TGRX-326 Chinese Phase III for Advanced Non-small Cell Lung Cancer (NSCLC)

NCT06082635 | Active Not Recruiting Phase 3

• 1 other identifier: TGRX-326-3001-NSCLC-CN
• Study Type: interventional
• Target: 321
• Locations: 1 country
• Sites: 1

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

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) by independent review committee (IRC)

  PFS defined by the time from randomization to progressive disease or death of any cause; PFS as evaluated by independent review committee (IRC).

  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

Secondary Outcomes (14)

• Progression Free Survival (PFS) by investigator

  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

• One-year Progression Free Survival (PFS)

  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

• Objective Response Rate (ORR)

  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

• Duration of Response (DOR)

  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

• Disease Control Rate (DCR)

  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

Other Outcomes (1)

• Plasma Cmax

  Day 1 of Cycle 2, 3 and 5 (each cycle is 28 days)

Study Arms (2)

TGRX-326

EXPERIMENTAL

Subjects to be treated with the investigational drug TGRX-326 at 60 mg once day in 28-day cycles.

Drug: TGRX-326

Crizotinib

ACTIVE COMPARATOR

Subjects to be treated with the active control drug crizotinib at 250 mg twice day in 28-day cycles.

Drug: Crizotinib

Interventions

TGRX-326 DRUG

Subjects will be treated with the investigational drug TGRX-326 at 60 mg once a day in 28-day cycles

Also known as: TGRX-326 QD (once a day)

TGRX-326

Crizotinib DRUG

Subjects will be treated with the control drug crizotinib at 250 mg twice a day in 28-day cycles

Also known as: Crizotinib 250 mg BID (twice a day)

Crizotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen TargetRx, Inc.: lead
• Sun Yat-sen University: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Crizotinib; BID protein, human

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminopyridines; Pyridines

Study Officials

• Li Zhang, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2023
• First Posted: October 13, 2023
• Study Start: December 14, 2023
• Primary Completion: April 30, 2026
• Study Completion (Estimated): November 30, 2028
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)