NCT03215693

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
152

participants targeted

Target at P75+ for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started Sep 2017

Longer than P75 for phase_2 nonsmall-cell-lung-cancer

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 12, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

September 28, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2020

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

August 16, 2023

Status Verified

July 1, 2023

Enrollment Period

2.4 years

First QC Date

July 11, 2017

Last Update Submit

August 15, 2023

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • ORR based on investigator assessment

    24 months

  • Progression-free survival (PFS) as assessed by independent radiology review and investigator

    36 months

  • Overall survival (OS)

    36 months

Other Outcomes (2)

  • Overall intracranial response rate (OIRR) by independent radiology review and investigator assessment

    24 months

  • Patient reported time to deterioration (TTD) as measured by EORTC C30/LC13 QoL questionnaire

    24 months

Study Arms (1)

X-396 capsule

EXPERIMENTAL

225mg once daily

Drug: X-396 capsule

Interventions

X-396 capsuleDRUG

225mg once daily

Also known as: Ensartinib
X-396 capsule

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Beijing Cancer Hospital

Beijing, China

Location

Beijing Chest Hospital，Capital Medical University

Beijing, China

Location

Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

Peking Union College Hospital

Beijing, China

Location

Related Publications (1)

  • 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.

    PMID: 31628085DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

ensartinib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Li Zhang, MD

    Sun Yat-sen University

    STUDY CHAIR

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

July 11, 2017

First Posted

July 12, 2017

Study Start

September 28, 2017

Primary Completion

March 9, 2020

Study Completion

December 1, 2023

Last Updated

August 16, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(4)