Clinical trial · Interventional
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
NCT04291092CI-TRIAL-00053829unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the efficacy and safety of Camrelizumab Combined with Chemotherapy and Local Treatment in non-small cell lung cancer with brain metastases.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases | — | UNRESOLVED | — |
| Immunotherapy | — | UNRESOLVED | — |
| NSCLC Stage IV | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Immunotherapy | Drug | Immunotherapy | ALIAS |
| WBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- single-arm
- description
- single-arm
- interventionNames
- Drug: Immunotherapy
- Radiation: WBRT
- Drug: Chemotherapy
Primary outcomes (1)
- measure
- 6 month progression-free survival rate
- timeFrame
- 6 month
- description
- 6 month progression-free survival rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDXu 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. PMID 39756446