Back to resultsAnlotinib Combined With Nivolumab for Non-Small Cell Lung Cancer
Primary Purpose
Non Small Cell Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Anlotinib
Nivolumab
Sponsored by
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Male or female patients aged 18-75 years old;
- ECOG PS：0-1,Expected Survival Time: Over 3 months;
- Subjects with histologically or cytologically confirmed locally advanced and/or advanced NSCLC, with measurable nidus(using RECIST 1.1);
- For local advanced or advanced NSCLC, disease progression occurred after first-line systemic treatment previously;
- The negative patients in EGFR&ALK can participate or who positive in EGFR&ALK, have or have not drug tolerance after the treatment with relative targeted drugs;
- main organs function is normal;
- Signed and dated informed consent.
Exclusion Criteria:
- have used Anlotinib before;
- Small Cell Lung Cancer (including small cell cancer and other kinds of cancer mixed with non-small cell cancer);
- examined as positive in EGFR&ALK mutation detection and never take the treatment of TKIs;
- Previously (within 5 years) or presently suffering from other malignancies;
- Symptomatic or uncontrolled brain metastases;
- Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months or serious cardiac arrhythmia requiring medication;
- Pregnancy or lactation.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
anlotinib plus nivolumab
Arm Description
Outcomes
Primary Outcome Measures
Progression-Free Survival (PFS)
PFS is defined as the time from the date of treatment to the first date of disease progression or death from any cause.
Secondary Outcome Measures
Objective Response Rate (ORR)
Treatment response are defined as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to Response Evaluation Criteria in Solid Tumor (RECISIT criteria, version 1.1). The percentage of patients who achieved CR and PR was defined as objective response rate (ORR)
Disease control rate (DCR)
Treatment response are defined as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to Response Evaluation Criteria in Solid Tumor (RECISIT criteria, version 1.1) and the percentage of patients who achieved CR, PR and SD was defined as disease control rate (DCR).
Overall Survival (OS)
OS is calculated from diagnosis to death or last follow-up time.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Full Information
NCT ID
NCT04211896
First Posted
December 23, 2019
Last Updated
December 24, 2019
Sponsor
The First Affiliated Hospital with Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04211896
Brief Title
Anlotinib Combined With Nivolumab for Non-Small Cell Lung Cancer
Official Title
The Efficacy and Safety of Anlotinib Combined With Nivolumab as a Second-Line Treatment in Patients With Advanced Non-Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Anticipated)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study evaluates the safety and efficacy of anlotinib in combination with nivilumab as second-line treatment in advanced NSCLC patients. The primary endpoint of the study is progression-free survival (PFS);the secondary endpoints are disease control rate (DCR), objective response rate (ORR), overall survival (OS) and safety.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
anlotinib plus nivolumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Anlotinib
Intervention Description
Anlotinib will be given at a dose of 12mg once daily on days 1-14 of a 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Intervention Description
Nivolumab will be given at a dose of 240 mg every 2 weeks (Odd Cycles: Days 1 and 15 and Even Cycles Day 8) per 21 day Cycle.
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
PFS is defined as the time from the date of treatment to the first date of disease progression or death from any cause.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
Treatment response are defined as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to Response Evaluation Criteria in Solid Tumor (RECISIT criteria, version 1.1). The percentage of patients who achieved CR and PR was defined as objective response rate (ORR)
Time Frame
each 42 days up to intolerance the toxicity or PD (up to 12 months)
Title
Disease control rate (DCR)
Description
Treatment response are defined as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to Response Evaluation Criteria in Solid Tumor (RECISIT criteria, version 1.1) and the percentage of patients who achieved CR, PR and SD was defined as disease control rate (DCR).
Time Frame
each 42 days up to intolerance the toxicity or PD (up to 12 months)
Title
Overall Survival (OS)
Description
OS is calculated from diagnosis to death or last follow-up time.
Time Frame
12 months
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
Until 30 day safety follow-up visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients aged 18-75 years old;
ECOG PS：0-1,Expected Survival Time: Over 3 months;
Subjects with histologically or cytologically confirmed locally advanced and/or advanced NSCLC, with measurable nidus(using RECIST 1.1);
For local advanced or advanced NSCLC, disease progression occurred after first-line systemic treatment previously;
The negative patients in EGFR&ALK can participate or who positive in EGFR&ALK, have or have not drug tolerance after the treatment with relative targeted drugs;
main organs function is normal;
Signed and dated informed consent.
Exclusion Criteria:
have used Anlotinib before;
Small Cell Lung Cancer (including small cell cancer and other kinds of cancer mixed with non-small cell cancer);
examined as positive in EGFR&ALK mutation detection and never take the treatment of TKIs;
Previously (within 5 years) or presently suffering from other malignancies;
Symptomatic or uncontrolled brain metastases;
Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months or serious cardiac arrhythmia requiring medication;
Pregnancy or lactation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Renhua Guo, MD
Phone
025-68136360
Email
rhguo@njmu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Anlotinib Combined With Nivolumab for Non-Small Cell Lung Cancer
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