drugset / Trial / NCT05834413
Clinical Study on the Prevention of Driver Gene Negative Ib-IIIb Lung Cancer Recurrence and Metastasis by Staged Chinese Herbal Medicine Combined With Chemotherapy and Immune Checkpoint Inhibitors
Recruiting
367 enrolled
Shanghai University of Traditional Chinese Medicine
Fudan University · collabRuijin Hospital · collabShanghai Chest Hospital · collabShanghai Pulmonary Hospital, Shanghai, China · collabShanghai Zhongshan Hospital · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This project adopts a prospective, multicenter, randomized controlled clinical study to investigate the treatment of TCM in postoperative patients with driver gene negative lung cancer, according to two phases of postoperative adjuvant therapy: (i) chemotherapy phase immunotherapy phase. In this study, 367 patients (183 in the control group and 184 in the trial group) will be observed over 4 years, and the quality of life, toxic effects and safety of this therapy will be investigated. This study will provide evidence-based evidence for the establishment and optimization of a new model of postoperative staged TCM with adjuvant chemo-immunotherapy for lung cancer.
Timeline
- Start
- 2023-05-01
- Primary completion
- 2027-06-30
- Completion
- 2027-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FeiPingFang | Unknown | — | Oral |
| Subject | HeWeiYangXueFang | Unknown | — | Oral |
| Background | Atezolizumab | Monoclonal antibody | — | — |
| Background | Camrelizumab | Monoclonal antibody | — | — |
| Background | Carboplatin | Small molecule | — | — |
| Background | Cisplatin | Other / unclassified | — | — |
| Background | Docetaxel | Small molecule | — | — |
| Background | Dupilumab | Monoclonal antibody | — | — |
| Background | Durvalumab | Monoclonal antibody | — | — |
| Background | Gemcitabine | Small molecule | — | — |
| Background | Nivolumab | Monoclonal antibody | — | — |
| Background | Paclitaxel | Small molecule | — | — |
| Background | Pembrolizumab | Monoclonal antibody | — | — |
| Background | Pemetrexed | Small molecule | — | — |
| Background | Sintilimab | Monoclonal antibody | — | — |
| Background | Tislelizumab | Monoclonal antibody | — | — |
| Background | Vincristine | Small molecule | — | — |