Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06961188

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Metastatic (Stage IV) Non-squamous Non-small Cell Lung Cancer (Nsq-NSCLC) With Driver Gene Negativity Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Untreated With Systemic Therapy

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

Location contact

Xiaorong Dong

CONTACT

[email protected]

13986252286

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nano-crystalline Megestrol Acetate Oral Suspension

Drug

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.

Standard therapy

Other

Standard Therapy

Primary outcomes

  1. Proportion of appetite improvement assessed by A/CS-12 (Anorexia/Cachexia Subscale of Functional Assessment of Anorexia/Cachexia Therapy)

    Time frame: Week 3

  2. Proportion of individuals with weight gain exceeding 5% relative to baseline

    Time frame: Week 12

Study contacts

Contact information is provided by the study sponsor or research team.

Pian Liu

CONTACT

[email protected]

15629090146

Xiaorong Dong

CONTACT

[email protected]

13986252286

Sponsors and collaborators

Lead sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Industry

Collaborators

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 7, 2025
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.