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

Sintilimab Combined With Bevacizumab for Brain Metastases From Non-small Cell Lung Cancer: Conditions:   Brain Metastases;   Non Small Cell Lung Cancer;   Sintilimab;   Bevacizumab Intervention:   Drug: sintilimab Sponsor:   Sun Yat-sen University Recruiting (Source: ClinicalTrials.gov)




Hide glossaryGlossary

Study record managers: refer to the Data Element Definitions if submitting registration or results information.



Search for terms



x

Accepts healthy volunteers

Active comparator arm

Adverse event

Age or age group

All-cause mortality

Allocation

Arm

Arm type

Baseline characteristics

Canceled submission

Certain agreements

Certification

Certification/extension first posted

Certification/extension first submitted

Certification/extension first submitted that met QC criteria

City and distance

Clinical study

Clinical trial

ClinicalTrials.gov identifier (NCT number)

Collaborator

Condition/disease

Contact

Country

Cross-over assignment

Data Monitoring Committee (DMC)

Early Phase 1 (formerly listed as Phase 0)

Eligibility criteria

Enrollment

Exclusion criteria

Expanded access

Expanded access status

Expanded access type

Experimental arm

Extension request

Factorial assignment

First posted

First submitted

First submitted that met QC criteria

Food and Drug Administration Amendments Act of 2007, Section 801 (FDAAA 801)

Funder type

Gender-based eligibility

Group/cohort

Human subjects protection review board

Inclusion criteria

Informed consent

Informed consent form (ICF)

Intervention model

Intervention/treatment

Interventional study (clinical trial)

Investigator

Last update posted

Last update submitted

Last update submitted that met QC criteria

Last verified

Listed location countries

Location terms

Masking

NCT number

No intervention arm

Observational study

Observational study model

Other adverse event

Other study IDs

Other terms

Outcome measure

Parallel assignment

Participant flow

Patient registry

Phase

Phase 1

Phase 2

Phase 3

Phase 4

Phase Not Applicable

Placebo

Placebo comparator arm

Primary completion date

Primary outcome measure

Primary purpose

Principal investigator (PI)

Protocol

Quality control (QC) review

Randomized allocation

Recruitment status

Registration

Removed location countries

Reporting group

Responsible party

Results database

Results delayed

Results first posted

Results first submitted

Results first submitted that met QC criteria

Results returned after quality control review

Results submitted to ClinicalTrials.gov

Secondary outcome measure

Serious adverse event

Sex

Sham comparator arm

Single group assignment

Sort studies by

Sponsor

State

Statistical analysis plan (SAP)

Status

Study completion date

Study design

Study documents

Study IDs

Study record

Study registry

Study results

Study start date

Study type

Submitted date

Title

Title acronym

U.S. Agency for Healthcare Research and Quality (AHRQ)

U.S. Food and Drug Administration (FDA)

Unknown

Skip to Main Content

ClinicalTrials.gov

Find StudiesFind Studies Menu

About StudiesAbout Studies Menu

Submit StudiesSubmit Studies Menu

ResourcesResources Menu

About SiteAbout Site Menu

HomeSearch ResultsStudy Record Detail Save this study

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

See Contacts and Locations

Sponsor:

Sun Yat-sen University

Information provided by (Responsible Party):

Li-kun Chen, Sun Yat-sen University



Study DetailsTabular ViewNo Results PostedDisclaimerHow to Read a Study Record

Study Description

Go to  sections

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



Study Design

Go to  sections

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

Genetics Home Reference related topics: Lung cancer

MedlinePlus related topics: Lung Cancer

Drug Information available for: Bevacizumab

U.S. FDA Resources



Arms and Interventions

Go to  sections

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







Outcome Measures

Go to  sections

Primary Outcome Measures  :

iORR [ Time Frame: 3.5 years ]

intracranial objective response rate





Secondary Outcome Measures  :

iPFS [ Time Frame: 3.5 yesrs ]

intracranial progression free survival



ORR [ Time Frame: 3.5 years ]

objective response rate



PFS [ Time Frame: 3.5 years ]

progression free survival





Eligibility Criteria

Go to  sections

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.





Ages Eligible for Study:  18 Years to 75 Years   (Adult, Older Adult)

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  No

Criteria

Inclusion Criteria:



Patients with NSCLC confirmed by histology or cytology;

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.

Appraisable disease, the diameter of at least one measurable lesion in the brain must be 5mm;

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).

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).

Ability to follow study and follow-up procedures;

Prior to the implementation of any trial-related procedures, a written informed consent shall be signed.

Exclusion Criteria:



Mixed non-small cell and small cell carcinoma;

Brain metastasis with hemorrhage;

Currently participating in interventional clinical research and treatment, or receiving other research drugs or using research instruments within 4 weeks before the first dose;

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);

Received solid organ or blood system transplantation;

Received >30GY pulmonary radiotherapy 6 months before the first dose;

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;

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;

History of non-infectious pneumonia requiring glucocorticoid therapy or current interstitial pulmonary disease was found within 1 year before the first dose;

History of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive)

Untreated active hepatitis;

History of hemoptysis within 3 months prior to selection, that is, at least 1/2 teaspoon of blood was coughed up;

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

Serious uncontrolled coagulation disorder or thrombi-embolic complications within 6 months prior to study start or history of serious bleeding complications.

Major surgical procedures within 4 weeks prior to study entry.

Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion.

Non-healing wound, active peptic ulcer or bone fracture.

History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrollment

Contacts and Locations

Go to  sections

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

Contact: Likun Chen, doctor 13798019964 chenlk@sysucc.org.cn



Locations

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

Study Director: Likun Chen, doctor Sun Yat-sen University

More Information

Go to  sections



Responsible Party: Li-kun Chen, medical doctor, Sun Yat-sen University

ClinicalTrials.gov Identifier: NCT04213170     History of Changes

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

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:

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Brain Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Neoplasms by Site

Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Neoplastic Processes

Pathologic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Nervous System Diseases

Bevacizumab

Antineoplastic Agents, Immunological

Antineoplastic Agents

Angiogenesis Inhibitors

Angiogenesis Modulating Agents

Growth Substances

Physiological Effects of Drugs

Growth Inhibitors





TO TOP

For Patients and Families For Researchers For Study Record Managers

HOME RSS FEEDS SITE MAP TERMS AND CONDITIONS DISCLAIMER CUSTOMER SUPPORT

Copyright Privacy Accessibility Viewers and Players Freedom of Information Act USA.gov

U.S. National Library of Medicine U.S. National Institutes of Health U.S. Department of Health and Human Services