Camrelizumab Combined With Local Treatment in NSCLC Patients With BM
Primary Purpose
NSCLC Stage IV, Brain Metastases, Immunotherapy
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Immunotherapy
WBRT
Chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for NSCLC Stage IV focused on measuring lung cancer, Brain Metastases, Camrelizumab, WBRT, SRS
Eligibility Criteria
Inclusion Criteria:
- Age ≥18;
- ECOG is 0-1;
- Non-small cell lung cancer confirmed by histology; EGFR、ALK and ROS1 negative;
- The presence of brain metastases as determined by imaging, with unlimited numbers, the intracranial lesions had a maximum diameter of ≥ 0.5cm,allowing the presence of clinical symptoms of brain metastases;
- According to RECIST 1.1, there is at least one measurable extracranial and intracranial target lesion each;
- Sign informed consent and agree to collect the clinical efficacy and information of the patient.
Exclusion Criteria:
- Immunotherapeutic contraindications (including long-term use of hormones, history of radiation pneumonia, etc.)
- Active autoimmune diseases (e.g. vitiligo, psoriasis, hypothyroidism requiring hormone replacement therapy, etc.)
- Patients with active hepatitis B or C, HIV, active tuberculosis, etc.;
- Active infections requiring antimicrobial therapy (e.g. antimicrobial, antiviral, antifungal);
- History of known allogeneic organ transplantation and history of in vivo hematopoietic stem cell transplantation;
- Patients with interstitial lung disease or previous history of interstitial pneumonia;
- Having a history of substance abuse and unable to abstain from it or having mental disorders;
- who have participated in other clinical trials of antitumor drugs within 4 weeks before entering the group;
- Having used PD-1/PD-L1 and other immunotherapy drugs before entering the group;
- previous or concurrent with other untreated malignancies, except for cured basal cell carcinoma of the skin, carcinoma of the cervix in situ and superficial bladder cancer;
- (a) Pregnant or lactating women; those with fertility who are unwilling or unable to take effective contraception;
- The researchers judged other situations that might affect the conduct of clinical studies and the determination of their findings.
Sites / Locations
- Zhejiang Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
single-arm
Arm Description
single-arm
Outcomes
Primary Outcome Measures
6 month progression-free survival rate
6 month progression-free survival rate
Secondary Outcome Measures
Full Information
NCT ID
NCT04291092
First Posted
January 8, 2020
Last Updated
September 3, 2021
Sponsor
Zhejiang Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04291092
Brief Title
Camrelizumab Combined With Local Treatment in NSCLC Patients With BM
Official Title
Camrelizumab Combined With Chemotherapy and Local Treatment in Non-small Cell Lung Cancer Patients With Brain Metastasis, a Single-arm, Multi-center, Open-labeled Phase II Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang Cancer Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To evaluate the efficacy and safety of Camrelizumab Combined with Chemotherapy and Local Treatment in non-small cell lung cancer with brain metastases.
Detailed Description
To evaluate the efficacy and safety of Camrelizumab Combined with Chemotherapy and Local Treatment of brain metastases (WBRT, r-knife, SRS, etc.) in non-small cell lung cancer patients with brain metastases .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NSCLC Stage IV, Brain Metastases, Immunotherapy
Keywords
lung cancer, Brain Metastases, Camrelizumab, WBRT, SRS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
single-arm
Arm Type
Experimental
Arm Description
single-arm
Intervention Type
Drug
Intervention Name(s)
Immunotherapy
Other Intervention Name(s)
Camrelizumab
Intervention Description
Immunotherapy for brain metastasis
Intervention Type
Radiation
Intervention Name(s)
WBRT
Other Intervention Name(s)
SRS
Intervention Description
local therapy for brain metastasis
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Intervention Description
Chemotherapy for brain metastasis
Primary Outcome Measure Information:
Title
6 month progression-free survival rate
Description
6 month progression-free survival rate
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18;
ECOG is 0-1;
Non-small cell lung cancer confirmed by histology; EGFR、ALK and ROS1 negative;
The presence of brain metastases as determined by imaging, with unlimited numbers, the intracranial lesions had a maximum diameter of ≥ 0.5cm,allowing the presence of clinical symptoms of brain metastases;
According to RECIST 1.1, there is at least one measurable extracranial and intracranial target lesion each;
Sign informed consent and agree to collect the clinical efficacy and information of the patient.
Exclusion Criteria:
Immunotherapeutic contraindications (including long-term use of hormones, history of radiation pneumonia, etc.)
Active autoimmune diseases (e.g. vitiligo, psoriasis, hypothyroidism requiring hormone replacement therapy, etc.)
Patients with active hepatitis B or C, HIV, active tuberculosis, etc.;
Active infections requiring antimicrobial therapy (e.g. antimicrobial, antiviral, antifungal);
History of known allogeneic organ transplantation and history of in vivo hematopoietic stem cell transplantation;
Patients with interstitial lung disease or previous history of interstitial pneumonia;
Having a history of substance abuse and unable to abstain from it or having mental disorders;
who have participated in other clinical trials of antitumor drugs within 4 weeks before entering the group;
Having used PD-1/PD-L1 and other immunotherapy drugs before entering the group;
previous or concurrent with other untreated malignancies, except for cured basal cell carcinoma of the skin, carcinoma of the cervix in situ and superficial bladder cancer;
(a) Pregnant or lactating women; those with fertility who are unwilling or unable to take effective contraception;
The researchers judged other situations that might affect the conduct of clinical studies and the determination of their findings.
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yun Fan, Dr
Phone
+86 057188122092
Email
fanyun@zjcc.org.cn
12. IPD Sharing Statement
Learn more about this trial
Camrelizumab Combined With Local Treatment in NSCLC Patients With BM
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