Camrelizumab Combined With Local Treatment in NSCLC Patients With BM

Study Overview
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Brief Summary
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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
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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 .

Official Title
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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

Conditions
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NSCLC Stage IV, Brain Metastases, Immunotherapy

Intervention / Treatment
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* Drug: Immunotherapy
* Radiation: WBRT
* Drug: Chemotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single-arm<br>single-arm | Drug: Immunotherapy<br>* Immunotherapy for brain metastasis<br>* Other names: Camrelizumab;Radiation: WBRT<br>* local therapy for brain metastasis<br>* Other names: SRS;Drug: Chemotherapy<br>* Chemotherapy for brain metastasis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 month progression-free survival rate | 6 month progression-free survival rate | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung cancer, Brain Metastases, Camrelizumab, WBRT, SRS