X-396 Capsule in Advanced NSCLC Patients With ROS1 Gene Rearrangement
|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: NCT03608007|
Recruitment Status : Recruiting
First Posted : July 31, 2018
Last Update Posted : July 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer ROS1 Gene Rearrangement||Drug: X-396 Capsule||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||69 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II, Open-Label, Single Arm Study of the Efficacy and Safety of X-396 Capsule in Patients With ROS1 Positive Advanced NSCLC|
|Actual Study Start Date :||June 15, 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||May 2020|
Experimental: X-396 Capsule
Single-arm trial whereby all consented, enrolled, eligible patients receive X-396 capsule, 225 mg once daily.
Drug: X-396 Capsule
225 mg once daily
Other Name: Ensartinib
- Objective response rate (ORR) based on independent radiology review (IRC) [ Time Frame: 12 weeks ]ORR per RECIST 1.1 calculated as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR), based on IRC.
- ORR based on investigator assessment [ Time Frame: 12 weeks ]ORR per RECIST 1.1 calculated as the proportion of patients with a best overall response defined as CR or PR, based on investigator's assessment
- Disease control rate (DCR) [ Time Frame: 12 weeks ]DCR defined as the percentage of patients who have achieved CR, PR and stable disease (SD), based on RECIST 1.1 measured by IRC or investigator
- Intracranial overall response rate (iORR) by IRC and investigator assessment [ Time Frame: 12 weeks ]iORR calculated as the ORR (CR+PR) of lesions in the brain for patients who have measurable disease in the brain at baseline.
- Progression-free survival (PFS) based on IRC or investigator [ Time Frame: 36 months ]PFS defined as time from first dose of X-396 capsule to disease progression or death due to any cause, based on RECIST 1.1.
- Time to progression (TTP) based on IRC or investigator [ Time Frame: 36 months ]TTP defined as time from first dose of X-396 capsule to disease progression, based on RECIST 1.1.
- Duration of response (DOR) based on IRC or investigator [ Time Frame: 36 months ]DOR defined as time from documentation of tumor response (CR or PR) to disease progression or death, based on RECIST 1.1
- Overall survival (OS) [ Time Frame: 36 months ]OS, defined as time from first dose of X-396 to death due to any cause.
- Change From Baseline Scores on the functional assessment of cancer therapy - Lung (FACT-L) quality of life questionnaire [ Time Frame: 36 months ]The FACT-L questionnaire consisted of several major aspects of life (Physical, social/family, emotional, and functional well-being) as well as lung cancer subscale (symptoms, cognitive function, regret of smoking). Scores for item ranging from 0 (not at all) to 4 (very much).
- Incidence of patients experiencing adverse events (AE) [ Time Frame: 36 months ]
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): NCT03608007
|Contact: Jinxiao Xufirstname.lastname@example.org|
|Hangzhou, Zhejiang, China, 311100|
|Contact: Jinxiao Xu|
|Principal Investigator: Shun Lu, Ph.D|