Back to resultsAnlotinib Plus Pemetrexed or Pemetrexed for Previously Untreated Elderly (>=70) or PS=2 Non-squamous NSCLC
Primary Purpose
Advanced Non-squamous NSCLC
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Anlotinib plus Pemetrexed
Pemetrexed
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Non-squamous NSCLC
Eligibility Criteria
Inclusion Criteria:
- ≥70 years old and ECOG PS=0-2 or ≥18 years old and ECOG PS=2
- Diagnosed with advanced or recurrent non-squamous NSCLC (phase IIIB/IV) through pathology, with measurable nidus(using RECIST 1.1)
- No prior systemic treatment for non-squamous NSCLC
- Negative in EGFR&ALK&ROS1
- Main organs function is normal
Exclusion Criteria:
- Have any habitus or medical history of hemorrhage, however severe it is; the patients who have non healing wounds, ulcer or fracture after any events with hemorrhage or bleeding
- Symptoms of brain metastases cannot be controlled and treated within less than 21 days
- Have participated in other clinical trials of anti-tumor medicine within 4 weeks
- Get any severe diseases or the ones that cannot be controlled
Sites / Locations
- Beijing Chest HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Anlotinib plus Pemetrexed
Pemetrexed
Arm Description
Anlotinib plus Pemetrexed
Pemetrexed
Outcomes
Primary Outcome Measures
Proportion of patients alive and progression free at 6 months (APF6)
the number (%) of patients who are alive and progression free per RECIST 1.1 at 6 months after randomization per Kaplan-Meier estimate of progression free survival at 6 months.
Secondary Outcome Measures
Progression Free Survival(PFS)
the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)
Overall Survival(OS)
the time from randomization to death from any cause
Disease Control Rate(DCR)
the total proportion of patients who demonstrate a response(complete responses + partial responses + stable disease ) to treatment
Objective Response Rate(ORR)
the total proportion of patients who demonstrate a response(complete responses + partial responses) to treatment
Full Information
NCT ID
NCT03768037
First Posted
November 30, 2018
Last Updated
December 5, 2018
Sponsor
Guangdong Association of Clinical Trials
1. Study Identification
Unique Protocol Identification Number
NCT03768037
Brief Title
Anlotinib Plus Pemetrexed or Pemetrexed for Previously Untreated Elderly (>=70) or PS=2 Non-squamous NSCLC
Official Title
A Study to Evaluate the Efficacy and Safety of Anlotinib Plus Pemetrexed as the 1-line Treatment of Patients With Platinum Intolerant Advanced Non-squamous NSCLC, With Pemetrexed Control.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 26, 2018 (Anticipated)
Primary Completion Date
November 26, 2019 (Anticipated)
Study Completion Date
November 26, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangdong Association of Clinical Trials
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
Evaluate the efficacy and safety of Anlotinib plus Pemetrexed as the 1-line treatment of patients with Platinum intolerant advanced non-squamous NSCLC, with Pemetrexed control.
Detailed Description
Anlotinib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR1、VEGFR2、VEGFR3、FGFR1/2/3、PDGFRa/β c-Kit and MET.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Non-squamous NSCLC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anlotinib plus Pemetrexed
Arm Type
Experimental
Arm Description
Anlotinib plus Pemetrexed
Arm Title
Pemetrexed
Arm Type
Other
Arm Description
Pemetrexed
Intervention Type
Drug
Intervention Name(s)
Anlotinib plus Pemetrexed
Intervention Description
Anlotinib p.o, qd and it should be continued until disease progress or unacceptable toxic effects.
Pemetrexed 500 mg/m2 every 21 days for 4-6 cycles or unacceptable toxic effects
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Pemetrexed 500 mg/m2 every 21 days for 4-6 cycles or unacceptable toxic effects
Primary Outcome Measure Information:
Title
Proportion of patients alive and progression free at 6 months (APF6)
Description
the number (%) of patients who are alive and progression free per RECIST 1.1 at 6 months after randomization per Kaplan-Meier estimate of progression free survival at 6 months.
Time Frame
Estimated to be from baseline up to 2 years
Secondary Outcome Measure Information:
Title
Progression Free Survival(PFS)
Description
the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)
Time Frame
Estimated to be from baseline up to 2 years
Title
Overall Survival(OS)
Description
the time from randomization to death from any cause
Time Frame
Estimated to be from baseline up to 2 years
Title
Disease Control Rate(DCR)
Description
the total proportion of patients who demonstrate a response(complete responses + partial responses + stable disease ) to treatment
Time Frame
Estimated to be from baseline up to 2 years
Title
Objective Response Rate(ORR)
Description
the total proportion of patients who demonstrate a response(complete responses + partial responses) to treatment
Time Frame
Estimated to be from baseline up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥70 years old and ECOG PS=0-2 or ≥18 years old and ECOG PS=2
Diagnosed with advanced or recurrent non-squamous NSCLC (phase IIIB/IV) through pathology, with measurable nidus(using RECIST 1.1)
No prior systemic treatment for non-squamous NSCLC
Negative in EGFR&ALK&ROS1
Main organs function is normal
Exclusion Criteria:
Have any habitus or medical history of hemorrhage, however severe it is; the patients who have non healing wounds, ulcer or fracture after any events with hemorrhage or bleeding
Symptoms of brain metastases cannot be controlled and treated within less than 21 days
Have participated in other clinical trials of anti-tumor medicine within 4 weeks
Get any severe diseases or the ones that cannot be controlled
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoqing Liu
Phone
86-010-89509324
Email
liuxiaoqing@csco.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Shucai Zhang
Phone
86-010-89509324
Email
sczhang6304@163.com
Facility Information:
Facility Name
Beijing Chest Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101149
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shucai Zhang
Phone
86-010-89509324
Email
sczhang6304@163.com
First Name & Middle Initial & Last Name & Degree
Zhe Liu
Phone
86-010-89509323
Email
liuzhe1968@aliyun.com
12. IPD Sharing Statement
Learn more about this trial
Anlotinib Plus Pemetrexed or Pemetrexed for Previously Untreated Elderly (>=70) or PS=2 Non-squamous NSCLC
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