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Not yet recruiting NCT06961188

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

Phase III Interventional Metastatic (Stage IV) Non-squamous Non-small Cell Lung Cancer (Nsq-NSCLC) With Driver Gene Negativity Untreated With Systemic Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nano-crystalline Megestrol Acetate Oral Suspension, Standard Therapy.
Who it may be relevant to
Registry conditions: Metastatic (Stage IV) Non-squamous Non-small Cell Lung Cancer (Nsq-NSCLC) With Driver Gene Negativity, Untreated With Systemic Therapy. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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.

Overview

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

  • Drug Nano-crystalline Megestrol Acetate Oral Suspension
    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.
  • Other Standard Therapy
    Standard Therapy

Primary outcome measures

  • Proportion of appetite improvement assessed by A/CS-12 (Anorexia/Cachexia Subscale of Functional Assessment of Anorexia/Cachexia Therapy) [Time frame: Week 3]
  • Proportion of individuals with weight gain exceeding 5% relative to baseline [Time frame: Week 12]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan

Identifiers

NCT: NCT06961188 · Megaxia ES-NSCLC-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗