A Study of TQ-B3139 Capsules in Subjects With MET-Altered Advanced Non-small Cell Lung Cancer
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
1 other identifier
interventional
71
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2020
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2020
CompletedFirst Posted
Study publicly available on registry
May 22, 2020
CompletedStudy Start
First participant enrolled
August 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2022
CompletedSeptember 11, 2020
November 1, 2019
1.5 years
May 19, 2020
September 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR)
Percentage of subjects achieving complete response (CR) and partial response (PR).
up to 18 months
Secondary Outcomes (7)
Progression-free survival (PFS)
up to 18 months
Disease control rate (DCR)
up to 18 months
Overall survival (OS)
up to 24 months
Duration of Response (DOR)
up to 18 months
Intracranial progression-free survival (CNS-PFS)
up to 18 months
- +2 more secondary outcomes
Study Arms (1)
TQ-B3139 capsules
EXPERIMENTALTQ-B3139 capsules administered orally.
Interventions
TQ-B3139 capsules administered 600mg orally, twice daily in 28-day cycle.
Eligibility Criteria
You may qualify if:
- \. 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.
You may not qualify if:
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Anhui Provincial Hospital
Hefei, Anhui, 230000, China
The Sixth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, 100010, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053, China
The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, 100071, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, 530021, China
Sir Run Shaw Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Hangzhou, 310016, China
Zhejiang Cancer Hospital
Hangzhou, Hangzhou, 310022, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300041, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2020
First Posted
May 22, 2020
Study Start
August 11, 2020
Primary Completion
January 31, 2022
Study Completion
October 31, 2022
Last Updated
September 11, 2020
Record last verified: 2019-11