drugset / Trial / NCT06714708
Low Dose Radiotherapy Combined With Sintilimab and Chemotherapy as Neoadjuvant Therapy for Stage II-III NSCLC
RandomizedParallel-groupOpen-labelTreatment
Summary
To evaluate efficacy and safety of low dose radiotherapy combined with sintilimab and platinum based chemotherapy as neoadjuvant therapy for stage II-III Non-Small Cell Lung Cancer
Timeline
- Start
- 2024-11-20
- Primary completion
- 2026-12-01
- Completion
- 2027-06-01
Publications
- Background Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N; CheckMate 816 Investigators. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. N Engl J Med. 2022 May 26;386(21):1973-1985. doi: 10.1056/NEJMoa2202170. Epub 2022 Apr 11.
- Background Li J, Lu S, Tian Y, Jiang L, Li L, Xie SH, Li Q. Neoadjuvant low-dose radiotherapy plus durvalumab and chemotherapy for potentially resectable stage III NSCLC: A phase Ib dose-escalation study. Radiother Oncol. 2024 Jul;196:110316. doi: 10.1016/j.radonc.2024.110316. Epub 2024 Apr 26.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Background | Carboplatin | Small molecule | 6 unknown | Intravenous |
| Background | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 130 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 260 mg/m2 | Intravenous |
| Background | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |
| Background | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |