X-396 Capsule in Advanced NSCLC Patients With ROS1 Gene Rearrangement

• Status: Recruiting
• Trial end date: 2020-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.; Betta Pharmaceuticals Co.,Ltd.
• Treatments: Ensartinib

Criteria

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