x-396 capsule in advanced nsclc patients with ros1 gene rearrangement

Conditions: Lung Cancer; ROS1 Gene Rearrangement

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).

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.

Eligibility 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

Keywords: ros1 nsclc x-396