Phase 2 Clinical Trial for Nano-crystalline Megestrol Acetate in Anorexia-Cachexia in Advanced Lung Cancer

Strategic Insights -

A Phase 2 clinical trial has been initiated by the Guangzhou Institute of Respiratory Disease to study the efficacy of nano-crystalline megestrol acetate in patients with anorexia-cachexia syndrome (CACS) in advanced lung cancer. The trial aims to enroll 116 participants from the USA and investigate whether the combination of first-line immunochemotherapy regimens and nano-crystalline megestrol acetate can improve clinical benefits, including body weight, survival benefits, and quality of life.

Key Takeaways:

  • The trial targets patients with advanced lung cancer and anorexia-cachexia, aiming to improve clinical benefits through the combination of immunochemotherapy regimens and nano-crystalline megestrol acetate.
  • Previous studies have shown that combined supportive therapies, such as megestrol acetate, can be a clinically meaningful treatment model in clinical practice.
  • However, the efficacy and optimal treatment timing of combination with current first-line immunochemotherapy regimens remain unclear, and relevant clinical research evidence is lacking.
  • The trial will enroll patients with advanced lung cancer who present with anorexia-cachexia and administer nano-crystalline megestrol acetate intervention during first-line immunochemotherapy.
  • The changes in body weight relative to the baseline and the impact on survival benefits and quality of life of patients will be detected.
  • The trial has been registered on ClinicalTrials.gov with ID NCT07092137.

Statistics:

  • 116 participants will be enrolled in the trial from the USA.
  • The trial is currently not open for recruiting.
  • The study is a Phase 2, randomized, double-blind, multicenter study.

Sources:

  • ClinicalTrials.govallest (https://clinicaltrials.gov/study/NCT07092137)