Back to resultsStudy of Anlotinib Hydrochloride Capsule Combined With Chemotherapy in Subjects With Squamous Non-small Cell Lung Cancer
Primary Purpose
Squamous Non-small Cell Lung Cancer
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Anlotinib
Placebos
Paclitaxel
Carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Squamous Non-small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Squamous non-small cell lung cancer.
- A measurable lesion.
- The disease progression occurs >12 months after the end of the last treatment. 4.18-75 years old ; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
5.Adequate laboratory indicators. 6.No pregnant or breastfeeding women, and a negative pregnancy test. 7.Understood and signed an informed consent form.
Exclusion Criteria:
- The tumor invades the large blood vessels.
- Central type squamous non-small cell lung cancer.
- EGFR/ALK gene mutation is positive.
- Has used EGFR inhibitors and ALK inhibitors.
- Has other malignant tumors within 5 years.
- Has a variety of factors affecting oral medications.
- Symptomatic brain metastasis.
- Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage.
- Spinal cord compression.
- Has received radiotherapy, chemotherapy, surgery less than 4 weeks before randomization.
- Severe allergies to therapeutic medications.
- Adverse events caused by previous treatment did not recover to grade 1.
- Has received major surgical treatment within 4 weeks before randomization.
- Arteriovenous thrombosis occurred within 6 months.
- Has drug abuse history that unable to abstain from or mental disorders.
- Has severe or uncontrolled disease.
- Participated in other clinical trials within 4 weeks.
- According to the investigators' judgement.
Sites / Locations
- Cancer Hospital Chinese Academy of Medical Sciences
- The Fourth Hospital of Hebei Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental group
Placebo group
Arm Description
Anlotinib hydrochloride capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) and paclitaxel 175mg/m2 D1 q3w, carboplatin AUC 5mg/mL/min D1 q3w.
Anlotinib hydrochloride placebo given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) and paclitaxel 175mg/m^2 D1 q3w, carboplatin AUC 5mg/mL/min D1 q3w.
Outcomes
Primary Outcome Measures
Progression Free Survival (PFS) evaluated by IRC
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause; IRC defined as Independent Review Committee.
Secondary Outcome Measures
Progression Free Survival (PFS) evaluated by investigator
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
Overall Survival (OS)
OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
Overall Response Rate (ORR)
Percentage of participants achieving complete response (CR) and partial response (PR).
Disease Control Rate（DCR）
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Duration of Overall Response (DOR)
The time when the patient first achieved complete or partial remission to disease progression.
PFS rate at month 6
The percentage of PFS at month 6.
PFS rate at month 12
The percentage of PFS at month 12.
OS rate at month 6
The percentage of OS at month 6.
OS rate at month 12
The percentage of OS at month 12.
OS rate at month 18
The percentage of OS at month 18.
Adverse Event (AE)
Safety data
Serious Adverse Event (SAE)
Safety data
Abnormal laboratory test index
Safety data
Full Information
NCT ID
NCT04073537
First Posted
August 26, 2019
Last Updated
August 27, 2019
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04073537
Brief Title
Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy in Subjects With Squamous Non-small Cell Lung Cancer
Official Title
A Randomized, Double-Blind, Multicenter, Phase Ⅲ Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy Versus Placebo Combined With Chemotherapy in Subjects With Squamous Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 31, 2019 (Anticipated)
Primary Completion Date
July 31, 2021 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group 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
Yes
5. Study Description
Brief Summary
Anlotinib hydrochloride is a multi-targeted receptor tyrosine kinase inhibitor that targets angiogenesis-related kinases such as VEGFR1/2/3, FGFR1/2/3, and other tumor-associated kinases involved in cell proliferation such as PDGFRα/β, c-Kit, and Ret have significant inhibitory activities.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Non-small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
386 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Anlotinib hydrochloride capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) and paclitaxel 175mg/m2 D1 q3w, carboplatin AUC 5mg/mL/min D1 q3w.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Anlotinib hydrochloride placebo given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) and paclitaxel 175mg/m^2 D1 q3w, carboplatin AUC 5mg/mL/min D1 q3w.
Intervention Type
Drug
Intervention Name(s)
Anlotinib
Intervention Description
A multi-target receptor tyrosine kinase inhibitor.
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Anlotinib blank analog capsule.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel 175 mg/m^2 IV on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin area under the concentration curve (AUC) 5 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle.
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) evaluated by IRC
Description
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause; IRC defined as Independent Review Committee.
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS) evaluated by investigator
Description
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
Time Frame
up to 24 months
Title
Overall Survival (OS)
Description
OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
Time Frame
up to 24 months
Title
Overall Response Rate (ORR)
Description
Percentage of participants achieving complete response (CR) and partial response (PR).
Time Frame
up to 24 months
Title
Disease Control Rate（DCR）
Description
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Time Frame
up to 24 months
Title
Duration of Overall Response (DOR)
Description
The time when the patient first achieved complete or partial remission to disease progression.
Time Frame
up to 24 months
Title
PFS rate at month 6
Description
The percentage of PFS at month 6.
Time Frame
up to 6 months
Title
PFS rate at month 12
Description
The percentage of PFS at month 12.
Time Frame
up to 12 months
Title
OS rate at month 6
Description
The percentage of OS at month 6.
Time Frame
up to 6 months
Title
OS rate at month 12
Description
The percentage of OS at month 12.
Time Frame
up to 12 months
Title
OS rate at month 18
Description
The percentage of OS at month 18.
Time Frame
up to 18 months
Title
Adverse Event (AE)
Description
Safety data
Time Frame
up to 24 months
Title
Serious Adverse Event (SAE)
Description
Safety data
Time Frame
up to 24 months
Title
Abnormal laboratory test index
Description
Safety data
Time Frame
up to 24 months
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:
Squamous non-small cell lung cancer.
A measurable lesion.
The disease progression occurs >12 months after the end of the last treatment. 4.18-75 years old ; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
5.Adequate laboratory indicators. 6.No pregnant or breastfeeding women, and a negative pregnancy test. 7.Understood and signed an informed consent form.
Exclusion Criteria:
The tumor invades the large blood vessels.
Central type squamous non-small cell lung cancer.
EGFR/ALK gene mutation is positive.
Has used EGFR inhibitors and ALK inhibitors.
Has other malignant tumors within 5 years.
Has a variety of factors affecting oral medications.
Symptomatic brain metastasis.
Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage.
Spinal cord compression.
Has received radiotherapy, chemotherapy, surgery less than 4 weeks before randomization.
Severe allergies to therapeutic medications.
Adverse events caused by previous treatment did not recover to grade 1.
Has received major surgical treatment within 4 weeks before randomization.
Arteriovenous thrombosis occurred within 6 months.
Has drug abuse history that unable to abstain from or mental disorders.
Has severe or uncontrolled disease.
Participated in other clinical trials within 4 weeks.
According to the investigators' judgement.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuankai Shi, Doctor
Phone
010-87788293
Email
syuankaipumc@126.com
Facility Information:
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100083
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuankai Shi, Doctor
Phone
010-87788293
Email
syuankaipumc@126.com
First Name & Middle Initial & Last Name & Degree
Yuankai Shi
Facility Name
The Fourth Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
50011
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cuimin Ding, Master
Phone
0311-86095341
Email
wjwdcm@sina.com
First Name & Middle Initial & Last Name & Degree
Cuimin Ding, Master
12. IPD Sharing Statement
Learn more about this trial
Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy in Subjects With Squamous Non-small Cell Lung Cancer
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