Stereotactic Radiotherapy Plus Anlotinib with or without Toripalimab in Newly Treated Non-Small Cell Lung Cancer Patients with Brain Oligometastatic-Metastases: A Prospective Study Multi-Cohort Phase Ib Clinical Study Trial

Jia Ma, Jianping Bi, Guoliang Pi, Ying Li, Hanping He, Yanping Li, Shi H, Zeng F, Vivek V, Desheng Hu and Han G

Department of Radiation Oncology, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology, China
Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, USA

^*Correspondance to: Guang Han 

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Abstract:

Lung cancer harbors the highest mortality in the world and China, which is a devastating disease to people and poses a huge burden to both families and society. At present, the main treatment methods of driver mutation-negative advanced Non-Small Cell Lung Cancer (NSCLC) are chemotherapy, immunotherapy, anti-angiogenic therapy, and radiotherapy etc. However, the treatment effect still cannot meet the needs, and the side effects of therapy are sometimes severe and several patients just can’t struggle it. In this article, we propose a clinical trial in the NSCLC patients with brain metastasis. This is a single-center, multi-cohort phase Ib clinical trial (NCT05021328) that evaluates the safety and efficacy of combining immune checkpoint inhibition, angiogenesis pathway inhibitors, and Stereotactic Radiotherapy (SRT) in driver mutation-negative NSCLC patients with 1-5 brain metastasis (oligometastasis). The patients will be assigned into two cohorts: SRT of brain metastasis (35Gy/5fx) and concurrent anlotinib, or SRT (35Gy/5fx) plus concurrent anlotinib and toripalimab. After brain SRT, both groups will receive maintenance toripalimab combined with anlotinib for up to 1 year. The primary endpoints are safety and intracranial Overall Response rate (iORR). The secondary endpoints include intracranial progression-free survival, local control, overall survival, and the maximum response rate of lesions in non-irradiated areas, the distant effect of radiotherapy enhanced by toripalimab, quality of life, and cognitive function. It is hoped that this chemotherapyfree regimen will merit further investigation for brain metastases from NSCLC.

Keywords:

Non-small lung cancer; Brain metastases; Stereotactic radiotherapy; Anlotinib; Toripalimab

Cite the Article:

Jia Ma, Jianping Bi, Guoliang Pi, Ying Li, Hanping He, Yanping Li, et al. Stereotactic Radiotherapy Plus Anlotinib with or without Toripalimab in Newly Treated Non-Small Cell Lung Cancer Patients with Brain Oligometastatic- Metastases: A Prospective Study Multi- Cohort Phase Ib Clinical Study Trial. Clin Oncol. 2024;9:2081..