Clinical trial · Interventional
X-396 Capsule in Advanced NSCLC Patients With ROS1 Gene Rearrangement
Phase II, Open-Label, Single Arm Study of the Efficacy and Safety of X-396 Capsule in Patients With ROS1 Positive Advanced NSCLC
NCT03608007CI-TRIAL-00042663unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| ROS1 Gene Rearrangement | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| X-396 Capsule | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- X-396 Capsule
- description
- Single-arm trial whereby all consented, enrolled, eligible patients receive X-396 capsule, 225 mg once daily.
- interventionNames
- Drug: X-396 Capsule
Primary outcomes (1)
- measure
- Objective response rate (ORR) based on independent radiology review (IRC) according to RECIST 1.1
- timeFrame
- 12 weeks
- description
- 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.
Secondary outcomes (9)
- measure
- ORR based on investigator assessment according to RECIST 1.1
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.