X-396 Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib

A Phase II, Multicenter, Single-arm Study to Evaluate Safety and Efficacy of X-396 Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib

The main purpose of the study is to evaluate safety and efficacy of X-396(Ensartinib) capsule in patients with ALK-positive non-small cell lung cancer previously treated with crizotinib.While exploring the relationship between biomarkers and drug efficacy and safety.

Study Overview

• Status: Active, not recruiting
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: X-396 capsule

Detailed Description

This is a phase II, multicenter, single-arm study in which the safety and efficacy of X-396(Ensartinib) will be assessed in adult Chinese patients with ALK-positive(rearrangement) non-small cell lung cancer previously treated with crizotinib. Approximately 144 patients with locally advanced or metastatic NSCLC which carry ALK -rearrangement will be enrolled in the study.

• Study Type: Interventional
• Enrollment (Estimated): 152
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Cancer Hospital
  • Beijing, China
    • Beijing Chest Hospital,Capital Medical University
  • Beijing, China
    • Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences
  • Beijing, China
    • Peking Union College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically or cytologically confirmed diagnosis of metastatic non-small cell lung cancer.
• Evidence of positive ALK.
• Patients must have demonstrated progression during or after crizotinib treatment.
• Age 18 years or older at the time of informed consent.
• Eastern cooperative oncology group performance status (ECOG PS) of 0-2
• Measurable disease by response evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1).
• Asymptomatic CNS metastases do not require the use of steroids or anticonvulsants.
• Willingness and ability to comply with the trial and follow-up procedures.
• Ability to understand the nature of this trial and give written informed consent.

Exclusion Criteria:

• Prior use of ALK TKIs with the exception of crizotinib.
• Patients currently receiving cancer system therapy.
• Use of an investigational drug within 4 weeks prior to the first dose of study drug.
• Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications.
• Patients with a known allergy or delayed hypersensitivity reaction to drugs.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: X-396 capsule; 225mg once daily	Drug: X-396 capsule; 225mg once daily; Other Names: Ensartinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR) based on independent radiology review	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).	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR based on investigator assessment	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).	24 months
Progression-free survival (PFS) as assessed by independent radiology review and investigator	PFS, defined as time from first dose of X-396 to progression or death due to any cause.	36 months
Overall survival (OS)	OS, defined as time from first dose of X-396 to death due to any cause.	36 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall intracranial response rate (OIRR) by independent radiology review and investigator assessment	OIRR calculated as the ORR (CR+PR) of lesions in the brain for patients who have measureable disease in the brain at baseline.	24 months
Patient reported time to deterioration (TTD) as measured by EORTC C30/LC13 QoL questionnaire	Time to deterioration (TTD) is defined at the time from date of randomization to a worsening of at least 10 points (on a 100 point scale) in each item score of the EORTC C30/LC13	24 months

Collaborators and Investigators

• Sponsor: Betta Pharmaceuticals Co., Ltd.
• Investigators: Study Chair: Li Zhang, MD, Sun Yat-sen University

Publications and helpful links

General Publications

• Yang Y, Zhou J, Zhou J, Feng J, Zhuang W, Chen J, Zhao J, Zhong W, Zhao Y, Zhang Y, Song Y, Hu Y, Yu Z, Gong Y, Chen Y, Ye F, Zhang S, Cao L, Fan Y, Wu G, Guo Y, Zhou C, Ma K, Fang J, Feng W, Liu Y, Zheng Z, Li G, Wu N, Song W, Liu X, Zhao S, Ding L, Mao L, Selvaggi G, Yuan X, Fu Y, Wang T, Xiao S, Zhang L. Efficacy, safety, and biomarker analysis of ensartinib in crizotinib-resistant, ALK-positive non-small-cell lung cancer: a multicentre, phase 2 trial. Lancet Respir Med. 2020 Jan;8(1):45-53. doi: 10.1016/S2213-2600(19)30252-8. Epub 2019 Oct 15.

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2017
• Primary Completion (Actual): March 9, 2020
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: July 11, 2017
• First Submitted That Met QC Criteria: July 11, 2017
• First Posted (Actual): July 12, 2017

Study Record Updates

• Last Update Posted (Actual): August 16, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Ensartinib
• Other Study ID Numbers: BTP-42322

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No