Nanocrystalline Megestrol Acetate in Concurrent Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer
Recruiting · NCT07150663 · Interventional (participants receive a specific treatment) · Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
Nano-crystalline Megestrol Acetate Oral SuspensionStandard Therapy
What this trial is about
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 take part
Age range
18 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Voluntarily provide written informed consent (ICF).
- Age ≥ 18 years at enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Expected survival ≥ 6 months.
- 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).
- Planned to receive radical concurrent chemoradiotherapy.
- Body mass index (BMI) ≤ 25.
- At least one measurable tumor lesion according to RECIST v1.1.
Exclusion criteria
- Presence of any condition affecting gastrointestinal absorption, such as difficulty swallowing, malabsorption, or uncontrollable vomiting; currently receiving tube feeding or parenteral nutrition; suffering from anorexia due to neurological or psychiatric disorders, or difficulty eating due to pain.
- Currently taking or planning to take other medications that increase appetite or body weight, such as corticosteroids (excluding short-term dexamethasone during chemotherapy), androgens, progestins, thalidomide, olanzapine, anamorelin, or other appetite stimulants.
- Patients with Cushing's syndrome, adrenal or pituitary insufficiency; patients with poorly controlled diabetes.
- Postmenopausal women with a history of abnormal vaginal bleeding within one year; premenopausal women with a history of abnormal endometrial thickening (\>15 mm) within one year.
- Current radiological or clinical evidence of gastrointestinal obstruction.
Where it is running
1 location listed.
- Tongji Hospital, TongjiMedical College, Huazhong University of Science and Technology - Wuhan, Hubei, China