Camrelizumab Combined With Local Treatment in NSCLC Patients With BM

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04291092

Enrollment

Registered

2020-03-02

Start date

2020-01-01

Completion date

2023-06-30

Last updated

2021-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NSCLC Stage IV, Brain Metastases, Immunotherapy

Keywords

lung cancer, Brain Metastases, Camrelizumab, WBRT, SRS

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 .

Interventions

DRUGImmunotherapy

Immunotherapy for brain metastasis

RADIATIONWBRT

local therapy for brain metastasis

DRUGChemotherapy

Chemotherapy for brain metastasis

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
6 month progression-free survival rate	6 month	6 month progression-free survival rate

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026