search
Back to results

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

Primary Purpose

ALK-positive Non-small Cell Lung Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Alkotinib Capsules
Sponsored by
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ALK-positive Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • At least one measurable lension by response evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1).
  • Willingness and ability to comply with the trial and follow-up procedures.

Exclusion Criteria:

  • chemotherapy, radiation therapy, immunotherapy within 4 weeks.
  • Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications.
  • Uncontrolled mass of pleural effusion, pericardial effusion, and peritoneal effusion

Sites / Locations

  • Shanghai Pulmonary HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Alkotinib 400mg QD

Arm Description

400mg orally once daily. Take Alkotinib at least 1 hour before or at least 2 hours after a meal.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Progression-free survival (PFS) as assessed by independent radiology review and investigator
PFS, defined as time from first dose of Alkotinib to progression or death due to any cause.
Overall survival (OS)
OS, defined as time from first dose of Alkotinib to death due to any cause

Full Information

First Posted
December 23, 2019
Last Updated
October 22, 2023
Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT04211922
Brief Title
Alkotinib Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib
Official Title
A Phase II, Multicenter, Single-arm Study to Evaluate Safety and Efficacy of Alkotinib Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 21, 2020 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main purpose of the study is to evaluate safety and efficacy of Alkotinib 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.
Detailed Description
The drug being tested in this study is called alkotinib. Alkotinib has been demonstrated to benefit people with ALK+ NSCLC. The study is a non-control study. The study will enroll approximately 104 participants. All participants will take alkotinib 300mg throughout the study. This multi-center trial will be conducted in China. The overall time to participate in this study is 3 years. Participants will make multiple visits to the site, and 28 days after last dose of study drug for a follow-up assessment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ALK-positive Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alkotinib 400mg QD
Arm Type
Experimental
Arm Description
400mg orally once daily. Take Alkotinib at least 1 hour before or at least 2 hours after a meal.
Intervention Type
Drug
Intervention Name(s)
Alkotinib Capsules
Other Intervention Name(s)
ZG0418
Intervention Description
Alkotinib 400mg QD
Primary Outcome Measure Information:
Title
Objective response rate (ORR) based on independent radiology review
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).
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS) as assessed by independent radiology review and investigator
Description
PFS, defined as time from first dose of Alkotinib to progression or death due to any cause.
Time Frame
36 months
Title
Overall survival (OS)
Description
OS, defined as time from first dose of Alkotinib to death due to any cause
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 At least one measurable lension by response evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1). Willingness and ability to comply with the trial and follow-up procedures. Exclusion Criteria: chemotherapy, radiation therapy, immunotherapy within 4 weeks. Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications. Uncontrolled mass of pleural effusion, pericardial effusion, and peritoneal effusion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caicun Zhou, Dr.
Phone
021-65115006
Ext
1027
Email
caicunzhoudr@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bangyu Zhang
Phone
021-65115006
Ext
1027
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caicun Zhou, Doctor
Organizational Affiliation
Shanghai Pulmonary Hospital, Shanghai, China
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caicun Zhou, Doctor
Phone
021-65115006
Email
caicunzhoudr@163.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs