Back to resultsA Phase II Study of Sintilimab Combined With Anlotinib in Treatment of ED-SCLC
Primary Purpose
Small Cell Lung Cancer Extensive Stage
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Sintilimab
Anlotinib hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Small Cell Lung Cancer Extensive Stage
Eligibility Criteria
Inclusion Criteria:
- Aged ≥ 18, regardless of gender .
- Histologically or cytologically confirmed small cell lung cancer .
- The time after the end of first-line treatment was less than 6 months .
- Subjects must have measurable diseases as defined in RECIST v1.1 .
- Eastern Cooperative Oncology Group (ECOG) performance status scores are 0-2 .
- Adequate hematologic and end organ function .
- Capable of understanding the trial nature and voluntarily signing the written informed consent form .
Exclusion Criteria:
- Radiographic findings showed that the tumor involved large blood vessels or was poorly demarcated from them .
- Radiographic findings showed significant pulmonary cavitation or necrotizing tumor .
- Active brain metastasis or meningeal metastasis .
- With other malignant tumors in the past 5 years, except cancers that have been cured significantly or can be focally cured, e.g. basosquamous carcinoma of skin, or carcinoma cervix in situ .
- With Interstitial lung disease, including drug- induced Interstitial lung disease or radiation pneumonitis .
- With clinically significant cardiovascular disorder .
- Prior exposure to any immune checkpoint inhibitors, including but not limited to other anti-CTLA-4, anti-PD-1 or anti-PD-L1 antibodies .
- Prior exposure to anti-VEGFR therapy .
- Known hypersensitivity to study drug or any of its excipients .
- Treatment with any other investigational agent or participation in another clinical trial within 4 weeks prior to first administration .
- Other conditions that the investigator thinks unsuitable in this study .
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sintilimab + Anlotinib
Arm Description
sintilimab 200mg, IV, d1, Q3W and anlotinib 12mg, PO, QD，d1-14, Q3W; treatment until disease progression, unacceptable toxicity, or death
Outcomes
Primary Outcome Measures
ORR
Objective response rate according to RECIST v1.1
Secondary Outcome Measures
DCR
Disease control rate according to RECIST v1.1
DoR
Duration of response according to RECIST v1.1
PFS
Progression-free survival according to RECIST v1.1
OS
Overall survival
Adverse Event
Evaluation of adverse event rate according to CTCAE v4.03
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04967625
Brief Title
A Phase II Study of Sintilimab Combined With Anlotinib in Treatment of ED-SCLC
Official Title
Anti-PD-1 Antibody Sintilimab Combined With Anti-angeogensis Inhibitor Anlotinib in Treatment of Extensive-stage Disease Small Cell Lung Cancer After Failure of First Line Standard Therapy : a Single-arm Prospective Phase II Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 26, 2021 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Cancer 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 the researchers launched, single-center, prospective, open-label, single arm ,Phase II clinical study of Sintilimab combined with anlotinib in patients with extensive-stage disease small-cell lung cancer to evaluate the efficacy and safety.
23 patients are expected to be enrolled in this study.
Detailed Description
Subjects will receive sintilimab 200mg, IV, Q3W and anlotinib 12mg, PO, QD，d1-14, Q3W treatment until disease progression, unacceptable toxicity, or death.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer Extensive Stage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Anti-PD-1 antibody sintilimab combined With anti-angeogensis inhibitor anlotinib for extensive stage disease small cell lung cancer after failure of first line standard therapy
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sintilimab + Anlotinib
Arm Type
Experimental
Arm Description
sintilimab 200mg, IV, d1, Q3W and anlotinib 12mg, PO, QD，d1-14, Q3W; treatment until disease progression, unacceptable toxicity, or death
Intervention Type
Drug
Intervention Name(s)
Sintilimab
Intervention Description
A humanized anti-PD-1 monoclonal antibody
Intervention Type
Drug
Intervention Name(s)
Anlotinib hydrochloride
Intervention Description
A tyrosine kinase inhibitor selectively targeting VEGFR-2
Primary Outcome Measure Information:
Title
ORR
Description
Objective response rate according to RECIST v1.1
Time Frame
12 month
Secondary Outcome Measure Information:
Title
DCR
Description
Disease control rate according to RECIST v1.1
Time Frame
12 months
Title
DoR
Description
Duration of response according to RECIST v1.1
Time Frame
12 months
Title
PFS
Description
Progression-free survival according to RECIST v1.1
Time Frame
12 months
Title
OS
Description
Overall survival
Time Frame
on average of 2 years
Title
Adverse Event
Description
Evaluation of adverse event rate according to CTCAE v4.03
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged ≥ 18, regardless of gender .
Histologically or cytologically confirmed small cell lung cancer .
The time after the end of first-line treatment was less than 6 months .
Subjects must have measurable diseases as defined in RECIST v1.1 .
Eastern Cooperative Oncology Group (ECOG) performance status scores are 0-2 .
Adequate hematologic and end organ function .
Capable of understanding the trial nature and voluntarily signing the written informed consent form .
Exclusion Criteria:
Radiographic findings showed that the tumor involved large blood vessels or was poorly demarcated from them .
Radiographic findings showed significant pulmonary cavitation or necrotizing tumor .
Active brain metastasis or meningeal metastasis .
With other malignant tumors in the past 5 years, except cancers that have been cured significantly or can be focally cured, e.g. basosquamous carcinoma of skin, or carcinoma cervix in situ .
With Interstitial lung disease, including drug- induced Interstitial lung disease or radiation pneumonitis .
With clinically significant cardiovascular disorder .
Prior exposure to any immune checkpoint inhibitors, including but not limited to other anti-CTLA-4, anti-PD-1 or anti-PD-L1 antibodies .
Prior exposure to anti-VEGFR therapy .
Known hypersensitivity to study drug or any of its excipients .
Treatment with any other investigational agent or participation in another clinical trial within 4 weeks prior to first administration .
Other conditions that the investigator thinks unsuitable in this study .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lan Shao
Phone
+86 13456964958
Email
shaolan28@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guangyuan Lou
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
A Phase II Study of Sintilimab Combined With Anlotinib in Treatment of ED-SCLC
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