Clinical Study on Nanocrystalline Megestrol Acetate for Appetite Improvement and Weight Gain in Pre-Cachexia and Cachexia Stages Key Terminology Analysis

Launched by CHANGCHUN GENESCIENCE PHARMACEUTICAL CO., LTD. · Apr 29, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called nanocrystalline megestrol acetate, which aims to help improve appetite and promote weight gain in patients with advanced non-small cell lung cancer (NSCLC) who are experiencing early stages of weight loss, known as pre-cachexia and cachexia. The trial is specifically for adults aged 18 and older with metastatic (stage IV) NSCLC that has not been treated before and does not have certain genetic markers, making them ineligible for curative therapies. Participants will be those who are set to receive a specific type of chemotherapy after joining the study.

To be eligible for this trial, participants need to have a life expectancy of at least six months and a good level of daily functioning, as indicated by a performance status score of 0-2. However, individuals with certain health issues that could affect absorption of the medication or those who have already received treatment for their cancer will not be included. The trial is not yet recruiting participants, but if someone qualifies, they can expect to be monitored for how well the medication helps with their appetite and weight, alongside their cancer treatment.

Gender

ALL

Eligibility criteria

• 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.