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

Phase 3

Not yet recruiting

• Conditions: Metastatic (Stage IV) Non-squamous Non-small Cell Lung Cancer (Nsq-NSCLC) With Driver Gene Negativity; Untreated With Systemic Therapy
• Interventions: Drug: Nano-crystalline Megestrol Acetate Oral Suspension; Other: Standard Therapy

• Registration Number: NCT06961188
• Lead Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-29
• Study First Submitted QC: 2025-04-29
• Last Update Submitted: 2025-04-29
• Study First Posted: 2025-05-07
• Last Update Posted: 2025-05-07
• Study Start: 2025-06-01
• Primary Completion: 2027-06-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 174

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nanocrystalline Megestrol Acetate Oral Suspension	Nano-crystalline Megestrol Acetate Oral Suspension	-
Nanocrystalline Megestrol Acetate Oral Suspension	Standard Therapy	-
No-Treatment Control	Standard Therapy	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China