A Study of TQ-B3139 Capsules in Subjects With MET-Altered Advanced Non-small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
This is a single-arm, multi-center clinical trial to evaluate the safety and efficacy of TQ-B3139 capsules in patients with MET gene abnormal advanced non-small cell lung cancer.

Official Title
-----------------
A Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of TQ-B3139 in Subjects With MET-Altered Advanced Non-small Cell Lung Cancer

Conditions
-----------------
Non Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: TQ-B3139


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; 2. Life expectancy ≥12 weeks; 3. MET-altered non-small cell lung cancer (NSCLC) ; 4. Has at least one measurable lesion; 5. Previous standard treatment has failed; 6. Adequate organ system function; 7. Left ventricular ejection fraction (LVEF) ≥50%; 8. Understood and signed an informed consent form. Exclusion Criteria: 1. Has diagnosed and/or treated additional malignancy within 3 years prior to the first administration; 2. Has received c-MET inhibitors; 3. Has received other system anti-tumor treatment within 4 weeks before the first administration; 4. Has received major surgical treatment within 4 weeks before the first administration; 5. Has received radiotherapy or any surgery within 2 weeks before the first administration; 6. Acute toxicity that is ≥ Grade 2 caused by previous cancer therapy; 7. Has active infection within 2 weeks before the first administration; 8. Has currently uncontrollable congestive heart failure; 9. Has currently uncontrollable congestive heart failure; 10. Has continuous arrhythmia ≥ Grade 2, uncontrollable atrial fibrillation or QTc interval > 480ms; 11. Has uncontrollable effusion; 12. Has interstitial lung diseases; 13. Has severely unstable central nervous system metastasis; 14. Has active viral infection; 15. Has multiple factors affecting oral medication; 16. Breastfeeding or pregnant women; Men unwilling to use adequate contraceptive measures during the study; 17. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TQ-B3139 capsules<br>TQ-B3139 capsules administered orally. | Drug: TQ-B3139<br>* TQ-B3139 capsules administered 600mg orally, twice daily in 28-day cycle.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) | Percentage of subjects achieving complete response (CR) and partial response (PR). | up to 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) | PFS was defined as the time from the date of study enrollment to the date of the first of the following events, objective disease progression or death due to any cause. | up to 18 months | 
| Disease control rate (DCR) | Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD). | up to 18 months | 
| Overall survival (OS) | OS defined as the time from the first dose to death from any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up. | up to 24 months | 
| Duration of Response (DOR) | DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment. | up to 18 months | 
| Intracranial progression-free survival (CNS-PFS) | The time from enrollment to the first confirmed intracranial progression for brain metastases. | up to 18 months | 
| Intracranial objective response rate (CNS-ORR) | Percentage of subjects achieving intracranial complete response and partial response. | up to 18 months | 
| Time to progress of intracranial disease (CNS-TTP) | The time from the first dose to the first occurrence of intracranial disease progression. | up to 18 months |