Clinical trial · Interventional
Clinical Study on Nanocrystalline Megestrol Acetate for Appetite Improvement and Weight Gain in Pre-Cachexia and Cachexia Stages Key Terminology Analysis
Clinical Study on Nanocrystalline Megestrol Acetate for Appetite Improvement and Weight Gain in First-Line Non-Squamous Non-Small Cell Lung Cancer Patients During Pre-Cachexia and Cachexia Stages.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic (Stage IV) Non-squamous Non-small Cell Lung Cancer (Nsq-NSCLC) With Driver Gene Negativity | — | UNRESOLVED | — |
| Untreated With Systemic Therapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nano-crystalline Megestrol Acetate Oral Suspension | Drug | — | UNRESOLVED |
| Standard Therapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Nanocrystalline Megestrol Acetate Oral Suspension
- interventionNames
- Drug: Nano-crystalline Megestrol Acetate Oral Suspension
- Other: Standard Therapy
- type
- ACTIVE_COMPARATOR
- label
- No-Treatment Control
- interventionNames
- Other: Standard Therapy
Primary outcomes (2)
- measure
- Proportion of appetite improvement assessed by A/CS-12 (Anorexia/Cachexia Subscale of Functional Assessment of Anorexia/Cachexia Therapy)
- timeFrame
- Week 3
- measure
- Proportion of individuals with weight gain exceeding 5% relative to baseline
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available