Study of TQ-B3139 in Subjects With Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib
A Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of TQ-B3139 in Patients With Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib.
1 other identifier
interventional
135
1 country
2
Brief Summary
To evaluate the efficacy and safety of TQ-B3139 in subjects with ALK-positive non-small cell lung cancer that have demonstrated progression during or after crizotinib treatment whether or not previously treated with cytotoxic chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2019
2 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
August 12, 2019
CompletedStudy Start
First participant enrolled
August 13, 2019
CompletedFirst Posted
Study publicly available on registry
August 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2022
CompletedOctober 30, 2019
May 1, 2019
2.2 years
August 12, 2019
October 29, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR)
The percentage of participants with a best overall response defined as complete response (CR) or partial response (PR).
up to 36 months
Secondary Outcomes (3)
Progression-free survival (PFS)
up to 36 months
Disease control rate (DCR)
up to 36 months
Overall survival (OS)
up to 36 months
Study Arms (1)
TQ-B3139
EXPERIMENTALTQ-B3139 tablet 600mg administered orally, twice daily.
Interventions
Eligibility Criteria
You may qualify if:
- and 75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
- Life expectancy ≥12 weeks.
- Histologically or cytologically confirmed diagnosis of advanced or metastatic NSCLC that is ALK-positive.
- Has progressive disease during or after crizotinib treatment.
- Has a measurable disease.
- Adequate organ system function.
- Understood and signed an informed consent form.
You may not qualify if:
- Diagnosed and/or treated additional malignancy within 5 years prior to randomization.
- Hypersensitivity to TQ-B3139 capsule.
- Has received ALK TKIs other than crizotinib.
- Has received any cancer therapy within 4 weeks or 5 times of t1/2.
- Has received major surgery within 4 weeks.
- Has received any radiotherapy or minor surgery within 2 weeks.
- Acute toxicity ≥ Grade 2 caused by previous cancer therapy.
- Has active viral, bacterial and fungal infections within 2 weeks.
- Has serious cardiovascular diseases.
- Has currently uncontrollable congestive heart failure.
- Has continuous arrhythmia ≥ Grade 2, any degree of poor controlled atrial fibrillation or QTc interval \> 480ms.
- Has interstitial fibrosis or interstitial lung disease.
- Brain metastases with symptom or carcinomatous meningitis.
- Has active hepatitis B or hepatitis C.
- Has multiple factors affecting oral medication.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Sun-Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510050, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
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
August 12, 2019
First Posted
August 14, 2019
Study Start
August 13, 2019
Primary Completion
October 30, 2021
Study Completion
April 30, 2022
Last Updated
October 30, 2019
Record last verified: 2019-05