Camrelizumab Combined With Local Treatment in NSCLC Patients With BM

NCT ID: NCT04291092

Last Updated: 2021-09-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2023-06-30

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 .

Conditions

NSCLC Stage IV; Brain Metastases; Immunotherapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single-arm

single-arm

Group Type: EXPERIMENTAL

Immunotherapy

Intervention Type: DRUG

Immunotherapy for brain metastasis

WBRT

Intervention Type: RADIATION

local therapy for brain metastasis

Chemotherapy

Intervention Type: DRUG

Chemotherapy for brain metastasis

Interventions

Immunotherapy

Immunotherapy for brain metastasis

Intervention Type: DRUG

WBRT

local therapy for brain metastasis

Intervention Type: RADIATION

Chemotherapy

Chemotherapy for brain metastasis

Intervention Type: DRUG

Other Intervention Names

Camrelizumab; SRS

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

GongLei

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Yun Fan, Dr

Role: primary

fanyun@zjcc.org.cn

+86 057188122092

References

Xu Y, Chen K, Xu Y, Li H, Huang Z, Lu H, Huang D, Yu S, Han N, Gong L, Qin J, Chen J, Xie F, Hong W, Lin X, Cheng F, Luo X, Fan Y. Brain radiotherapy combined with camrelizumab and platinum-doublet chemotherapy for previously untreated advanced non-small-cell lung cancer with brain metastases (C-Brain): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2025 Jan;26(1):74-84. doi: 10.1016/S1470-2045(24)00643-0.

Reference Type: DERIVED

PMID: 39756446 (View on PubMed)

Other Identifiers

XYJ20200101-1

Identifier Type: -

Identifier Source: org_study_id