Camrelizumab Combined With Local Treatment in NSCLC Patients With BM

Phase 2

• Conditions: NSCLC Stage IV; Brain Metastases; Immunotherapy
• Interventions: Drug: Immunotherapy; Radiation: WBRT; Drug: Chemotherapy

• Registration Number: NCT04291092
• Lead Sponsor: Zhejiang Cancer Hospital

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 .

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-01-08
• Study First Submitted QC: 2020-02-27
• Study First Posted: 2020-03-02
• Status Verified: 2021-08
• Last Update Submitted: 2021-09-03
• Last Update Posted: 2021-09-10
• Primary Completion: 2022-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 63

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single-arm	Immunotherapy	single-arm
single-arm	WBRT	single-arm
single-arm	Chemotherapy	single-arm

Primary Outcome Measures

Name	Time	Method
6 month progression-free survival rate	6 month	6 month progression-free survival rate

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China