Clinical trial · Observational
Radiotherapy Combined With Immunotherapy for Brain Metastases of Non-small Cell Lung Cancer
A Retrospective, Multicenter Case-control Study of Radiotherapy Combined With Immunotherapy for Brain Metastases of Non-small Cell Lung Cancer
NCT04835025CI-TRIAL-00051107suspendedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): because of COVID-19
Summary
Brief summary (as posted)
This is a Retrospective, Multicenter, Controlled Study to Evaluate Immunotherapy and Radiotherpay for Brain Lesions as a Potential Treatment for Patients with Brain Metastasis in non-small cell lung cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD-1/PD-L1 inhibitor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Control group (radiotherapy group)
- description
- In non-small cell lung cancer, patients with brain metastases received radiotherapy for brain lesion (without limitation of dose and treatment method for radiotherapy) , but not receiving immunotherapy. Those patients would enter the control group. After patients experiencing disease progression(PD) in this group, follow-up treatment does not include immunotherapy until tumor progression again or death.
- interventionNames
- Drug: PD-1/PD-L1 inhibitor
Primary outcomes (1)
- measure
- progression-free surival
- timeFrame
- 3 years
- description
- Progression-free survival: From the first treatment to the date of first documentation of disease progression, or death due to any cause
Secondary outcomes (1)
- measure
- overall survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: Experimental group: 1. 18 years old ≤ age ≤ 75 years old, no gender limitation; 2. NSCLC who have received radiotherapy for brain lesions + PD-1/PD-L1 immunotherapy; 3. Histologically confirmed as NSCLC; 4. Imaging confirmed brain metastasis (CT or MRI); 5. The presence of imaging-evaluable lesions can be evaluated in accordance with RECIST 1.1 Control group: 1 18 years old ≤ age ≤ 75 years old, no gender limitation; 2 NSCLC who has received radiotherapy for brain lesions; 3 Histologically confirmed as non-small cell lung cancer; 4 Imaging confirmed brain metastasis (CT or MRI); 5 The presence of imaging-evaluable lesions can be evaluated in accordance with RECIST 1.1 \- Exclusion Criteria: 1 The age is less than 18 years old, regardless of gender; 2 Histologically confirmed as NSCLC 3 Imaging confirmed the absence of brain metastases 4 NSCLC with brain metastasis only received chemotherapy or targeted therapy, and did not receive radiotherapy or immunotherapy \-
References
Publications (13)
- RESULTBade BC, Dela Cruz CS. Lung Cancer 2020: Epidemiology, Etiology, and Prevention. Clin Chest Med. 2020 Mar;41(1):1-24. doi: 10.1016/j.ccm.2019.10.001. PMID 32008623
- RESULTNasim F, Sabath BF, Eapen GA. Lung Cancer. Med Clin North Am. 2019 May;103(3):463-473. doi: 10.1016/j.mcna.2018.12.006. PMID 30955514
- RESULTRodriguez-Canales J, Parra-Cuentas E, Wistuba II. Diagnosis and Molecular Classification of Lung Cancer. Cancer Treat Res. 2016;170:25-46. doi: 10.1007/978-3-319-40389-2_2. PMID 27535388
- RESULTWang S, Hu C, Xie F, Liu Y. Use of Programmed Death Receptor-1 and/or Programmed Death Ligand 1 Inhibitors for the Treatment of Brain Metastasis of Lung Cancer. Onco Targets Ther. 2020 Jan 23;13:667-683. doi: 10.2147/OTT.S235714. eCollection 2020. PMID 32158220
- RESULTLi W, Yu H. Separating or combining immune checkpoint inhibitors (ICIs) and radiotherapy in the treatment of NSCLC brain metastases. J Cancer Res Clin Oncol. 2020 Jan;146(1):137-152. doi: 10.1007/s00432-019-03094-9. Epub 2019 Dec 7. PMID 31813004
- RESULTJones GS, Baldwin DR. Recent advances in the management of lung cancer. Clin Med (Lond). 2018 Apr 1;18(Suppl 2):s41-s46. doi: 10.7861/clinmedicine.18-2-s41. PMID 29700092
- RESULTChen Y, Gao M, Huang Z, Yu J, Meng X. SBRT combined with PD-1/PD-L1 inhibitors in NSCLC treatment: a focus on the mechanisms, advances, and future challenges. J Hematol Oncol. 2020 Jul 28;13(1):105. doi: 10.1186/s13045-020-00940-z. PMID 32723363
- RESULTQian JM, Martin AM, Martin K, Hammoudeh L, Catalano PJ, Hodi FS, Cagney DN, Haas-Kogan DA, Schoenfeld JD, Aizer AA. Response rate and local recurrence after concurrent immune checkpoint therapy and radiotherapy for non-small cell lung cancer and melanoma brain metastases. Cancer. 2020 Dec 15;126(24):5274-5282. doi: 10.1002/cncr.33196. Epub 2020 Sep 14.