Camrelizumab Combined With Local Treatment in NSCLC Patients With BM

Brain Metastases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04291092
• Other study ID #: XYJ20200101-1
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2021
• Source: Zhejiang Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 63
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Immunotherapy
• Neoplasm Metastasis
• NSCLC Stage IV

Intervention

Drug:
• Immunotherapy
Immunotherapy for brain metastasis

Radiation:
• WBRT
local therapy for brain metastasis

Drug:
• Chemotherapy
Chemotherapy for brain metastasis

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 month progression-free survival rate	6 month progression-free survival rate	6 month