Non-small Cell Lung CancerPhase 2NCT05955391

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

A Phase 2 study testing TGRX-326 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

Search all trials

Trial summary

This is a multi-center, single-arm, open-label, Phase II clinical trial which explores the safety and efficacy of TGRX-326 in patients with ALK-positive advanced NSCLC who have failed prior 2nd-generation ALK treatments due to progressive disease or intolerance. 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
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 164 participants
Where: 1 siteChina
Study dates: 18 Jan 2023to 31 Dec 2025
Phase: Phase 2
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.
With ALK-positive advanced inoperable NSCLC and having disease progression or intolerance after continuous treatment with second-generation ALK inhibitors;
Providing prior ALK positive test results at screening;
Patients could have metastases to central nervous system at screening if the condition is asymptomatic, stable or completely recovered;
Drug discontinuation for ≥ 5 half-lives prior to the first dose for subjects previously treated with ALK inhibitors;

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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 administration of the investigational drug. Women of reproductive age include women before menopause and within 2 years after menopause. Those women must have a negative pregnancy test ≤ 7 days prior to the first dose of the investigational drug.

Who cannot join

Previous use of any third-generation ALK inhibitors other than TGRX-326;
Known hypersensitivity to any of the active ingredients or excipients of TGRX-326 or a history of severe allergic reactions that makes himself/herself unsuitable for TGRX-326 treatment in the judgment of the investigator;
Having another type of cancer except for lung cancer;
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;

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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;
Use within 14 days before the first dose or expected concomitant use during the treatment period of drugs that pose risk of QTC interval prolongation and/or ventricular tachycardia;
Previous antineoplastic treatments within 28 days prior to the first dose of the investigational drug;
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, Open-label, Single-arm Phase II Study to Evaluate the Safety and Efficacy of TGRX-326 Monotherapy in Patients of Advanced ALK-positiveNon-Small Cell Lung Cancer Who Failed 2nd-Generation ALK Inhibitor Therapies

Read the detailed description

This Phase II studyaims to evaluate the safety profile and efficacy profile in patients with ALK-positive advanced NSCLC. The primary purpose of this study is to evaluate the efficacy profile of TGRX-326, with the objective response rate (ORR) as end point. Secondary objectives include evaluating efficacy profile of other endpoints and safety profiles of the investigational drug. Exploratory objective includes the evaluation of population pharmacokinetic (PK) profile of TGRX-326.

Conditions: Non-small Cell Lung Cancer
Being tested: TGRX-326
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
Subjects will be treated with the investigational drug TGRX-326 at 60 mg once day in 21-day cycles

Study groups in NCT05955391
Study group	Role	What they receive
Experimental: TGRX-326	Experimental	Subjects to be treated with the investigational drug TGRX-326 at 60 mg once day in 21-day cycles. Receives: Drug: TGRX-326

What is being measured

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

Objective Response Rate (ORR)
ORR defined by the ratio of patients who reachedthe treatment response; ORR as evaluated by independed review committee (IRC)
Measured: Every 2 cycles between Cycle 1 and Cycle 17, and every 12 weeks from Cycle 17 and onwards (every cycle is 21 days); an average of 1.5 years

Secondary outcomes (12)

Disease Control Rate (DCR)
DCR defined by the ratio of patients who reached the treatment response or maintained as stable desease; DCR as evaluated by IRC and investigator
Measured: Every 2 cycles between Cycle 1 and Cycle 17, and every 12 weeks from Cycle 17 and onwards (every cycle is 21 days); an average of 1.5 years
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 2 cycles between Cycle 1 and Cycle 17, and every 12 weeks from Cycle 17 and onwards (every cycle is 21 days); an average of 1.5 years
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 2 cycles between Cycle 1 and Cycle 17, and every 12 weeks from Cycle 17 and onwards (every cycle is 21 days); an average of 1.5 years
Progression Free Survival (PFS)
PFS defined by the time from randomization to progressive disease or death of any cause; PFS as evaluated by IRC and investigator.
Measured: Every 2 cycles between Cycle 1 and Cycle 17, and every 12 weeks from Cycle 17 and onwards (every cycle is 21 days); an average of 1.5 years
Intracranial Objective Response Rate (IC-ORR)
IC-ORR defined by the ratio of patients who reached the intracranial treatment response; ORR as evaluated by independed review committee (IRC) and investigator.
Measured: Every 2 cycles between Cycle 1 and Cycle 17, and every 12 weeks from Cycle 17 and onwards (every cycle is 21 days); an average of 1.5 years
Intracranial Disease Control Rate (IC-DCR)
IC-DCR defined by the ratio of patients who reached the treatment response intracranially or maintained as stable desease; IC-DCR as evaluated by IRC and investigator
Measured: Every 2 cycles between Cycle 1 and Cycle 17, and every 12 weeks from Cycle 17 and onwards (every cycle is 21 days); an average of 1.5 years
Intracranial Duration of Response (IC-DOR)
IC-DOR defined as the duration from first occurence of Intracranial treatment response to progressive disease/relapse; DOR as evaluated by IRC and investigator
Measured: Every 2 cycles between Cycle 1 and Cycle 17, and every 12 weeks from Cycle 17 and onwards (every cycle is 21 days); an average of 1.5 years
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 2 cycles between Cycle 1 and Cycle 17, and every 12 weeks from Cycle 17 and onwards (every cycle is 21 days); an average of 1.5 years
Intracranial Progression Free Survival (IC-PFS)
IC-PFS defined by the time from randomization to progressive disease or death of any cause inpatients with intracranial lesions; PFS as evaluated by IRC and investigator.
Measured: Every 2 cycles between Cycle 1 and Cycle 17, and every 12 weeks from Cycle 17 and onwards (every cycle is 21 days); an average of 1.5 years
Overall Survival (OS)
OS defined by the time from randomization to death of any cause; PFS as evaluated by IRC and investigator.
Measured: Every 2 cycles between Cycle 1 and Cycle 17, and every 12 weeks from Cycle 17 and onwards (every cycle is 21 days); an average of 1.5 years
Adverse Events (AEs)
To record and analyse subjects with adverse events (AEs)
Measured: Through completion of the study, an average of 1.5 years
Serious Adverse Events (SAEs)
To record and analyse subjects with serious adverse events (SAEs)
Measured: Through completion of the study, an average of 1.5 years

Timeline

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

18 Jan 202331 Dec 2025

First posted21 Jul 2023
Study start18 Jan 2023
Primary completion29 Dec 2024
Study completion31 Dec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 164 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05955391
Sponsor's protocol ID: TGRX-326-2001-NSCLC-CN
Status last verified: May 2025
First submitted: 10 Jul 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-centered, Open-label, Single-arm Phase II Study to Evaluate the Safety and Efficacy of TGRX-326 Monotherapy in Patients of Advanced ALK-positiveNon-Small Cell Lung Cancer Who Failed 2nd-Generation ALK Inhibitor Therapies
ClinicalTrials.gov ID: NCT05955391
Acronym / sponsor ID: TGRX-326-2001-NSCLC-CN
Conditions: Non-small Cell Lung Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 164 participants (actual)
Lead sponsor: Shenzhen TargetRx Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: Sun Yat-Sen University Cancer Center, Tongji Hospital, Sichuan Cancer Hospital and Research Institute, The First Affiliated Hospital of Zhengzhou University, West China Hospital, First Affiliated Hospital of Zhejiang University, Jilin Provincial Tumor Hospital, Hunan Cancer Hospital, Shandong Cancer Hospital and Institute, Jiangxi Provincial Cancer Hospital, First Hospital of China Medical University, The Affiliated Hospital of Qingdao University, Liaoning Cancer Hospital & Institute, Haerbin Medical University Cancer Hospital, Xinxiang Central Hospital, Xiangyang Central Hospital, Mianyang Central Hospital, Zhejiang Cancer Hospital, Henan Cancer Hospital, First Affiliated Hospital, Sun Yat-Sen University, The First Affiliated Hospital of Bengbu Medical University, Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center, Bingzhou Medical University Affiliated Hospital, Fujian Cancer Hospital, Ningbo No. 1 Hospital, First Affiliated Hospital Xi'an Jiaotong University, The Second Affiliated Hospital of AFMU, Yunnan Cancer Hospital, Capital Medical School Beijing Chest Hospital, Shijiazhuang People's Hospital, Tianjin Cancer Hospital Airport Hospital, Affiliated Cancer Hospital of Guizhou Medical University, Nanchang University First Affiliated Hospital, Jingzhou First People's Hospital, Shanghai Chest Hospital
Study start: 18 Jan 2023 (actual)
Primary completion: 29 Dec 2024 (actual)
Study completion: 31 Dec 2025 (estimated)
First posted: 21 Jul 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Experimental: TGRX-326	Experimental	Drug: TGRX-326Subjects to be treated with the investigational drug TGRX-326 at 60 mg once day in 21-day cycles.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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.
With ALK-positive advanced inoperable NSCLC and having disease progression or intolerance after continuous treatment with second-generation ALK inhibitors;
Providing prior ALK positive test results at screening;
Patients could have metastases to central nervous system at screening if the condition is asymptomatic, stable or completely recovered;

Key exclusion criteria (22 listed)

Previous use of any third-generation ALK inhibitors other than TGRX-326;
Known hypersensitivity to any of the active ingredients or excipients of TGRX-326 or a history of severe allergic reactions that makes himself/herself unsuitable for TGRX-326 treatment in the judgment of the investigator;
Having another type of cancer except for lung cancer;
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TGRX-326Subjects will be treated with the investigational drug TGRX-326 at 60 mg once day in 21-day cycles	Drug	Experimental: TGRX-326

Primary outcome

Objective Response Rate (ORR)
Time frame: Every 2 cycles between Cycle 1 and Cycle 17, and every 12 weeks from Cycle 17 and onwards (every cycle is 21 days); an average of 1.5 years
ORR defined by the ratio of patients who reachedthe treatment response; ORR as evaluated by independed review committee (IRC)

12 secondary outcomes

Disease Control Rate (DCR)
Time frame: Every 2 cycles between Cycle 1 and Cycle 17, and every 12 weeks from Cycle 17 and onwards (every cycle is 21 days); an average of 1.5 years
Duration of Response (DOR)
Time frame: Every 2 cycles between Cycle 1 and Cycle 17, and every 12 weeks from Cycle 17 and onwards (every cycle is 21 days); an average of 1.5 years
Time to Response (TTR)
Time frame: Every 2 cycles between Cycle 1 and Cycle 17, and every 12 weeks from Cycle 17 and onwards (every cycle is 21 days); an average of 1.5 years
Progression Free Survival (PFS)
Time frame: Every 2 cycles between Cycle 1 and Cycle 17, and every 12 weeks from Cycle 17 and onwards (every cycle is 21 days); an average of 1.5 years
Intracranial Objective Response Rate (IC-ORR)
Time frame: Every 2 cycles between Cycle 1 and Cycle 17, and every 12 weeks from Cycle 17 and onwards (every cycle is 21 days); an average of 1.5 years
Intracranial Disease Control Rate (IC-DCR)
Time frame: Every 2 cycles between Cycle 1 and Cycle 17, and every 12 weeks from Cycle 17 and onwards (every cycle is 21 days); an average of 1.5 years
Intracranial Duration of Response (IC-DOR)
Time frame: Every 2 cycles between Cycle 1 and Cycle 17, and every 12 weeks from Cycle 17 and onwards (every cycle is 21 days); an average of 1.5 years
Intracranial Time to Response (IC-TTR)
Time frame: Every 2 cycles between Cycle 1 and Cycle 17, and every 12 weeks from Cycle 17 and onwards (every cycle is 21 days); an average of 1.5 years
Intracranial Progression Free Survival (IC-PFS)
Time frame: Every 2 cycles between Cycle 1 and Cycle 17, and every 12 weeks from Cycle 17 and onwards (every cycle is 21 days); an average of 1.5 years
Overall Survival (OS)
Time frame: Every 2 cycles between Cycle 1 and Cycle 17, and every 12 weeks from Cycle 17 and onwards (every cycle is 21 days); an average of 1.5 years
Adverse Events (AEs)
Time frame: Through completion of the study, an average of 1.5 years
Serious Adverse Events (SAEs)
Time frame: Through completion of the study, an average of 1.5 years

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Li Zhang, MD principal investigator

Study Principal Investigator

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TGRX-326 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 22 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Objective Response Rate (ORR) (time frame: Every 2 cycles between Cycle 1 and Cycle 17, and every 12 weeks from Cycle 17 and onwards (every cycle is 21 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 NCT05955391.

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.