Nanocrystalline Megestrol Acetate in Concurrent Chemoradiotherapy for Locally Advanced Non
This study is a prospective, randomized, parallel-controlled clinical trial, primarily aimed at evaluating the efficacy and safety of Nanocrystalline Megestrol Acetate combined with standard therapy, compared with placebo combined with standard therapy, in improving appetite and body weight during concurrent chemoradio
| Condition(s) | Non-small Cell Lung Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | This study is a prospective, randomized, parallel-controlled clinical trial, primarily aimed at evaluating the efficacy and safety of Nanocrystalline Megestrol Acetate combined with standard therapy, compared with placebo combined with standard therapy, in improving appetite and body weight during concurrent chemoradiotherapy for patients with locally advanced non-small cell lung cancer. |
| Who can participate | Inclusion Criteria: 1. Voluntarily provide written informed consent (ICF). 2. Age ≥ 18 years at enrollment. 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. 4. Expected survival ≥ 6 months. 5. Histologically or cytologically confirmed, unresectable or inoperable locally advanced (stage III) non-small cell lung cancer (adenocarcinoma or squamous cell carcinoma) according to the 8th edition of the TNM classification by the International Association for the Study of Lung Cancer (IASLC) and the American Joint Committee on Cancer (AJCC). 6. Planned to receive radical concurrent chemoradiotherapy. 7. Body mass index (BMI) ≤ 25. 8. At least one measurable tumor lesion according to RECIST v1.1. Exclusion Criteria: 1. Presence of any condition affecting gastrointestinal |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Lead sponsor | Changchun GeneScience Pharmaceutical Co., Ltd. |
| Locations | Wuhan, Hubei, China |
| Start date | 2025-08-20 |
| NCT ID | NCT07150663 |
| Official listing | https://clinicaltrials.gov/study/NCT07150663 |