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Non Small Cell Lung CancerPhase 3NCT06082635

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

A Phase 3 study testing TGRX-326 and Crizotinib in people with Non Small Cell Lung Cancer, run by Shenzhen TargetRx Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
TGRX-326 and Crizotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
321 participants
Where
1 siteChina
Study dates
14 Dec 2023to 30 Nov 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: 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

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

Read the 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 crizotinib. The primary purpose of this study is to evaluate and compare the efficacy profile of TGRX-326 with crizotinib, with progression-free survival (PFS) as evaluated by independent review committee (IRC) as end point. Secondary objectives include comparing efficacy profile of other endpoints and safety profiles of the investigational drug with crizotinib. Exploratory objective includes the evaluation of population pharmacokinetic (PK) profile of TGRX-326 and efficacy of TGRX-326 in ALK-positive advanced NSCLC patients determined as progressive disease after crizotinib treatment.

Being tested
TGRX-326, Crizotinib
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TGRX-326Drug

    Also called TGRX-326 QD (once a day)

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

  • CrizotinibDrug

    Also called Crizotinib 250 mg BID (twice a day)

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

Study groups in NCT06082635
Study groupRoleWhat they receive
TGRX-326ExperimentalSubjects to be treated with the investigational drug TGRX-326 at 60 mg once day in 28-day cycles.
Receives: Drug: TGRX-326
CrizotinibActive comparatorSubjects to be treated with the active control drug crizotinib at 250 mg twice day in 28-day cycles.
Receives: Drug: Crizotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 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)

  1. Progression Free Survival (PFS) by investigator

    PFS defined by the time from randomization to progressive disease or death of any cause; PFS as evaluated by investigator.

    Measured: 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

  2. One-year Progression Free Survival (PFS)

    One-year PFS defined by the time from randomization to progressive disease or death of any cause, with data collection up to 1 year from randomization; one-year PFS as evaluated by investigator or IRC.

    Measured: 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

  3. Objective Response Rate (ORR)

    ORR defined by the ratio of patients who reached the treatment response; ORR as evaluated by independent review committee (IRC) and investigator

    Measured: 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

  4. Duration of Response (DOR)

    DOR defined as the duration from first occurence of treatment response to progressive disease/relapse; DOR as evaluated by IRC and investigator

    Measured: 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

  5. Disease Control Rate (DCR)

    DCR defined by the ratio of patients who reached the treatment response or maintained as stable disease; DCR as evaluated by IRC and investigator

    Measured: 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

  6. Time to Response (TTR)

    TTR defined by the time from the start of treatment to the first ORR; TTR as evaluated by IRC and investigator

    Measured: 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

  7. Intracranial Objective Response Rate (IC-ORR)

    IC-ORR defined by the ratio of patients who reached the intracranial treatment response; ORR as evaluated by IRC and investigator.

    Measured: 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

  8. Intracranial Disease Control Rate (IC-DCR)

    IC-DCR defined by the ratio of patients who reached the treatment response intracranially or maintained as stable disease; IC-DCR as evaluated by IRC and investigator

    Measured: 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

  9. Intracranial Duration of Response (IC-DOR)

    IC-DOR defined as the duration from first occurrence of Intracranial treatment response to progressive disease/relapse; DOR as evaluated by IRC and investigator

    Measured: 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

  10. Intracranial Time to Response (IC-TTR)

    IC-TTR defined by the time from the start of treatment to the first IC-ORR; TTR as evaluated by IRC and investigator

    Measured: 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

  11. Intracranial Progression Free Survival (IC-PFS)

    IC-PFS defined by the time from randomization to progressive disease or death of any cause in patients with intracranial lesions; PFS as evaluated by IRC and investigator.

    Measured: 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

  12. Overall Survival (OS)

    OS defined by the time from randomization to death of any cause

    Measured: 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

  13. Adverse Events (AEs)

    To record and analyze subjects with adverse events (AEs)

    Measured: At Screening; Day 1 of every Cycle (each cycle is 28 days) until end of study

  14. Serious Adverse Events (SAEs)

    To record and analyze subjects with serious adverse events (SAEs)

    Measured: At Screening; Day 1 of every Cycle (each cycle is 28 days) until end of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2023
  2. Study start14 Dec 2023
  3. Primary completion30 Apr 2026 (estimated)
  4. Study completion30 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
321 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06082635
Sponsor's protocol ID
TGRX-326-3001-NSCLC-CN
Status last verified
May 2025
First submitted
8 Oct 2023
Last updated
18 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TGRX-326 and Crizotinib in people with Non Small Cell Lung Cancer, run by Shenzhen TargetRx Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) by independent review committee (IRC) (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06082635.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.

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Clinical Trial NCT06082635 | AzTrials