drugset / Trial / NCT07849712
An Exploratory Clinical Study Of Bempemab Combined With Anlotinib As First-Line Treatment For Elderly Patients With Locally Advanced Or Metastatic Non-Small-Cell Lung Cancer
NaSingle-groupOpen-labelTreatment
Summary
This exploratory clinical study evaluates the efficacy and safety of combining benmelstobart (a PD-L1 inhibitor) with anlotinib (a multi-target anti-angiogenic TKI) as a first-line, chemotherapy-free treatment for elderly patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).
Timeline
- Start
- 2026-10-01
- Primary completion
- 2028-12-31
- Completion
- 2028-12-31
Publications
- Background Maggiorani D, Le O, Lisi V, Landais S, Moquin-Beaudry G, Lavallee VP, Decaluwe H, Beausejour C. Senescence drives immunotherapy resistance by inducing an immunosuppressive tumor microenvironment. Nat Commun. 2024 Mar 18;15(1):2435. doi: 10.1038/s41467-024-46769-9.
- Background Wu M, Yan J, Qiao C, Yan C. Impact of Concurrent Media Exposure on Professional Identity: Cross-Sectional Study of 1087 Medical Students During Long COVID. J Med Internet Res. 2024 Oct 17;26:e50057. doi: 10.2196/50057.
- Background Tsukita Y, Tozuka T, Kushiro K, Hosokawa S, Sumi T, Uematsu M, Honjo O, Yamaguchi O, Asao T, Sugisaka J, Saito G, Shiihara J, Morita R, Katakura S, Yasuda T, Hisakane K, Miyauchi E, Morita S, Kobayashi K, Asahina H. Immunotherapy or Chemoimmunotherapy in Older Adults With Advanced Non-Small Cell Lung Cancer. JAMA Oncol. 2024 Apr 1;10(4):439-447. doi: 10.1001/jamaoncol.2023.6277.
- Background Voruganti T, Soulos PR, Mamtani R, Presley CJ, Gross CP. Association Between Age and Survival Trends in Advanced Non-Small Cell Lung Cancer After Adoption of Immunotherapy. JAMA Oncol. 2023 Mar 1;9(3):334-341. doi: 10.1001/jamaoncol.2022.6901.
- Background Nosaki K, Saka H, Hosomi Y, Baas P, de Castro G Jr, Reck M, Wu YL, Brahmer JR, Felip E, Sawada T, Noguchi K, Han SR, Piperdi B, Kush DA, Lopes G. Safety and efficacy of pembrolizumab monotherapy in elderly patients with PD-L1-positive advanced non-small-cell lung cancer: Pooled analysis from the KEYNOTE-010, KEYNOTE-024, and KEYNOTE-042 studies. Lung Cancer. 2019 Sep;135:188-195. doi: 10.1016/j.lungcan.2019.07.004. Epub 2019 Jul 8.
- Background Lee SM, Schulz C, Prabhash K, Kowalski D, Szczesna A, Han B, Rittmeyer A, Talbot T, Vicente D, Califano R, Cortinovis D, Le AT, Huang D, Liu G, Cappuzzo F, Reyes Contreras J, Reck M, Palmero R, Mak MP, Hu Y, Morris S, Hoglander E, Connors M, Biggane AM, Vollan HK, Peters S. First-line atezolizumab monotherapy versus single-agent chemotherapy in patients with non-small-cell lung cancer ineligible for treatment with a platinum-containing regimen (IPSOS): a phase 3, global, multicentre, open-label, randomised controlled study. Lancet. 2023 Aug 5;402(10400):451-463. doi: 10.1016/S0140-6736(23)00774-2. Epub 2023 Jul 6.
- Background Wu Y, Ju Q, Qian B, Zhang F, Shi H. The effectiveness of PD-1 inhibitors in non-small cell lung cancer (NSCLC) patients of different ages. Oncotarget. 2017 Dec 26;9(8):7942-7948. doi: 10.18632/oncotarget.23678. eCollection 2018 Jan 30.
- Background Hou C, Wang Z, Lu X. Impact of immunosenescence and inflammaging on the effects of immune checkpoint inhibitors. Cancer Pathog Ther. 2023 Aug 9;2(1):24-30. doi: 10.1016/j.cpt.2023.08.001. eCollection 2024 Jan.
- Background Xiong A, Wang J, Zhou C. Immunotherapy in the First-Line Treatment of NSCLC: Current Status and Future Directions in China. Front Oncol. 2021 Nov 25;11:757993. doi: 10.3389/fonc.2021.757993. eCollection 2021.
- Background Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Benmelstobart | Monoclonal antibody | 1200 mg | Intravenous |
| Subject | Catequentinib | Small molecule | 10 mg | Oral |