Immunotherapy Combined with Hypofractionated Concurrent Chemoradiotherapy Followed by Immu
Patients with locally advanced NSCLC (Non-Small Cell Lung Cancer) who have a PD-L1 TPS ≥ 20% will be included in this study. It aims to explore the efficacy and safety of immunotherapy combined with hypofractionated concurrent chemoradiotherapy, followed by consolidation immunotherapy. Participants will undergo large f
| Condition(s) | Non-Small Cell Lung Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | Patients with locally advanced NSCLC (Non-Small Cell Lung Cancer) who have a PD-L1 TPS ≥ 20% will be included in this study. It aims to explore the efficacy and safety of immunotherapy combined with hypofractionated concurrent chemoradiotherapy, followed by consolidation immunotherapy. Participants will undergo large fractionated radiotherapy with a total dose of 48Gy/16 fractions, 3Gy per fraction, 5 days a week. Participants will receive two cycles of concurrent platinum-based doublet chemotherapy and concurrent immunotherapy. Patients without progression will receive consolidation immunotherapy. The maximum duration of immunotherapy is 24 months. |
| Who can participate | Inclusion Criteria: 1. Sign a written informed consent before implementing any trial-related procedures. 2. Age ≥ 18 years and ≤ 70 years, male or female. 3. Histologically or cytologically confirmed inoperable locally advanced (IIB-IIIC) NSCLC (International Association for the Study of Lung Cancer and American Joint Committee on Cancer 8th edition TNM lung cancer staging); Notes: 1. If EBUS/EUS or mediastinoscopy can safely obtain samples from the hilar or mediastinal lymph nodes, it is encouraged to obtain tissue for confirmation of involvement. When the lymph node boundary is clear and at least one lymph node has a short axis ≥ 2.0 cm, lymph node involvement can be determined by imaging (CT/MRI scan). For lymph nodes with a short axis \< 2.0 cm, if pathologically confirmed, the patient |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Lead sponsor | Peking University Cancer Hospital & Institute |
| Locations | Beijing, China |
| Start date | 2025-03-01 |
| NCT ID | NCT06849167 |
| Official listing | https://clinicaltrials.gov/study/NCT06849167 |