Metastatic (Stage IV) Non-squamous Non-small Cell Lung Cancer (Nsq-NSCLC) With Driver Gene Negativity, Untreated With Systemic Therapy
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of nanocrystalline medroxyprogesterone acetate for improving appetite and weight gain patients with non-small cell lung cancer (NSCLC) and cachexia and pre-cachexia. The enrolled patients were those with advanced NSCLC who had not received therapy, negative for driver genes and ineligible for curative treatment, and were planned to receive PD-1 inhibitors in combination with platinum-based chemotherapy.
Interventions
Nanocrystalline Megestrol Acetate Oral Suspension + Standard Therapy Nanocrystalline Megestrol Acetate Oral Suspension (125 mg/mL) was administered to the study group at 5 mL orally once daily (equivalent to 625 mg/day) until disease progression or completion of 12 weeks (maximum treatment duration: 12 weeks), whichever occurred first.
OTHERStandard Therapy
Standard Therapy
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Changchun GeneScience Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* ≥18 years at the time of enrollment. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. * Life expectancy ≥6 months. * Histologically or cytologically confirmed metastatic (stage IV) driver gene-negative non-squamous non-small cell lung cancer (NSCLC) that is unresectable and not amenable to curative therapy * Subjects with no prior systemic chemotherapy for metastatic non-small cell lung cancer (NSCLC).
Exclusion criteria
* Presence of any gastrointestinal absorption-impairing conditions (e.g., dysphagia, malabsorption, prior gastrectomy, or uncontrolled vomiting); current use of tube feeding/parenteral nutrition; or existence of anorexia nervosa, psychiatric disorder-induced anorexia, or pain-related feeding intolerance. * Driver gene-positive NSCLC or histologically/cytologically confirmed squamous cell-dominant NSCLC. * Patients with Cushing's syndrome, adrenal/pituitary insufficiency; poorly controlled diabetes mellitus. * Concurrent enrollment in another clinical trial, unless it is an observational/non-interventional study or the follow-up phase of an interventional trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of appetite improvement assessed by A/CS-12 (Anorexia/Cachexia Subscale of Functional Assessment of Anorexia/Cachexia Therapy) | Week 3 |
| Proportion of individuals with weight gain exceeding 5% relative to baseline | Week 12 |
Countries
China
Contacts
Primary ContactXiaorong Dong
Backup ContactPian Liu
Outcome results
None listed