Combination Chemotherapy With or Without Anlotinib in the Maintenance Treatment of Non-Squamous Non-Small Cell Lung Cancer.
Primary Purpose
Non-squamous Non-small-cell Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Anlotinib + Pemetrexed+Carboplatin
Pemetrexed
Anlotinib + Pemetrexed
Anlotinib
Sponsored by
About this trial
This is an interventional treatment trial for Non-squamous Non-small-cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years and ≤ 75, ECOG PS: 0~1, estimated survival duration more than 3 months;
- Subjects with histologically or cytologically confirmed locally advanced and/or advanced Non-squamous NSCLC;
- Signed and dated informed consent;
- adequate hematological, liver and renal function
Exclusion Criteria:
- prior chemotherapy or treatment with another systemic anti-cancer agent
- malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer or DCIS
- evidence of tumor invading major blood vessels
- current or recent use of aspirin (>325mg/day) or full-dose anticoagulants or thrombolytic agents for therapeutic purposes
- history of haemoptysis >/=grade 2
- clinically significant cardiovascular disease
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Experimental
Experimental
Experimental
Arm Label
First-line Treatment
Maintenance Treatment A
Maintenance Treatment B
Maintenance Treatment C
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
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Full Information
NCT ID
NCT04453423
First Posted
June 27, 2020
Last Updated
June 27, 2020
Sponsor
The First Affiliated Hospital with Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04453423
Brief Title
Combination Chemotherapy With or Without Anlotinib in the Maintenance Treatment of Non-Squamous Non-Small Cell Lung Cancer.
Official Title
A Study of the Effect of Anlotinib, Pemetrexed or the Combination As Maintenance Therapy for Patients With Non-Squamous Non-Small Cell Lung Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Anticipated)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
July 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 will compare maintenance therapy with anlotinib plus pemetrexed versus pemetrexed or anlotinib alone, in patients with Non-squamous Non-small cell lung cancer who have not progressed during first-line therapy with anlotinib + pemetrexed + carboplatin. The primary endpoint of the study is progression-free survival (PFS); the secondary endpoints are disease control rate (DCR), objective response rate (ORR) and overall survival (OS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-squamous Non-small-cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
First-line Treatment
Arm Type
Other
Arm Title
Maintenance Treatment A
Arm Type
Experimental
Arm Title
Maintenance Treatment B
Arm Type
Experimental
Arm Title
Maintenance Treatment C
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Anlotinib + Pemetrexed+Carboplatin
Intervention Description
Anlotinib: 12mg, QD, PO, d1-14, 21 days per cycle
Carboplatin: AUC 5 on day 1 of 21 days per cycle
Pemetrexed: 500mg/m2 iv on day 1 of 21 days per cycle
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
500mg/m2 iv on day 1 of 21 days per cycle(maintenance phase)
Intervention Type
Drug
Intervention Name(s)
Anlotinib + Pemetrexed
Intervention Description
Anlotinib:12mg, QD, PO, d1-14, 21 days per cycle(maintenance phase)
Pemetrexed:500mg/m2 iv on day 1 of 21 days per cycle(maintenance phase)
Intervention Type
Drug
Intervention Name(s)
Anlotinib
Intervention Description
12mg, QD, PO, d1-14, 21 days per cycle(maintenance phase)
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
Description
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:
Age ≥ 18 years and ≤ 75, ECOG PS: 0~1, estimated survival duration more than 3 months;
Subjects with histologically or cytologically confirmed locally advanced and/or advanced Non-squamous NSCLC;
Signed and dated informed consent;
adequate hematological, liver and renal function
Exclusion Criteria:
prior chemotherapy or treatment with another systemic anti-cancer agent
malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer or DCIS
evidence of tumor invading major blood vessels
current or recent use of aspirin (>325mg/day) or full-dose anticoagulants or thrombolytic agents for therapeutic purposes
history of haemoptysis >/=grade 2
clinically significant cardiovascular disease
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
Combination Chemotherapy With or Without Anlotinib in the Maintenance Treatment of Non-Squamous Non-Small Cell Lung Cancer.
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