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

Non-Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03215693
• Other study ID #: BTP-42322
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 28, 2017
• Est. completion date: December 2023

Study information

• Verified date: July 2023
• Source: Betta Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 152
• Est. completion date: December 2023
• Est. primary completion date: March 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• X-396 capsule
225mg once daily

Locations

Country	Name	City	State
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	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Betta Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	Overall survival (OS)	OS, defined as time from first dose of X-396 to death due to any cause.	36 months