SHR-1210 Combined With Apatinib in Treatment of ED-SCLC After Failure of First Line Standard Therapy
PASSION
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
1 other identifier
interventional
59
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2018
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2018
CompletedFirst Posted
Study publicly available on registry
January 31, 2018
CompletedStudy Start
First participant enrolled
April 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 4, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 4, 2021
CompletedResults Posted
Study results publicly available
August 7, 2024
CompletedAugust 7, 2024
April 1, 2023
3.3 years
January 8, 2018
April 12, 2023
February 25, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Adverse Event
Evaluation of adverse event rate according to CTCAE v4.03
24 months
ORR
Objective response rate according to RECIST v1.1 (Response was assessed with CT or MRI using RECIST v1.1, Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to\<10 mm; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Over all response：CR+PR)
6 months
Secondary Outcomes (6)
OS Rate
6 months
PFS
Imaging assessment was performed on C1D28 and every 8 weeks after C1D28 until radiographic progressive disease (PD) was documented.
TTR
Imaging assessment was performed on C1D28 and every 8 weeks after C1D28 until radiographic progressive disease (PD) was documented.
DoR
Imaging assessment was performed on C1D28 and every 8 weeks after C1D28 until radiographic progressive disease (PD) was documented.
DCR
Imaging assessment was performed on C1D28 and every 8 weeks after C1D28 until radiographic progressive disease (PD) was documented.
- +1 more secondary outcomes
Study Arms (3)
A (SHR-1210+Apatinib)
EXPERIMENTALSHR-1210 200mg, IV, Q2W and Apatinib 375mg, PO, QD
B (SHR-1210+Apatinib)
EXPERIMENTALSHR-1210 200mg, IV, Q2W and Apatinib 375mg, PO, QD (5 Days on, 2 Days off)
C (SHR-1210+Apatinib)
EXPERIMENTALSHR-1210 200mg, IV, Q2W and Apatinib 375mg, PO, QD (7 Days on, 7 Days off)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100021, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
Related Publications (1)
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.
PMID: 33166719DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Yuanchao Wang; SPM
- Organization
- Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Study Officials
- STUDY DIRECTOR
Wei Shi
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2018
First Posted
January 31, 2018
Study Start
April 20, 2018
Primary Completion
August 4, 2021
Study Completion
August 4, 2021
Last Updated
August 7, 2024
Results First Posted
August 7, 2024
Record last verified: 2023-04