NCT06828757

Clinical Study of Nanocrystalline Megestrol in Malnourished Patients With First-Line Non-Small Cell Lung Cancer

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 94 (estimated)
• Sponsor: Hunan Province Tumor Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	nanocrystalline megestrol oral suspension + PD-1/L1 inhibitor combined with chemotherapy	Oral suspension of nanocrystalline megestrol is taken orally once a day until disease progression or 12 weeks (maximum duration of 12 weeks) PD-1/L1 inhibitors combined with chemotherapy are given every 3 weeks for one dosing cycle.
DRUG	PD-1/L1 inhibitor combined with chemotherapy	PD-1/L1 inhibitors combined with chemotherapy are given every 3 weeks for one dosing cycle.

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-12-31
• Completion: 2027-04-30
• First posted: 2025-02-14
• Last updated: 2025-02-19

Locations

1 site across 1 country: China