Camrelizumab Combined With Local Treatment in NSCLC Patients With BM

Study Purpose

To evaluate the efficacy and safety of Camrelizumab Combined with Chemotherapy and Local Treatment in non-small cell lung cancer with brain metastases.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age ≥18; 2. ECOG is 0-1; 3. Non-small cell lung cancer confirmed by histology; EGFR、ALK and ROS1 negative; 4. 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; 5. According to RECIST 1.1, there is at least one measurable extracranial and intracranial target lesion each; 6. Sign informed consent and agree to collect the clinical efficacy and information of the patient.

Exclusion Criteria:

1. Immunotherapeutic contraindications (including long-term use of hormones, history of radiation pneumonia, etc.) 2. Active autoimmune diseases (e.g. vitiligo, psoriasis, hypothyroidism requiring hormone replacement therapy, etc.) 3. Patients with active hepatitis B or C, HIV, active tuberculosis, etc.; 4. Active infections requiring antimicrobial therapy (e.g. antimicrobial, antiviral, antifungal); 5. History of known allogeneic organ transplantation and history of in vivo hematopoietic stem cell transplantation; 6. Patients with interstitial lung disease or previous history of interstitial pneumonia; 7. Having a history of substance abuse and unable to abstain from it or having mental disorders; 8. who have participated in other clinical trials of antitumor drugs within 4 weeks before entering the group; 9. Having used PD-1/PD-L1 and other immunotherapy drugs before entering the group; 10. 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; 11. (a) Pregnant or lactating women; those with fertility who are unwilling or unable to take effective contraception; 12. The researchers judged other situations that might affect the conduct of clinical studies and the determination of their findings.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04291092
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Zhejiang Cancer Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	NSCLC Stage IV, Brain Metastases, Immunotherapy

Additional Details

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 .

Arms & Interventions

Arms

Experimental: single-arm

single-arm

Interventions

Drug: - Immunotherapy

Immunotherapy for brain metastasis

Radiation: - WBRT

local therapy for brain metastasis

Drug: - Chemotherapy

Chemotherapy for brain metastasis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China

Status

Recruiting

Address

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022

Site Contact

Yun Fan, Dr

[email protected]

+86 057188122092

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