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

NCT06961188 | Not Yet Recruiting Phase 3

• 1 other identifier: Megaxia ES-NSCLC-01
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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) 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

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

Outcome Measures

Primary Outcomes (2)

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

  Week 3

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

  Week 12

Study Arms (2)

Nanocrystalline Megestrol Acetate Oral Suspension

EXPERIMENTAL

Drug: Nano-crystalline Megestrol Acetate Oral Suspension; Other: Standard Therapy

No-Treatment Control

ACTIVE COMPARATOR

Other: Standard Therapy

Interventions

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.

Nanocrystalline Megestrol Acetate Oral Suspension

Standard Therapy OTHER

Standard Therapy

Nanocrystalline Megestrol Acetate Oral Suspension; No-Treatment Control

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator

Study Sites (1)

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

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Xiaorong Dong

CONTACT

13986252286; xhzzdxr@126.com

Pian Liu

CONTACT

15629090146; liupianamazing@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 7, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 7, 2025

Record last verified: 2025-04

Locations

CN (1)