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SHR-1210 Combined With Apatinib in Treatment of ED-SCLC After Failure of First Line Standard Therapy (PASSION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03417895
Recruitment Status : Completed
First Posted : January 31, 2018
Last Update Posted : February 3, 2023
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Small-cell Lung Cancer Drug: SHR-1210 Drug: Apatinib Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 20, 2018
Actual Primary Completion Date : August 4, 2021
Actual Study Completion Date : August 4, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: A(SHR-1210+Apatinib)
• SHR-1210 200mg, IV, Q2W and Apatinib 375mg, PO, QD
 Drug: SHR-1210
A humanized anti-PD-1 monoclonal antibody

Drug: Apatinib
A tyrosine kinase inhibitor selectively targeting VEGFR-2
Experimental: B(SHR-1210+Apatinib)
• SHR-1210 200mg, IV, Q2W and Apatinib 375mg, PO, QD（5 Days on, 2 Days off）
 Drug: SHR-1210
A humanized anti-PD-1 monoclonal antibody

Drug: Apatinib
A tyrosine kinase inhibitor selectively targeting VEGFR-2
Experimental: C(SHR-1210+Apatinib)
• SHR-1210 200mg, IV, Q2W and Apatinib 375mg, PO, QD（7 Days on, 7 Days off）
 Drug: SHR-1210
A humanized anti-PD-1 monoclonal antibody

Drug: Apatinib
A tyrosine kinase inhibitor selectively targeting VEGFR-2


Outcome Measures
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Primary Outcome Measures :
  1. Adverse event of part 1 [ Time Frame: on average of of 3 months(First 6 subjects in each arm) ]
    • Evaluation of adverse event rate according to CTCAE v4.03

  2. ORR [ Time Frame: 6 months ]
    • Objective response rate according to RECIST v1.1


Secondary Outcome Measures :
  1. Adverse event [ Time Frame: 6 months ]
    • Evaluation of adverse event rate according to CTCAE v4.03

  2. OS rate [ Time Frame: 6 months ]
    • OS rate

  3. PFS [ Time Frame: 6 months ]
    • Progression-free survival according to RECIST v1.1

  4. TTR [ Time Frame: 6 months ]
    • Time to response according to RECIST v1.1

  5. DoR [ Time Frame: 6 months ]
    • Duration of response according to RECIST v1.1

  6. DCR [ Time Frame: 6 months ]
    • Disease control rate according to RECIST v1.1

  7. OS [ Time Frame: on average of 2 years ]
    • Overall survival

  8. Immunogenicity [ Time Frame: 6 months ]
    • Positive rate of anti-drug antibody and neutralizing antibody


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed inform consent form
  2. Age >= 18 years and <= 70 years
  3. Histologically or cytologically confirmed small cell lung cancer
  4. ED-SCLC according to Veterans Administration Lung Study Group
  5. Radiographically progression following a platinum-based standard prior chemotherapy regimen.
  6. Eastern Cooperative Oncology Group performance status of 0 or 1
  7. Measurable disease as defined by RECIST v1.1
  8. Life expectancy >= 8 weeks
  9. Adequate hematologic and end organ function

Exclusion Criteria:

  1. Histologically or cytologically confirmed mixed non-small cell and small cell carcinoma
  2. 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
  3. Prior exposure to anti-VEGF or anti-VEGFR therapy
  4. Active brain metastasis or meningeal metastasis.
  5. Clinically significant third space effusion (e.g., uncontrolled pericardial effusion, ascites or pleural effusion by extraction or other treatment)
  6. Known hypersensitivity to study drug or any of its excipients; known hypersensitivity to any antibody
  7. Treatment with any other investigational agent or participation in another clinical trial within 4 weeks prior to screening
  8. Other conditions that the investigator thinks unsuitable in this study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417895


Locations
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China, Beijing
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing, China, 100021
China, Zhejiang
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Investigators
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Study Director: Wei Shi Jiangsu Hengrui Pharmaceuticals Co.,Ltd
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03417895    
Other Study ID Numbers: SHR-1210-II-206
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: February 3, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Carcinoma, Bronchogenic
Bronchial Neoplasms
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action