drugset / Trial / NCT03391869
Nivolumab and Ipilimumab With or Without Local Consolidation Therapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This phase III trial studies how well nivolumab and ipilimumab works with or without local consolidation therapy in treating patients with stage IV non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Local consolidation therapy, such as surgery or radiation therapy, may improve survival outcomes in patients with non-small cell lung cancer. It is not yet known whether giving nivolumab and ipilimumab with local consolidation therapy works better than nivolumab and ipilimumab alone in treating patients with stage IV non-small cell lung cancer.
Timeline
- Start
- 2017-12-29
- Primary completion
- 2027-03-31
- Completion
- 2027-03-31
Publications
- Altan M, Li R, Li Z, Chen R, Sheshadri A, Tran HT, Little L, Baguley J, Sinson J, Vokes N, Gandhi S, Antonoff MB, Swisher SG, Lizee G, Reuben A, Heymach JV, Zhang J. High peripheral T cell diversity is associated with lower risk of toxicity and superior response to dual immune checkpoint inhibitor therapy in patients with metastatic NSCLC. J Immunother Cancer. 2024 Dec 25;12(12):e008950. doi: 10.1136/jitc-2024-008950.
- Altan M, Li QZ, Wang Q, Vokes NI, Sheshadri A, Gao J, Zhu C, Tran HT, Gandhi S, Antonoff MB, Swisher S, Wang J, Byers LA, Abdel-Wahab N, Franco-Vega MC, Wang Y, Lee JJ, Zhang J, Heymach JV. Distinct patterns of auto-reactive antibodies associated with organ-specific immune-related adverse events. Front Immunol. 2023 Dec 12;14:1322818. doi: 10.3389/fimmu.2023.1322818. eCollection 2023.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 3 mg/kg | Intravenous |