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

Betta Pharmaceuticals

Status and phase

Unknown

Phase 2

Conditions

Lung Cancer

ROS1 Gene Rearrangement

Treatments

Drug: X-396 Capsule

Study type

Interventional

Funder types

Industry

Identifiers

NCT03608007

BTP-42723

Details and patient eligibility

About

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).

Full description

This is a phase II, multicenter, single-arm study in which the efficacy and safety of X-396 capsule (Ensartinib) will be assessed in adult Chinese patients with ROS1-positive (rearrangement or inversion) non-small cell lung cancer (NSCLC). Approximately 69 patients (59 for never-treated, and 10 for previously treated with crizotinib) with locally advanced or metastatic NSCLC carrying ROS1-rearrangement will be enrolled in the study.

Enrollment

69 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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