Status:
NOT_YET_RECRUITING
Clinical Study on Nanocrystalline Megestrol Acetate for Appetite Improvement and Weight Gain in Pre-Cachexia and Cachexia Stages Key Terminology Analysis
Lead Sponsor:
Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions:
Metastatic (Stage IV) Non-squamous Non-small Cell Lung Cancer (Nsq-NSCLC) With Driver Gene Negativity
Untreated With Systemic Therapy
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
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) ...
Eligibility Criteria
Inclusion
- ≥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
- 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.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT06961188
Start Date
June 1 2025
End Date
December 31 2027
Last Update
May 7 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000