Back to resultsS1 Plus Anlotinib in Treating Patients With Refractory or Relapsed Small-cell Lung Cancer
Primary Purpose
Small Cell Lung Cancer Recurrent
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
S1/Anlotinib
Sponsored by
About this trial
This is an interventional treatment trial for Small Cell Lung Cancer Recurrent
Eligibility Criteria
Inclusion Criteria:
- Histological or cytologically confirmed small cell lung cancer;
- Systemic chemotherapy that has previously received at least one or more lines regimen, followed by disease progression or recurrence;
- Age 18-75 years,ECOG PS:0-2,Life expectancy of more than 3 months
- participants had at least one measurable target lesion by RECIST1.1
- The main organ function meets the following criteria:absolute value of neutrophils ≥ 1.5 × 109 / L, platelets ≥80 × 109 / L, hemoglobin ≥ 80 g / L;total bilirubin ≤ 1.5 times the upper limit of normal value, aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times the upper limit of normal value (if liver metastasis, ≤ upper limit of normal value 5 times), serum creatinine ≤ 1.5 times the upper limit of normal;
- Patients should participate in the study voluntarily and sign informed consent
Exclusion Criteria:
- Patients who have been used anti-angiogenesis inhibitors,such as (such as sunitinib,bevacizumab,endostar et al.
- Subjects with symptomatic brain metastases;
- Patients whose primary lesion with active bleeding within 4 months
- Hypertension, which is uncontrolled by the drug, is defined as: systolic blood pressure ≥ 160 mmHg, or diastolic blood pressure ≥ 100 mmHg
- Patients with active or unable to control serious infections
- Patients who are pregnant or breastfeeding.
Sites / Locations
- Taizhou Hospital, Wenzhou Medical University
- Enze Hospital
- Sanmen People's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
S1/Anlotinib
Arm Description
Anlotinib 12mg qd, day 1 to day 14 followed by 7 days off treatment in a 21-day cycle until maximum 6 cycles； S1 60mg bid, day 1 to day 14 followed by 7 days off treatment in a 21-day cycle until it can not tolerate, or disease progression.
Outcomes
Primary Outcome Measures
Objective Response Rate (ORR)
measured by Response Evaluation Criteria in Solid Tumors version 1.1
progression-free survival (PFS)
PFS will be estimated using standard Kaplan Meier survival analysis methods.
Secondary Outcome Measures
Overall survival (OS)
OS will be estimated using standard Kaplan Meier survival analysis methods.
Incidence of adverse events
Incidence of adverse events per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03823118
Brief Title
S1 Plus Anlotinib in Treating Patients With Refractory or Relapsed Small-cell Lung Cancer
Official Title
S1 Plus Anlotinib in Treating Patients With Refractory or Relapsed Small-cell Lung Cancer：An One-arm, Phase Ⅱ, Multi-center Clinical Study (SALTER TRIAL)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
June 28, 2020 (Actual)
Study Completion Date
April 17, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taizhou Hospital
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
The purpose of this study is to assess the efficacy and safety of S1 combination with Anlotinib in patients with small cell lung cancer whose cancer has progression or recurrence after at least one standard chemotherapy.
Detailed Description
Although SCLC is very responsive to initial treatment, most patients relapse with relatively resistant disease.These patients have a median survival of only 4 to 5 months when treated with further systemic therapy. Improvements in therapy for relapsed SCLC are much needed.The purpose of this study is to assess the efficacy and safety of S1 combination with Anlotinib in patients with small cell lung cancer whose cancer has progression or recurrence after at least one standard chemotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer Recurrent
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
S1/Anlotinib
Arm Type
Experimental
Arm Description
Anlotinib 12mg qd, day 1 to day 14 followed by 7 days off treatment in a 21-day cycle until maximum 6 cycles； S1 60mg bid, day 1 to day 14 followed by 7 days off treatment in a 21-day cycle until it can not tolerate, or disease progression.
Intervention Type
Drug
Intervention Name(s)
S1/Anlotinib
Intervention Description
Anlotinib 12mg qd, day 1 to day 14 followed by 7 days off treatment in a 21-day cycle until maximum 6 cycles； S1 60mg bid, day 1 to day 14 followed by 7 days off treatment in a 21-day cycle until it can not tolerate, or disease progression.
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
measured by Response Evaluation Criteria in Solid Tumors version 1.1
Time Frame
each 21 days up to the toxicity or PD (up to 6 months)
Title
progression-free survival (PFS)
Description
PFS will be estimated using standard Kaplan Meier survival analysis methods.
Time Frame
Duration of time from the start of treatment to the first documented disease progression according to RECIST 1.1 or death due to any cause, whichever occurs first, assessed up to 12 months
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
OS will be estimated using standard Kaplan Meier survival analysis methods.
Time Frame
Duration of time from the start of treatment to date of death, assessed up to 2 years
Title
Incidence of adverse events
Description
Incidence of adverse events per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
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:
Histological or cytologically confirmed small cell lung cancer;
Systemic chemotherapy that has previously received at least one or more lines regimen, followed by disease progression or recurrence;
Age 18-75 years,ECOG PS:0-2,Life expectancy of more than 3 months
participants had at least one measurable target lesion by RECIST1.1
The main organ function meets the following criteria:absolute value of neutrophils ≥ 1.5 × 109 / L, platelets ≥80 × 109 / L, hemoglobin ≥ 80 g / L;total bilirubin ≤ 1.5 times the upper limit of normal value, aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times the upper limit of normal value (if liver metastasis, ≤ upper limit of normal value 5 times), serum creatinine ≤ 1.5 times the upper limit of normal;
Patients should participate in the study voluntarily and sign informed consent
Exclusion Criteria:
Patients who have been used anti-angiogenesis inhibitors,such as (such as sunitinib,bevacizumab,endostar et al.
Subjects with symptomatic brain metastases;
Patients whose primary lesion with active bleeding within 4 months
Hypertension, which is uncontrolled by the drug, is defined as: systolic blood pressure ≥ 160 mmHg, or diastolic blood pressure ≥ 100 mmHg
Patients with active or unable to control serious infections
Patients who are pregnant or breastfeeding.
Facility Information:
Facility Name
Taizhou Hospital, Wenzhou Medical University
City
Taizhou
State/Province
Zhejiang
ZIP/Postal Code
317000
Country
China
Facility Name
Enze Hospital
City
Taizhou
State/Province
Zhejiang
Country
China
Facility Name
Sanmen People's Hospital
City
Taizhou
State/Province
Zhejiang
Country
China
12. IPD Sharing Statement
Learn more about this trial
S1 Plus Anlotinib in Treating Patients With Refractory or Relapsed Small-cell Lung Cancer
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