drugset / Trial / NCT03732664
ICIs Neoadjuvant Therapy in Resectable Non-Small-Cell Lung Cancer
NaSingle-groupOpen-labelTreatment
Summary
The proposed study will evaluate the safety and feasibility of preoperative administration nivolumab in patients with high-risk resectable NSCLC, and will facilitate a comprehensive exploratory characterization of the tumor immune milieu and circulating immune cells and soluble factors in these patients. Data obtained in this study will provide valuable information for planning further prospective clinical trials of anti-PD-1 or anti-PD-L1 in NSCLC, both in the peri-operative and advanced disease setting.
Timeline
- Start
- 2018-10-01
- Primary completion
- 2023-03-23
- Completion
- 2023-03-23
Publications
- Background Forde PM, Chaft JE, Smith KN, Anagnostou V, Cottrell TR, Hellmann MD, Zahurak M, Yang SC, Jones DR, Broderick S, Battafarano RJ, Velez MJ, Rekhtman N, Olah Z, Naidoo J, Marrone KA, Verde F, Guo H, Zhang J, Caushi JX, Chan HY, Sidhom JW, Scharpf RB, White J, Gabrielson E, Wang H, Rosner GL, Rusch V, Wolchok JD, Merghoub T, Taube JM, Velculescu VE, Topalian SL, Brahmer JR, Pardoll DM. Neoadjuvant PD-1 Blockade in Resectable Lung Cancer. N Engl J Med. 2018 May 24;378(21):1976-1986. doi: 10.1056/NEJMoa1716078. Epub 2018 Apr 16.
- Chen Y, Shao Z, Hao Z, Xin Z, Chen X, Huang L, Chen D, Lin M, Liu Q, Xu X, Li J, Wu D, Yan J, Chai Y, Wu P. Epithelium/imcDC2 axis facilitates the resistance of neoadjuvant anti-PD-1 in human NSCLC. J Immunother Cancer. 2024 Aug 12;12(8):e007854. doi: 10.1136/jitc-2023-007854.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Durvalumab | Monoclonal antibody | — | — |
| Subject | Nivolumab | Monoclonal antibody | — | — |
| Subject | Pembrolizumab | Monoclonal antibody | — | — |
| Subject | Sintilimab | Monoclonal antibody | — | — |
| Subject | Tislelizumab | Monoclonal antibody | — | — |
| Subject | Toripalimab | Monoclonal antibody | — | — |
Indications
No indication recorded.