Status:
ACTIVE_NOT_RECRUITING
TGRX-326 Chinese Phase III for Advanced Non-small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Shenzhen TargetRx, Inc.
Collaborating Sponsors:
Sun Yat-sen University
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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
Detailed Description
This Phase III study aims to evaluate the safety profile and efficacy profile in patients with ALK-positive advanced or metastatic NSCLC and to compare the efficacy and safety of TGRX-326 with that of...
Eligibility Criteria
Inclusion
- 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
- 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 weeks prior to the first dose, or is within 5 half-lives of the said treatment; received traditional Chinese medicine indicated for anti-tumor purposes within 14 days prior to the first dose;
- Major surgery within 4 weeks prior to the first dose;
- Spinal cord compression caused by tumor, unless the subject achieves significant pain control and full recovery of neurological function within 4 weeks prior to the first dose.
- Abnormal gastrointestinal function that affect absorption within the past 6 months;
- History of active pneumonia or clinically significant interstitial pneumonia, or radiation or drug-induced lung disorder with treatment needs;
- Cardiac insufficiency;
- Abnormal and clinically significant QTc on ECG or need of concomitant use of any drug known to prolong QT interval and cause torsades de pointes;
- Uncontrolled hypertension after drug treatment;
- Uncontrolled hyperglycaemia, acute attack of cholelithiasis, and susceptibility to acute pancreatitis;
- Severe or uncontrolled systemic diseases causing expected intolerance to the investigational drug as judged by the investigator;
- Toxic reactions associated with prior surgery and prior antineoplastic therapies that have not recovered and may affect the subject safety as assessed by the investigator.
- Clinically significant active bacterial, fungal or viral infections, including a positive result for hepatitis B surface antigen and HBV DNA ≥ ULN, one or more positive results for hepatitis C antibody or HIV antibody, or the presence of any uncontrolled infection.
- Use of strong CYP3A4 inducers or inhibitors or CYP3A4 substrates with a narrow therapeutic window within two weeks prior to the first dose of the investigational drug;
- Pregnant and breastfeeding female;
- Women of childbearing age who are unwilling or unable to use acceptable methods for contraception during the entire treatment period in the trial and within 6 months after the last dose of the investigational drug (women of childbearing age include: any one with menarche, and those who have not received successful artificial sterilization \[hysterectomy, bilateral fallopian tube ligation, or bilateral oophorectomy\] or premenopausal women); a fertile male patient who is unwilling or unable to take effective contraceptive measures, and whose partner is a woman of childbearing age;
- Being involved in other clinical studies (except for the non-interventional phase of interventional clinical study, such as survival follow-up period); less than 4 weeks from the end of the dose of other investigational drug to the first dose of the investigational drug or 5 half-lives of the previous drug, whichever is shorter;
- Any mental or cognitive disorders which may limit subjects' understanding and implementation of the informed consent form;
- Other situations, such as poor compliance, which are considered by the investigator to be not suitable for participation in the study.
Key Trial Info
Start Date :
December 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2028
Estimated Enrollment :
321 Patients enrolled
Trial Details
Trial ID
NCT06082635
Start Date
December 14 2023
End Date
November 30 2028
Last Update
May 18 2025
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060