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

NCT03608007 | Unknown Phase 2

• 1 other identifier: BTP-42723
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Lung Cancer; ROS1 Gene Rearrangement

Keywords

ROS1 NSCLC; X-396

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR) based on independent radiology review (IRC) according to RECIST 1.1

  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.

  12 weeks

Secondary Outcomes (9)

• ORR based on investigator assessment according to RECIST 1.1

  12 weeks

• Disease control rate (DCR) according to RECIST 1.1

  12 weeks

• Intracranial overall response rate (iORR) by IRC and investigator assessment according to RECIST 1.1

  12 weeks

• Progression-free survival (PFS) based on IRC or investigator according to RECIST 1.1

  36 months

• Time to progression (TTP) based on IRC or investigator according to RECIST 1.1

  36 months

Study Arms (1)

X-396 Capsule

EXPERIMENTAL

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

Drug: X-396 Capsule

Interventions

X-396 Capsule DRUG

225 mg once daily

Also known as: Ensartinib

X-396 Capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Betta Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Chest hospital affiliated to Shanghai jiao tong university

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

ensartinib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Shun Lu

  PHD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinxiao Xu

CONTACT

86-18610155290; jinxiao.xu@bettapharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: July 31, 2018
• Study Start: June 15, 2018
• Primary Completion: March 1, 2020
• Study Completion: September 1, 2020
• Last Updated: January 9, 2020

Record last verified: 2019-12

Locations

CN (1)