NCT07092137

Nano-crystalline Megestrol Acetate for Anorexia-Cachexia Syndrome in Advanced Lung Cancer

Nano-crystalline Megestrol Acetate for Anorexia-Cachexia in Advanced Lung Cancer: A Randomized, Double-Blind, Multicenter Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Guangzhou Institute of Respiratory Disease · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Patients with advanced lung cancer are a high-risk population for cancer-related anorexia-cachexia syndrome (CACS). Meanwhile, the adverse reactions of chemotherapy and immunotherapy potentially exacerbate the occurrence and progression of CACS. CACS seriously affects the quality of life of patients with advanced lung cancer, significantly shortens the overall survival (OS) and progression-free survival (PFS), forming a vicious cycle. A number of previous studies have shown that combined supportive therapies such as megestrol acetate during chemotherapy or concurrent chemoradiotherapy for advanced tumor patients is a clinically meaningful and feasible treatment model in clinical practice. However, the efficacy and optimal treatment timing of combination with current first-line immunochemotherapy regimens remain unclear. Although mechanistic studies have shown that anti-cachexia therapy may synergistically enhance the efficacy of immunotherapy, relevant clinical research evidence is lacking. Therefore, this study hypothesizes that the combination of first-line immunochemotherapy regimen and nano-crystalline megestrol acetate can improve the clinical benefits of patients with advanced lung cancer. It is planned to enroll patients with advanced lung cancer who present with anorexia-cachexia, and administer nano-crystalline megestrol acetate intervention (nano-crystalline megestrol acetate or its placebo control) during first-line immunochemotherapy. The changes in body weight relative to the baseline, as well as the impact on survival benefits and quality of life of patients, will be detected. In China, megestrol acetate is mainly available in two dosage forms: oral suspension and dispersible tablets. The oral suspension of megestrol acetate adopts nano-crystal technology (referred to as nano-crystalline megestrol acetate), which reduces the particle size of megestrol acetate and improves bioavailability. Previous randomized controlled studies have shown that it is superior to non-nano-crystal dosage forms in improving body weight.

Conditions

• Lung Cancer
• Cachexia-Anorexia Syndrome

Interventions

Type	Name	Description
DRUG	Nano-crystalline Megestrol Acetate Oral Suspension	Nano-crystalline Megestrol Acetate+PD-(L)1 inhibitor (Q3W, until PD) + chemotherapy (based on guidelines)
OTHER	Nano-crystalline Megestrol Acetate Oral Suspension placebo	Nano-crystalline Megestrol Acetate placebo+PD-(L)1 inhibitor (Q3W, until PD) + chemotherapy (based on guidelines)

Timeline

• Start date: 2025-10-10
• Primary completion: 2026-10-10
• Completion: 2027-10-10
• First posted: 2025-07-29
• Last updated: 2025-07-29

Regulatory

• FDA-regulated drug study