Back to resultsA Study of Lobaplatin/Etoposide With or Without Anlotinib Maintenance Therapy in Patients With ES-SCLC
Primary Purpose
Small Cell Lung Carcinoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Anlotinib Hydrochloride
Lobaplatin
Etoposide
Sponsored by
About this trial
This is an interventional treatment trial for Small Cell Lung Carcinoma focused on measuring extensive-stage small-cell lung cancer, lobaplatin/etoposide, Anlotinib maintenance therapy
Eligibility Criteria
Inclusion Criteria:
- Histopathologically confirmed patients with extensive small cell lung cancer;
- Karnofsky performance status ≥70;
- At least one lesion that can measured by CT;
- Expected to survive for at least 3 months;
Peripheral blood and liver and kidney function within the following allowable range (tested within 7 days before treatment);
- White blood cell (WBC) ≥3.0×109/L or Neutrophils (ANC) ≥1.5×109/L;
- Hemoglobin (HGB) ≥80 g/L；
- Platelet (PLT) ≥100×109/L;
- Liver transaminases（AST/ALT）<3.0 times the normal range limit;
- Total bilirubin（TBIL）<1.5 times the normal range limit;
- Creatinine（CREAT）<1.5 times the normal range limit;
- Patients of childbearing age (including female and male patients' partner) must take effective contraception methods;
- Signed informed consent;
- Known history of liver disease: Hepatitis B Virus (HBV) infection and Hepatitis B Virus DNA (HBV DNA ≥500 copies or ≥100 IU/ml); or Hepatitis C Virus (HCV) infection; or liver cirrhosis, etc.
- Human immunodeficiency virus (HIV);
- Subjects with difficulties in swallowing or known drug malabsorption; Those who meet each of the above criteria are included in the study.
Exclusion Criteria:
- Other pathological types of tumor except for small cell lung cancer;
- Patients with a history of severe allergies or allergies;
- Pregnancy or breastfeeding women;
- Patients who have previously participated in other clinical trials and have not yet terminated the trial;
- Combined with other tumors at the time of initial diagnosis;
- Patients who have previously participated in other clinical trials and have not yet terminated the trial;
- Patients who have acute infection that difficult to control;
- Drug abuse, substance abuse, chronic alcohol abuse, and AIDS patients. Those who meet any of the above criteria are not included in the study.
Sites / Locations
- The First Affiliated Hospital of Guangzhou Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Anlotinib/Lobaplatin/Etoposide
Lobaplatin/Etoposide
Arm Description
EL regimen for 4 cycles followed by Anlotinib Hydrochloride maintenance therapy
EL regimen for 4 cycles
Outcomes
Primary Outcome Measures
Progression Free Survival Time
Progression free survival (PFS) is defined as the time from date of randomization to the date of objective disease progression or death due to any cause. Participants were censored at date of last PFS assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy, whichever was earlier.
Secondary Outcome Measures
Percentage of Participants With a Complete Response (CR) and Partial Response (PR) (Overall Response Rate)
Overall Response Rate (ORR) is the number of participants with a Complete Response (CR) and Partial Response (PR) divided by the total number of randomized participants per arm, then multiplied by 100. Response is based on the Response Evaluation Criteria In Solid Tumors (RECIST 1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions. Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions compared to baseline or the complete disappearance of target lesions, with persistence of 1 or more nontarget lesion(s) and no new lesions.
Overall Survival
Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.
Full Information
NCT ID
NCT03700359
First Posted
July 29, 2018
Last Updated
November 26, 2019
Sponsor
The First Affiliated Hospital of Guangzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03700359
Brief Title
A Study of Lobaplatin/Etoposide With or Without Anlotinib Maintenance Therapy in Patients With ES-SCLC
Official Title
A Randomized, Open-label Study of Lobaplatin/Etoposide as First Line Therapy With or Without Anlotinib Maintenance Therapy in Patients With Extensive-stage Small-cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
November 29, 2020 (Anticipated)
Study Completion Date
November 29, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Guangzhou Medical University
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 is a prospective, randomized, open-label and active controlled phase II study. It plans to enroll 60 subjects with extensive stage small cell lung cancer (ES-SCLC). All subjects will be assigned randomly to the experimental arm or control arm. The primary endpoints would be overall survival and progression-free survival.
Detailed Description
Small cell lung cancer (SCLC) accounts for about 20% of lung cancer, has a high degree of malignancy, short doubling time, early and widespread metastasis, is sensitive to chemotherapy and radiotherapy, and has a high initial response rate, but is prone to secondary drug resistance and relapse. The treatment is mainly based on systemic chemotherapy.
SCLC has a more abundant vascular network than NSCLC. Anti-tumor vascular therapy combined with chemotherapy is considered the most promising SCLC first-line anti-tumor strategy. Anlotinib Hydrochloride has an anti-angiogenic effect and inhibits tumor's growth. It has been reported that Anlotinib has the dual benefits of both overall survival and progression-free survival in the treatment of multiple tumors, and has initially demonstrated its safety and efficacy. The ALTER 0303 study results showed that Anlotinib benefited both the overall and progression-free survival of NSCLC patients. However, there is no clinical study to probe its relevance to small cell lung cancer, and few studies have examined the status of Anlotinib in first-line treatment.
This randomized, open-label, controlled study is to evaluate the efficacy and safety of sequential EL regimen with Anlotinib hydrochloride as first-line treatment for extensive-stage SCLC. The study plan to enroll 60 ES-SCLC subjects and will provide evidence for the use of Anlotinib for SCLC first-line treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Carcinoma
Keywords
extensive-stage small-cell lung cancer, lobaplatin/etoposide, Anlotinib maintenance therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anlotinib/Lobaplatin/Etoposide
Arm Type
Experimental
Arm Description
EL regimen for 4 cycles followed by Anlotinib Hydrochloride maintenance therapy
Arm Title
Lobaplatin/Etoposide
Arm Type
Active Comparator
Arm Description
EL regimen for 4 cycles
Intervention Type
Drug
Intervention Name(s)
Anlotinib Hydrochloride
Other Intervention Name(s)
AL3818
Intervention Description
Anlotinib: Maintenance therapy 12mg/day P.O., day 1-15 every 21 days (2 weeks on, 1 week off) until progressive disease or treatment discontinuation
Intervention Type
Drug
Intervention Name(s)
Lobaplatin
Other Intervention Name(s)
D-19466
Intervention Description
Lobaplatin:30 mg/m2 IV every 21 days for up to 4 cycles of 21 days
Intervention Type
Drug
Intervention Name(s)
Etoposide
Other Intervention Name(s)
VP16
Intervention Description
Etoposide: 60 mg/m2 IV every 21 days for up to 4 cycles of 21 days
Primary Outcome Measure Information:
Title
Progression Free Survival Time
Description
Progression free survival (PFS) is defined as the time from date of randomization to the date of objective disease progression or death due to any cause. Participants were censored at date of last PFS assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy, whichever was earlier.
Time Frame
Time from randomization to first documented progression, assessed for up to 2 years
Secondary Outcome Measure Information:
Title
Percentage of Participants With a Complete Response (CR) and Partial Response (PR) (Overall Response Rate)
Description
Overall Response Rate (ORR) is the number of participants with a Complete Response (CR) and Partial Response (PR) divided by the total number of randomized participants per arm, then multiplied by 100. Response is based on the Response Evaluation Criteria In Solid Tumors (RECIST 1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions. Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions compared to baseline or the complete disappearance of target lesions, with persistence of 1 or more nontarget lesion(s) and no new lesions.
Time Frame
Up to 2 years
Title
Overall Survival
Description
Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.
Time Frame
Time from randomization to death by any cause, assessed for up to 3 years
Other Pre-specified Outcome Measures:
Title
Percentage of Participants Experiencing an Adverse Event (AE)
Description
An AE is defined as any untoward medical occurrence in a participant administered study treatment which does not necessarily have to have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure
Time Frame
Up to 2 years
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:
Histopathologically confirmed patients with extensive small cell lung cancer;
Karnofsky performance status ≥70;
At least one lesion that can measured by CT;
Expected to survive for at least 3 months;
Peripheral blood and liver and kidney function within the following allowable range (tested within 7 days before treatment);
White blood cell (WBC) ≥3.0×109/L or Neutrophils (ANC) ≥1.5×109/L;
Hemoglobin (HGB) ≥80 g/L；
Platelet (PLT) ≥100×109/L;
Liver transaminases（AST/ALT）<3.0 times the normal range limit;
Total bilirubin（TBIL）<1.5 times the normal range limit;
Creatinine（CREAT）<1.5 times the normal range limit;
Patients of childbearing age (including female and male patients' partner) must take effective contraception methods;
Signed informed consent;
Known history of liver disease: Hepatitis B Virus (HBV) infection and Hepatitis B Virus DNA (HBV DNA ≥500 copies or ≥100 IU/ml); or Hepatitis C Virus (HCV) infection; or liver cirrhosis, etc.
Human immunodeficiency virus (HIV);
Subjects with difficulties in swallowing or known drug malabsorption; Those who meet each of the above criteria are included in the study.
Exclusion Criteria:
Other pathological types of tumor except for small cell lung cancer;
Patients with a history of severe allergies or allergies;
Pregnancy or breastfeeding women;
Patients who have previously participated in other clinical trials and have not yet terminated the trial;
Combined with other tumors at the time of initial diagnosis;
Patients who have previously participated in other clinical trials and have not yet terminated the trial;
Patients who have acute infection that difficult to control;
Drug abuse, substance abuse, chronic alcohol abuse, and AIDS patients. Those who meet any of the above criteria are not included in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiexia Zhang, MD, PhD
Phone
86 20 83062830
Email
drzjxcn@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiexia Zhang
Organizational Affiliation
The First Affiliated Hospital of Guangzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiexia Zhang, prof.
Phone
13903056432
Email
drzjxcn@126.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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A Study of Lobaplatin/Etoposide With or Without Anlotinib Maintenance Therapy in Patients With ES-SCLC
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