerant or have progressive disease from previous first-line chemotherapy;
* Patients could have metastases to central nervous system at screening if the condition is asymptomatic, stable or completely recovered;
* At least one measurable lesion;
* An ECOG PS score within 0-2;
* Adequate bone marrow, liver, kidney, coagulation and pancreatic functions;
* Expected survival ≥ 3 months;
* Willing to take effective contraceptive measures (for men of reproductive potential and women of reproductive age only) from ICF signing to 6 months after last administration of the investigational drug. Women of reproductive age include women before menopause and within 1 year after menopause; those women must have a negative pregnancy test ≤ 7 days prior to the first dose of the investigational drug.
Exclusion Criteria:
* Known hypersensitivity to any of the active ingredients or excipients of TGRX-326 or crizotinib pills; or a history of severe allergic reactions;
* Having another type of cancer except for lung cancer;
* Radiotherapy within 14 days prior to the first dose;
* Received other systemic anti-tumor treatment within 4…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression Free Survival (PFS) by independent review committee (IRC)
Timeframe: Every 8 weeks between Cycle 1 and Cycle 17, and every 12 weeks from Cycle 17 and onwards (every cycle is 28 days); an average of 1.5 years