Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
Study NCT ID:
NCT06828757
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-19
First Post:
2025-02-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study of Nanocrystalline Megestrol in Malnourished Patients With First-Line Non-Small Cell Lung Cancer
Sponsor:
Hunan Province Tumor Hospital
Organization:
Study Overview
Official Title:
A Phase III Prospective, Randomized, Parallel-Controlled Clinical Study of Nanocrystalline Megestrol in Malnourished Patients With First-Line Non-Small Cell Lung Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This prospective interventional clinical study evaluates the efficacy of nanocrystalline megestrol combined with standard care in improving appetite and weight compared to standard care alone in first-line treatment of NSCLC.
Detailed Description:
For patients with locally advanced or metastatic NSCLC who are not eligible for curative treatment-including those with non-squamous cell carcinoma harboring EGFR wild-type and ALK fusion-negative status-there remains a lack of evidence-based data on the association between improving high-risk malnutrition (NRS2002 score ≥3) and clinical benefit. Additionally, clinical research on nanocrystalline megestrol, a novel megestrol formulation, in the Chinese population is limited. Furthermore, data on its use in the first-line treatment of high-risk NSCLC with standard care are scarce. Integrating nanocrystalline megestrol into antitumor therapy to address malnutrition, enhance appetite, and promote weight gain represents a clinically meaningful and feasible approach. This strategy holds promise for improving quality of life while addressing the critical issue of survival benefit.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: