Back to resultsTo Evaluate the Efficacy and Safety of Anlotinib Combined With Allitinib in Lung Cancer
Primary Purpose
Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Anlotinib Hydrochloride Capsule Combined with Allitinib Tablets
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Locally advanced and/or metastatic NSCLC diagnosed histologically and/or cytologically;
- Age 18 and above; Eastern Cooperative Oncology Group Physical condition: 0~1; The expected survival time is more than 3 months;
Patients must present with a previously reported exon deletion mutation of Epidermal Growth Factor Receptor 19 .
The investigator confirmed that the report could reflect the patient's current genetic status.
- There is at least one measurable lesion other than brain lesion defined by Response Evaluation Criteria In Solid Tumors 1.1 standard;
- The main organs are functioning well,Adequate laboratory indicators.
- Women of childbearing age should agree to use contraceptives during the study period and for a period of six months after the study; Negative serum or urine pregnancy test within 7 days prior to study inclusion, and must be non-lactating; Male patients should agree to use contraception during the study period and for six months after the end of the study period;
- Patients voluntarily participated in this study, signed informed consent, and had good compliance.
Exclusion Criteria:
- Prior history of targeted Epidermal Growth Factor Receptor therapy and anti-angiogenic drugs
- Received chemical or biological drugs after the diagnosis of advanced stage;
- Subjects had undergone surgery , radiation therapy or other anticancer therapies within 4 weeks prior to the commencement of study treatment; Subjects who have previously received local radiation therapy may be enrolled if the following conditions are met: more than 4 weeks after the end of radiation therapy ;
- Within 2 weeks before the start of the study, patients were treated with Chinese medicines
- Imaging shows that the tumor has invaded the periphery of important blood vessels or the investigator has determined that the tumor is very likely to invade important blood vessels and cause fatal bleeding during the follow-up study.
- Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage ;
- Brain metastases with symptoms or symptom control time less than 2 weeks;
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Anlotinib Hydrochloride Capsule Combined with Allitinib Tablets
Arm Description
Anlotinib Hydrochloride Capsule: Oral on an empty stomach, once a day, 1 capsule each time, orally for 2 consecutive weeks, stop for 1 week Allitinib Tablets：The dose of allitinib mesylate is 80 mg once a day, 2 tablets each time, taken orally on an empty stomach before breakfast. Take medicine continuously for 3 weeks (21 days) for 1 cycle.
Outcomes
Primary Outcome Measures
Safety and Efficacy of drug therapy
The probability and severity of first cycle adverse events (AE) and serious adverse events (SAE) (based on Common Terminology Criteria for Adverse Events 5.0) and abnormal laboratory test indicators;
Secondary Outcome Measures
The overall efficacy was assessed by the investigators
Objective response rate (ORR) assessed by the investigators
Full Information
NCT ID
NCT04671303
First Posted
November 30, 2020
Last Updated
December 11, 2020
Sponsor
Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04671303
Brief Title
To Evaluate the Efficacy and Safety of Anlotinib Combined With Allitinib in Lung Cancer
Official Title
This Study is To Evaluate the Efficacy and Safety of Anlotinib Hydrochloride Capsule Combined With Allitinib Tablets in First-line Treatment of Advanced No-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Anticipated)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
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
This Study is To Evaluate the Efficacy and Safety of Anlotinib Hydrochloride Capsule Combined with Allitinib Tablets in First-line Treatment of Advanced no-squamous and No-small Cell Lung Cancer with Epidermal Growth Factor Receptor Mutation.
Detailed Description
This Study is To Evaluate the Efficacy and Safety of Anlotinib Hydrochloride Capsule Combined with Allitinib Tablets in First-line Treatment of Advanced No-squamous and No-small Cell Lung Cancer with Epidermal Growth Factor Receptor Mutation.
This study is a single arm, phase II study, including 18 to 36 subjects; Common Terminology Criteria for Adverse Events 5.0 standard was used to evaluate adverse events of drugs, and Response Evaluation Criteria In Solid Tumors 1.1 was used to evaluated efficacy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anlotinib Hydrochloride Capsule Combined with Allitinib Tablets
Arm Type
Experimental
Arm Description
Anlotinib Hydrochloride Capsule: Oral on an empty stomach, once a day, 1 capsule each time, orally for 2 consecutive weeks, stop for 1 week Allitinib Tablets：The dose of allitinib mesylate is 80 mg once a day, 2 tablets each time, taken orally on an empty stomach before breakfast.
Take medicine continuously for 3 weeks (21 days) for 1 cycle.
Intervention Type
Drug
Intervention Name(s)
Anlotinib Hydrochloride Capsule Combined with Allitinib Tablets
Intervention Description
Anlotinib Hydrochloride Capsule: Oral on an empty stomach, once a day, 1 capsule each time, orally for 2 consecutive weeks, stop for 1 week Allitinib Tablets：The dose of allitinib mesylate is 80 mg once a day, 2 tablets each time, taken orally on an empty stomach before breakfast.
Take medicine continuously for 3 weeks (21 days) for 1 cycle.
Primary Outcome Measure Information:
Title
Safety and Efficacy of drug therapy
Description
The probability and severity of first cycle adverse events (AE) and serious adverse events (SAE) (based on Common Terminology Criteria for Adverse Events 5.0) and abnormal laboratory test indicators;
Time Frame
up to 4 weeks
Secondary Outcome Measure Information:
Title
The overall efficacy was assessed by the investigators
Description
Objective response rate (ORR) assessed by the investigators
Time Frame
up to 48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Locally advanced and/or metastatic NSCLC diagnosed histologically and/or cytologically;
Age 18 and above; Eastern Cooperative Oncology Group Physical condition: 0~1; The expected survival time is more than 3 months;
Patients must present with a previously reported exon deletion mutation of Epidermal Growth Factor Receptor 19 .
The investigator confirmed that the report could reflect the patient's current genetic status.
There is at least one measurable lesion other than brain lesion defined by Response Evaluation Criteria In Solid Tumors 1.1 standard;
The main organs are functioning well,Adequate laboratory indicators.
Women of childbearing age should agree to use contraceptives during the study period and for a period of six months after the study; Negative serum or urine pregnancy test within 7 days prior to study inclusion, and must be non-lactating; Male patients should agree to use contraception during the study period and for six months after the end of the study period;
Patients voluntarily participated in this study, signed informed consent, and had good compliance.
Exclusion Criteria:
Prior history of targeted Epidermal Growth Factor Receptor therapy and anti-angiogenic drugs
Received chemical or biological drugs after the diagnosis of advanced stage;
Subjects had undergone surgery , radiation therapy or other anticancer therapies within 4 weeks prior to the commencement of study treatment; Subjects who have previously received local radiation therapy may be enrolled if the following conditions are met: more than 4 weeks after the end of radiation therapy ;
Within 2 weeks before the start of the study, patients were treated with Chinese medicines
Imaging shows that the tumor has invaded the periphery of important blood vessels or the investigator has determined that the tumor is very likely to invade important blood vessels and cause fatal bleeding during the follow-up study.
Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage ;
Brain metastases with symptoms or symptom control time less than 2 weeks;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuankai S, Doctor
Phone
010-87788268
Email
medart@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuankai S, Doctor
Organizational Affiliation
Chinese Academy of Medical Sciences and Peking Union Medical College
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
To Evaluate the Efficacy and Safety of Anlotinib Combined With Allitinib in Lung Cancer
We'll reach out to this number within 24 hrs