X-396 Capsule in Patients With ALK-positive Non-small Cell Lung Cancer 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: NCT03215693|
Recruitment Status : Recruiting
First Posted : July 12, 2017
Last Update Posted : December 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer||Drug: X-396 capsule||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||152 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Multicenter, Single-arm Study to Evaluate Safety and Efficacy of X-396 Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib|
|Actual Study Start Date :||September 28, 2017|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: X-396 capsule
225mg once daily
Drug: X-396 capsule
225mg once daily
Other Name: Ensartinib
- Objective response rate (ORR) based on independent radiology review [ Time Frame: 24 months ]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).
- ORR based on investigator assessment [ Time Frame: 24 months ]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).
- Progression-free survival (PFS) as assessed by independent radiology review and investigator [ Time Frame: 36 months ]PFS, defined as time from first dose of X-396 to progression or death due to any cause.
- Overall survival (OS) [ Time Frame: 36 months ]OS, defined as time from first dose of X-396 to death due to any cause.
- Overall intracranial response rate (OIRR) by independent radiology review and investigator assessment [ Time Frame: 24 months ]OIRR calculated as the ORR (CR+PR) of lesions in the brain for patients who have measureable disease in the brain at baseline.
- Patient reported time to deterioration (TTD) as measured by EORTC C30/LC13 QoL questionnaire [ Time Frame: 24 months ]Time to deterioration (TTD) is defined at the time from date of randomization to a worsening of at least 10 points (on a 100 point scale) in each item score of the EORTC C30/LC13
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): NCT03215693
|Contact: Li Zhang, MDemail@example.com|
|Beijing Cancer Hospital||Recruiting|
|Contact: Jian Fang, MD 13701224460 firstname.lastname@example.org|
|Principal Investigator: Jun Zhao, MD|
|Beijing Chest Hospital，Capital Medical University||Recruiting|
|Contact: Shucai Zhang, MD 13901297065 email@example.com|
|Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences||Recruiting|
|Contact: Junling Li, MD 13801178891 firstname.lastname@example.org|
|Peking Union College Hospital||Recruiting|
|Contact: Wei Zhong, MD 13810616395 email@example.com|
|Study Chair:||Li Zhang, MD||Sun Yat-sen University|