Lung Cancer Clinical Trial
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
To assess treatment effectiveness and safety of oral X-396 capsule (Ensartinib) administered to Chinese patients with Advanced Non-Small Cell Lung Cancer (NSCLC) that is confirmed to be positive for a c-ROS Oncogene (ROS1) positive gene mutation (translocation or inversion).
Status | Recruiting |
Enrollment | 69 |
Est. completion date | September 2020 |
Est. primary completion date | March 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Female or male, 18 years of age or older - Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic - Positive for translocation or inversion events involving the ROS1 gene - Tyrosine kinase inhibitor (TKI) treatment-naive or have previously received no more than one systemic treatment regimen(s) such as chemotherapy (After a 3-week washout period) - Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 - Predicted survival = 3 months - Drug related toxicities were relieved to grade 1, except for hair loss (based on NCI CTCAE v4.03) - Adequate organ function - At least 1 measurable tumor lesion as per RECIST v1.1 - Asymptomatic central nervous system (CNS) metastases do not require the use of steroids or anticonvulsants. - Signed and dated informed consent - Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures - Agree to use effective contraception during the study period and for at least 90 days after completion of the study treatment Exclusion Criteria: - Current treatment on another systemic anti-cancer therapy - Prior therapy specifically directed against ROS1 fusion genes (except for the exploratory arm that will enroll patients pretreated with crizotinib) - Evidence of active malignancy within last 3 years - Previous therapeutic clinical trial must have completed at least 4 week prior to initiation of study drug - Prior surgery or immunotherapy must have completed at least 4 weeks, and radiation must have been completed at least 2 weeks prior to initiation of study drug - Known interstitial fibrosis or interstitial lung disease - Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medication - Clinically significant cardiovascular disease - Patients with a known allergy or delayed hypersensitivity reaction to study drug or its excipient - Pregnant or breast feeding - Use of drugs or foods that are known potent CYP3A4 inhibitors or inducers - Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol - Other serious illness or medical condition potentially interfering with the study |
Country | Name | City | State |
---|---|---|---|
China | Chest hospital affiliated to Shanghai jiao tong university | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Betta Pharmaceuticals Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective response rate (ORR) based on independent radiology review (IRC) according to RECIST 1.1 | 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. | 12 weeks | |
Secondary | ORR based on investigator assessment according to RECIST 1.1 | 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 | 12 weeks | |
Secondary | Disease control rate (DCR) according to RECIST 1.1 | 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 | 12 weeks | |
Secondary | Intracranial overall response rate (iORR) by IRC and investigator assessment according to RECIST 1.1 | iORR calculated as the ORR (CR+PR) of lesions in the brain for patients who have measurable disease in the brain at baseline. | 12 weeks | |
Secondary | Progression-free survival (PFS) based on IRC or investigator according to RECIST 1.1 | 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. | 36 months | |
Secondary | Time to progression (TTP) based on IRC or investigator according to RECIST 1.1 | TTP defined as time from first dose of X-396 capsule to disease progression, based on RECIST 1.1. | 36 months | |
Secondary | Duration of response (DOR) based on IRC or investigator according to RECIST 1.1 | DOR defined as time from documentation of tumor response (CR or PR) to disease progression or death, based on RECIST 1.1 | 36 months | |
Secondary | Overall survival (OS) | OS, defined as time from first dose of X-396 to death due to any cause. | 36 months | |
Secondary | Change From Baseline Scores on the functional assessment of cancer therapy - Lung (FACT-L) quality of life questionnaire | 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). | 36 months | |
Secondary | Incidence of patients experiencing adverse events (AE) | Adverse events are graded according to CTCAE 4.03 | 36 months |
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