Back to resultsSHR-1210 Combined With Apatinib in Treatment of ED-SCLC After Failure of First Line Standard Therapy (PASSION)
Primary Purpose
Small-cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SHR-1210
Apatinib
Sponsored by
About this trial
This is an interventional treatment trial for Small-cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Signed inform consent form
- Age >= 18 years and <= 70 years
- Histologically or cytologically confirmed small cell lung cancer
- ED-SCLC according to Veterans Administration Lung Study Group
- Radiographically progression following a platinum-based standard prior chemotherapy regimen.
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Measurable disease as defined by RECIST v1.1
- Life expectancy >= 8 weeks
- Adequate hematologic and end organ function
Exclusion Criteria:
- Histologically or cytologically confirmed mixed non-small cell and small cell carcinoma
- Prior exposure to therapeutic anticancer vaccines; prior exposure to any T cell co-stimulatory therapy or immune checkpoint inhibitors, including but not limited to other anti-CTLA-4, anti-PD-1, anti-PD-L1 and anti-PD-L2 antibodies
- Prior exposure to anti-VEGF or anti-VEGFR therapy
- Active brain metastasis or meningeal metastasis.
- Clinically significant third space effusion (e.g., uncontrolled pericardial effusion, ascites or pleural effusion by extraction or other treatment)
- Known hypersensitivity to study drug or any of its excipients; known hypersensitivity to any antibody
- Treatment with any other investigational agent or participation in another clinical trial within 4 weeks prior to screening
- Other conditions that the investigator thinks unsuitable in this study
Sites / Locations
- Cancer Hospital Chinese Academy of Medical Science
- Zhejiang Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
A(SHR-1210+Apatinib)
B(SHR-1210+Apatinib)
C(SHR-1210+Apatinib)
Arm Description
• SHR-1210 200mg, IV, Q2W and Apatinib 375mg, PO, QD
• SHR-1210 200mg, IV, Q2W and Apatinib 375mg, PO, QD（5 Days on, 2 Days off）
• SHR-1210 200mg, IV, Q2W and Apatinib 375mg, PO, QD（7 Days on, 7 Days off）
Outcomes
Primary Outcome Measures
Adverse event of part 1
• Evaluation of adverse event rate according to CTCAE v4.03
ORR
• Objective response rate according to RECIST v1.1
Secondary Outcome Measures
Adverse event
• Evaluation of adverse event rate according to CTCAE v4.03
OS rate
• OS rate
PFS
• Progression-free survival according to RECIST v1.1
TTR
• Time to response according to RECIST v1.1
DoR
• Duration of response according to RECIST v1.1
DCR
• Disease control rate according to RECIST v1.1
OS
• Overall survival
Immunogenicity
• Positive rate of anti-drug antibody and neutralizing antibody
Full Information
NCT ID
NCT03417895
First Posted
January 8, 2018
Last Updated
February 1, 2023
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03417895
Brief Title
SHR-1210 Combined With Apatinib in Treatment of ED-SCLC After Failure of First Line Standard Therapy
Acronym
PASSION
Official Title
Anti-PD-1 Antibody SHR-1210 Combined With Anti-angiogenesis Inhibitor Apatinib in Treatment of Extensive-stage Disease Small Cell Lung Cancer After Failure of First Line Standard Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 20, 2018 (Actual)
Primary Completion Date
August 4, 2021 (Actual)
Study Completion Date
August 4, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine 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
No
5. Study Description
Brief Summary
This is a multi-center, open-label, phase II study of intravenous (IV) SHR-1210 at 200mg,q2w in combination with Apatinib at one dose (375mg). Comparison of 3 different dose schedules in subjects with extensive-stage disease small cell lung cancer. SHR-1210 is a humanized monoclonal antibody against Programmed death 1(PD-1). Apatinib is a new kind of selective Vascular Endothelial Growth Factor Receptor 2(VEGFR-2) tyrosine kinase inhibitor (TKI).
The study is composed of two parts. Part 1 of the study will determine the safety and tolerability of SHR-1210 in combination with Apatinib in first 6 subjects of each arm. The second phase of treatment was carried out by selecting one group of administration mode and the tolerated dose of Apatinib. Part 2 of the study will determine the safety and efficacy of SHR-1210 in combination with Apatinib in 39 subjects.
Detailed Description
Subjects will be 1:1:1 randomly assigned to receive
SHR-1210 200mg, IV, Q2W and Apatinib 375mg, PO, QD, or
SHR-1210 200mg, IV, Q2W and Apatinib 375mg, PO, QD（5 Days on, 2 Days off）, or
SHR-1210 200mg, IV, Q2W and Apatinib 375mg, PO, QD（7 Days on, 7 Days off） 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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A(SHR-1210+Apatinib)
Arm Type
Experimental
Arm Description
• SHR-1210 200mg, IV, Q2W and Apatinib 375mg, PO, QD
Arm Title
B(SHR-1210+Apatinib)
Arm Type
Experimental
Arm Description
• SHR-1210 200mg, IV, Q2W and Apatinib 375mg, PO, QD（5 Days on, 2 Days off）
Arm Title
C(SHR-1210+Apatinib)
Arm Type
Experimental
Arm Description
• SHR-1210 200mg, IV, Q2W and Apatinib 375mg, PO, QD（7 Days on, 7 Days off）
Intervention Type
Drug
Intervention Name(s)
SHR-1210
Intervention Description
A humanized anti-PD-1 monoclonal antibody
Intervention Type
Drug
Intervention Name(s)
Apatinib
Intervention Description
A tyrosine kinase inhibitor selectively targeting VEGFR-2
Primary Outcome Measure Information:
Title
Adverse event of part 1
Description
• Evaluation of adverse event rate according to CTCAE v4.03
Time Frame
on average of of 3 months(First 6 subjects in each arm)
Title
ORR
Description
• Objective response rate according to RECIST v1.1
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Adverse event
Description
• Evaluation of adverse event rate according to CTCAE v4.03
Time Frame
6 months
Title
OS rate
Description
• OS rate
Time Frame
6 months
Title
PFS
Description
• Progression-free survival according to RECIST v1.1
Time Frame
6 months
Title
TTR
Description
• Time to response according to RECIST v1.1
Time Frame
6 months
Title
DoR
Description
• Duration of response according to RECIST v1.1
Time Frame
6 months
Title
DCR
Description
• Disease control rate according to RECIST v1.1
Time Frame
6 months
Title
OS
Description
• Overall survival
Time Frame
on average of 2 years
Title
Immunogenicity
Description
• Positive rate of anti-drug antibody and neutralizing antibody
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed inform consent form
Age >= 18 years and <= 70 years
Histologically or cytologically confirmed small cell lung cancer
ED-SCLC according to Veterans Administration Lung Study Group
Radiographically progression following a platinum-based standard prior chemotherapy regimen.
Eastern Cooperative Oncology Group performance status of 0 or 1
Measurable disease as defined by RECIST v1.1
Life expectancy >= 8 weeks
Adequate hematologic and end organ function
Exclusion Criteria:
Histologically or cytologically confirmed mixed non-small cell and small cell carcinoma
Prior exposure to therapeutic anticancer vaccines; prior exposure to any T cell co-stimulatory therapy or immune checkpoint inhibitors, including but not limited to other anti-CTLA-4, anti-PD-1, anti-PD-L1 and anti-PD-L2 antibodies
Prior exposure to anti-VEGF or anti-VEGFR therapy
Active brain metastasis or meningeal metastasis.
Clinically significant third space effusion (e.g., uncontrolled pericardial effusion, ascites or pleural effusion by extraction or other treatment)
Known hypersensitivity to study drug or any of its excipients; known hypersensitivity to any antibody
Treatment with any other investigational agent or participation in another clinical trial within 4 weeks prior to screening
Other conditions that the investigator thinks unsuitable in this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Shi
Organizational Affiliation
Jiangsu Hengrui Pharmaceuticals Co.,Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Cancer Hospital Chinese Academy of Medical Science
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33166719
Citation
Fan Y, Zhao J, Wang Q, Huang D, Li X, Chen J, Fang Y, Duan J, Zhou C, Hu Y, Yang H, Hu Y, Zhou J, Lin X, Wang L, Wang Z, Xu Y, Zhang T, Shi W, Zou J, Wang J. Camrelizumab Plus Apatinib in Extensive-Stage SCLC (PASSION): A Multicenter, Two-Stage, Phase 2 Trial. J Thorac Oncol. 2021 Feb;16(2):299-309. doi: 10.1016/j.jtho.2020.10.002. Epub 2020 Nov 6.
Results Reference
derived
Learn more about this trial
SHR-1210 Combined With Apatinib in Treatment of ED-SCLC After Failure of First Line Standard Therapy
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