Study of TQ-B3139 in Subjects With Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04056572|
Recruitment Status : Not yet recruiting
First Posted : August 14, 2019
Last Update Posted : August 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|ALK-positive NSCLC||Drug: TQ-B3139||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||135 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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.|
|Estimated Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||October 30, 2021|
|Estimated Study Completion Date :||April 30, 2022|
TQ-B3139 tablet 600mg administered orally, twice daily.
TQ-B3139 is competitive multi-target protein kinase inhibitor of Met/ALK/ROS.
- Objective Response Rate (ORR) [ Time Frame: up to 36 months ]The percentage of participants with a best overall response defined as complete response (CR) or partial response (PR).
- Progression-free survival (PFS) [ Time Frame: up to 36 months ]The time from randomization to the date of the first documentation of objective progression of disease or death due to any cause, whichever occurs first.
- Disease control rate (DCR) [ Time Frame: up to 36 months ]Calculated as the percentage of participants with best overall response of CR, PR, stable disease (SD) and Non-CR/Non-progressive disease (PD).
- Overall survival (OS) [ Time Frame: up to 36 months ]Time from date of randomization to date of death due to any cause.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04056572
|Contact: Li Zhang, Doctorfirstname.lastname@example.org|
|Sun-Yat-Sen University Cancer Center||Not yet recruiting|
|Guangzhou, Guangdong, China, 510050|
|Contact: Li Zhang, Doctor 020-87343088 email@example.com|
|Principal Investigator: Li zhang, Doctor|
|Hunan Cancer Hospital||Not yet recruiting|
|Changsha, Hunan, China, 410013|
|Contact: Nong Yang, Doctor +86-731-88651900 firstname.lastname@example.org|
|Principal Investigator: Nong Yang, Doctor|