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

NCT04835025 | Suspended DMC

• 1 other identifier: TJ-IRB20210338
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• overall survival

  3 years

Study Arms (1)

Control group (radiotherapy group)

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.

Drug: PD-1/PD-L1 inhibitor

Interventions

PD-1/PD-L1 inhibitor DRUG

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

Control group (radiotherapy group)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 non-small cell lung cancer; 4. Imaging confirmed brain metastasis (CT or MRI)

You may qualify if:

• Experimental group:
• years old ≤ age ≤ 75 years old, no gender limitation;
• NSCLC who have received radiotherapy for brain lesions + PD-1/PD-L1 immunotherapy;
• Histologically confirmed as NSCLC;
• Imaging confirmed brain metastasis (CT or MRI);
• The presence of imaging-evaluable lesions can be evaluated in accordance with RECIST 1.1
• Control group:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tongji Hospital: lead
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Wuhan University: collaborator
• Sun Yat-sen University: collaborator

Study Sites (1)

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

Wuhan, Hubei, 430030, China

Location

Related 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.

  PMID: 32008623 RESULT

• 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.

  PMID: 30955514 RESULT

• 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.

  PMID: 27535388 RESULT

• 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.

  PMID: 32158220 RESULT

• 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.

  PMID: 31813004 RESULT

• 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.

  PMID: 29700092 RESULT

• 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.

  PMID: 32723363 RESULT

• 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 brain metastases. Cancer. 2020 Dec 15;126(24):5274-5282. doi: 10.1002/cncr.33196. Epub 2020 Sep 14.

  PMID: 32926760 RESULT

• 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):4186-4197. doi: 10.1158/1078-0432.CCR-20-0798. Epub 2020 Apr 30.

  PMID: 32354698 RESULT

• 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: 10.1155/2019/3267409. eCollection 2019.

  PMID: 30853981 RESULT

• 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(2):160-164. doi: 10.1093/jjco/hyy171.

  PMID: 30452687 RESULT

• Vilarino 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;89:102067. doi: 10.1016/j.ctrv.2020.102067. Epub 2020 Jul 7.

  PMID: 32682248 RESULT

• 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 brain metastases. Radiat Oncol. 2020 Oct 27;15(1):245. doi: 10.1186/s13014-020-01644-x.

  PMID: 33109224 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: January 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: July 31, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

CN (1)