Back to resultsJS-201 Combined With Lenvatinib in the Treatment of Small-cell Lung Cancer
Primary Purpose
Small-cell Lung Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
JS201 combine with Lenvatinib
Sponsored by
About this trial
This is an interventional treatment trial for Small-cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- 1. The imaging diagnosis is the extensive stage of SCLC
- 2. The patient failed first-line EC+PD-L1 treatment
- 3 PS 0-1
Exclusion Criteria:
- 1. Diagnosed as non-small cell lung cancer
- 2. Women during pregnancy
- 3. Patients with symptomatic brain metastases
- 4. PS≥2
Sites / Locations
- Hunan Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm A
Arm Description
Treatment arm
Outcomes
Primary Outcome Measures
ORR
Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects
Secondary Outcome Measures
PFS
Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)
Full Information
NCT ID
NCT04951947
First Posted
June 30, 2021
Last Updated
February 28, 2022
Sponsor
Hunan Province Tumor Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04951947
Brief Title
JS-201 Combined With Lenvatinib in the Treatment of Small-cell Lung Cancer
Official Title
A Prospective, Single-arm Phase II Clinical Study to Evaluate the Efficacy and Safety of JS-201 Combined With Lenvatinib in the Treatment of Small-cell Lung Cancer With Previous Chemotherapy Combined With PD-L1 Failure
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hunan Province Tumor 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
This is a prospective, single-arm phase II clinical study to evaluate the efficacy and safety of JS-201 combined with lenvatinib in the treatment of small-cell lung cancer that has failed previous chemotherapy combined with PD-L1. The primary observational endpoint is ORR, and the secondary observational endpoint is PFS, OS. The intervention mode is JS201 300mg i.v Q2w, lenvatinib 8mg po. Qd.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small-cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
Treatment arm
Intervention Type
Drug
Intervention Name(s)
JS201 combine with Lenvatinib
Intervention Description
JS201 300mg i.v Q2wLenvatinib 8mg po. Qd
Primary Outcome Measure Information:
Title
ORR
Description
Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects
Time Frame
1 year
Secondary Outcome Measure Information:
Title
PFS
Description
Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)
Time Frame
1 year
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:
1. The imaging diagnosis is the extensive stage of SCLC
2. The patient failed first-line EC+PD-L1 treatment
3 PS 0-1
Exclusion Criteria:
1. Diagnosed as non-small cell lung cancer
2. Women during pregnancy
3. Patients with symptomatic brain metastases
4. PS≥2
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongchang Zhang, MD
Phone
+8613873123436
Ext
7+861383123436
Email
zhangyongchang@csu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Nong Yang, MD
Phone
+8613055193557
Ext
+8613873123436
Email
yangnong0217@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongchang Zhang, MD
Organizational Affiliation
Hunan Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nong Yang, MD
Phone
+86 731 89762323
Email
yangnong0217@163.com
First Name & Middle Initial & Last Name & Degree
Yongchang Zhang, MD
Phone
+86 731 89762321
Email
zhangyongchang@csu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
JS-201 Combined With Lenvatinib in the Treatment of Small-cell Lung Cancer
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