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


Betta Pharmaceuticals

Status and phase

Phase 2


Lung Cancer
ROS1 Gene Rearrangement


Drug: X-396 Capsule

Study type


Funder types




Details and patient eligibility


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.


69 estimated patients




18+ years old


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

Trial design

Primary purpose




Interventional model

Single Group Assignment


None (Open label)

69 participants in 1 patient group

X-396 Capsule
Experimental group
Single-arm trial whereby all consented, enrolled, eligible patients receive X-396 capsule, 225 mg once daily.
Drug: X-396 Capsule

Trial contacts and locations



Central trial contact

Jinxiao Xu

Data sourced from clinicaltrials.gov

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