Clinical trial NCT04291092: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: NSCLC Stage IV
Brain Metastases
Immunotherapy
Keywords: lung cancer
Brain Metastases
Camrelizumab
WBRT
SRS
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 .

Eligibility 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.

Primary outcomes:
measure: 6 month progression-free survival rate
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References: