Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sintilimab Combined With Bevacizumab for Brain Metastases From Non-small Cell Lung Cancer

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04213170
Recruitment Status : Recruiting
First Posted : December 30, 2019
Last Update Posted : December 30, 2019
Sponsor:
Information provided by (Responsible Party):
Li-kun Chen, Sun Yat-sen University

Brief Summary:
This is a prospective phase II clinical study to assess the efficacy of Sintilimab combined with Bevacizumab for driving gene-negative, asymptomatic brain metastases from non-small cell lung cancer by intracranial ORR(iORR),also iPFS,ORR and PFS.The safety and tolerability is evaluated as well.

Condition or disease Intervention/treatment Phase
Brain Metastases Non Small Cell Lung Cancer Sintilimab Bevacizumab Drug: sintilimab Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Phase II Clinical Study of Sintilimab Combined With Bevacizumab for Driving Gene-negative, Asymptomatic Brain Metastases From Non-small Cell Lung Cancer
Actual Study Start Date : April 29, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: Sintilimab and Bevacizumab
Sintilimab 200mg d1 and Bevacizumab 15mg/kg d1 every 21 days
Drug: sintilimab
Sintilimab 200mg d1 and Bevacizumab 15mg/kg d1 q21d
Other Name: bevacizumab




Primary Outcome Measures :
  1. iORR [ Time Frame: 3.5 years ]
    intracranial objective response rate


Secondary Outcome Measures :
  1. iPFS [ Time Frame: 3.5 yesrs ]
    intracranial progression free survival

  2. ORR [ Time Frame: 3.5 years ]
    objective response rate

  3. PFS [ Time Frame: 3.5 years ]
    progression free survival



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with NSCLC confirmed by histology or cytology;
  2. Patients with asymptomatic brain metastasis or brain metastasis whose symptoms of intracranial hypertension have been alleviated after dehydration treatment should keep the clinical stable state for at least 2 weeks.For patients requiring hormone dehydration therapy, hormone therapy should be discontinued 3 days before the first dose of the study drug.
  3. Appraisable disease, the diameter of at least one measurable lesion in the brain must be 5mm;
  4. The detection results of tumor tissue biomarkers should meet the following conditions simultaneously: EGFR has no sensitive mutation;ALK rearrangement negative;for never treated patients, they also needed to meet PD-L1 >50% or TMB>12Mut/Mb (second-generation sequencing).
  5. Adult patients (≥ 18 years and ≤75 years). ECOG Performance Status 0 or 1 Life expectancy of at least 12 weeks.,Haemoglobin ³ 10.0 g/dl, Absolute neutrophil count (ANC) ³1.5 x 109/L, platelets ³ 100 x 109/L. Total bilirubin £ 1.5 x upper limit of normal (ULN). ALT and AST < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases. Creatinine clearance ³ 60ml/min (calculated according to Cockcroft-gault formula).
  6. Ability to follow study and follow-up procedures;
  7. Prior to the implementation of any trial-related procedures, a written informed consent shall be signed.

Exclusion Criteria:

  1. Mixed non-small cell and small cell carcinoma;
  2. Brain metastasis with hemorrhage;
  3. Currently participating in interventional clinical research and treatment, or receiving other research drugs or using research instruments within 4 weeks before the first dose;
  4. Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs targeting another stimulation or synergistic inhibition of T cell receptors (e.g., CTLA-4, CD137);
  5. Received solid organ or blood system transplantation;
  6. Received >30GY pulmonary radiotherapy 6 months before the first dose;
  7. Active autoimmune diseases requiring systemic treatment (such as the use of disease-relieving drugs, corticosteroids or immunosuppressants) occurred within 2 years before the first dose.Alternative therapies (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic;
  8. Received systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of the study or diagnosed as immunodeficiency;a physiological dose of glucocorticoid (10 mg/ day of prednisone or equivalent) is permitted;
  9. History of non-infectious pneumonia requiring glucocorticoid therapy or current interstitial pulmonary disease was found within 1 year before the first dose;
  10. History of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive)
  11. Untreated active hepatitis;
  12. History of hemoptysis within 3 months prior to selection, that is, at least 1/2 teaspoon of blood was coughed up;
  13. Imaging showed signs of tumor invasion into the great vessels.The investigator or radiologist must rule out patients whose tumors have completely approached, wrapped, or invaded the intravascular space of the great vessels
  14. Serious uncontrolled coagulation disorder or thrombi-embolic complications within 6 months prior to study start or history of serious bleeding complications.
  15. Major surgical procedures within 4 weeks prior to study entry.
  16. Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion.
  17. Non-healing wound, active peptic ulcer or bone fracture.
  18. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrollment

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): NCT04213170


Contacts
Layout table for location contacts
Contact: Likun Chen, doctor 13798019964 chenlk@sysucc.org.cn

Locations
Layout table for location information
China, Guangdong
Sun Yat-sen University of Cancer Center Recruiting
Guangzhou, Guangdong, China
Contact: Likun Chen, doctor    13798019964    chenlk@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Layout table for investigator information
Study Director: Likun Chen, doctor Sun Yat-sen University

Layout table for additonal information
Responsible Party: Li-kun Chen, medical doctor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04213170    
Other Study ID Numbers: B2019-050-01
First Posted: December 30, 2019    Key Record Dates
Last Update Posted: December 30, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Neoplasm Metastasis
Brain Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Bronchial Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Central Nervous System Diseases
Carcinoma, Non-Small-Cell Lung
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Neoplastic Processes
Pathologic Processes
Brain Diseases
Nervous System Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors