Radiotherapy Combined With Immunotherapy for Brain Metastases of Non-small Cell Lung Cancer

Non Small Cell Lung Cancer Clinical Trial

Official title:

A Retrospective, Multicenter Case-control Study of Radiotherapy Combined With Immunotherapy for Brain Metastases of Non-small Cell Lung Cancer

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04835025
• Other study ID #: TJ-IRB20210338
• Status: Suspended
• Start date: January 1, 2018
• Est. completion date: July 31, 2021

Study information

• Verified date: April 2021
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 200
• Est. completion date: July 31, 2021
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

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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

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Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• PD-1/PD-L1 inhibitor
In non-small cell lung cancer, patients with brain metastases received radiotherapy for brain lesions and immunotherapy (including sequential and concurrent model). Those patients would enter the trial group; After patients experiencing PD in this group, follow-up treatment until tumor progression again or death

Locations

Country	Name	City	State
China	Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, 430030, Hubei, P. R. China	Wuhan	Hubei

Sponsors (4)

Lead Sponsor	Collaborator
Tongji Hospital	Sun Yat-sen University, Wuhan Union Hospital, China, Wuhan University

Country where clinical trial is conducted

China, 

References & Publications (13)

Bade 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. Review. — View Citation

Chen 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. Review. — View Citation

Eguren-Santamaria I, Sanmamed MF, Goldberg SB, Kluger HM, Idoate MA, Lu BY, Corral J, Schalper KA, Herbst RS, Gil-Bazo I. PD-1/PD-L1 Blockers in NSCLC Brain Metastases: Challenging Paradigms and Clinical Practice. Clin Cancer Res. 2020 Aug 15;26(16):4186- — View Citation

Jones 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. Review. — View Citation

Kowalski ES, Remick JS, Sun K, Alexander GS, Khairnar R, Morse E, Cherng HR, Berg LJ, Poirier Y, Lamichhane N, Becker S, Chen S, Molitoris JK, Kwok Y, Regine WF, Mishra MV. Immune checkpoint inhibition in patients treated with stereotactic radiation for b — View Citation

Li 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. Review. — View Citation

Miyamoto S, Nomura R, Sato K, Awano N, Kuse N, Inomata M, Izumo T, Terada Y, Furuhata Y, Bae Y, Kunitoh H. Nivolumab and stereotactic radiation therapy for the treatment of patients with Stage IV non-small-cell lung cancer. Jpn J Clin Oncol. 2019 Feb 1;49 — View Citation

Nasim 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. Review. — View Citation

Protopapa M, Kouloulias V, Nikoloudi S, Papadimitriou C, Gogalis G, Zygogianni A. From Whole-Brain Radiotherapy to Immunotherapy: A Multidisciplinary Approach for Patients with Brain Metastases from NSCLC. J Oncol. 2019 Feb 3;2019:3267409. doi: 10.1155/20 — View Citation

Qian 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 — View Citation

Rodriguez-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. Review. — View Citation

Vilariño N, Bruna J, Bosch-Barrera J, Valiente M, Nadal E. Immunotherapy in NSCLC patients with brain metastases. Understanding brain tumor microenvironment and dissecting outcomes from immune checkpoint blockade in the clinic. Cancer Treat Rev. 2020 Sep; — View Citation

Wang 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. Review. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free surival	Progression-free survival: From the first treatment to the date of first documentation of disease progression, or death due to any cause	3 years
Secondary	overall survival	Overall survival: From the first administration to death from any cause	3 years