Camrelizumab Combined With Local Treatment in NSCLC Patients With BM

Sponsor

Zhejiang Cancer Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04291092

Collaborator

(none)

Enrollment

Location

Arm

41.9

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
NSCLC Stage IV Brain Metastases Immunotherapy	Drug: Immunotherapy Radiation: WBRT Drug: Chemotherapy	Phase 2

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 .

Study Design

Study Type:

Interventional

Anticipated Enrollment :

63 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 1, 2020

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: single-arm single-arm	Drug: Immunotherapy Immunotherapy for brain metastasis Other Names: Camrelizumab Radiation: WBRT local therapy for brain metastasis Other Names: SRS Drug: Chemotherapy Chemotherapy for brain metastasis

Arm

Intervention/Treatment

Experimental: single-arm

single-arm

Drug: Immunotherapy

Immunotherapy for brain metastasis

Other Names:

Camrelizumab

Radiation: WBRT

local therapy for brain metastasis

Other Names:

SRS

Drug: Chemotherapy

Chemotherapy for brain metastasis

Outcome Measures

Primary Outcome Measures

6 month progression-free survival rate [6 month]
6 month progression-free survival rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.