RecruitingPhase 3NCT07150663

Nanocrystalline Megestrol Acetate in Concurrent Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer

A Prospective, Randomized, Parallel-Controlled Clinical Study of Nanocrystalline Megestrol Acetate in Concurrent Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer


Sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Enrollment

134 participants

Start Date

Aug 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a prospective, randomized, parallel-controlled clinical trial, primarily aimed at evaluating the efficacy and safety of Nanocrystalline Megestrol Acetate combined with standard therapy, compared with placebo combined with standard therapy, in improving appetite and body weight during concurrent chemoradiotherapy for patients with locally advanced non-small cell lung cancer.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called nanocrystalline megestrol acetate can help prevent weight loss in patients with locally advanced non-small cell lung cancer (NSCLC) who are undergoing concurrent chemotherapy and radiation. Weight loss during cancer treatment is common and worsens outcomes. **You may be eligible if...** - You are 18 years old or older - You have confirmed stage III (locally advanced) non-small cell lung cancer that cannot be surgically removed - You are planned to receive chemotherapy and radiation at the same time (concurrent chemoradiotherapy) - Your BMI is 25 or below - You have at least one measurable tumor and your expected survival is at least 6 months - Your overall health status is reasonable (ECOG 0–2) **You may NOT be eligible if...** - You have significant digestive or absorption problems - You have had prior treatment for this lung cancer - You have other serious health conditions making this treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNano-crystalline Megestrol Acetate Oral Suspension

Nanocrystalline Megestrol Acetate Oral Suspension Nanocrystalline Megestrol Acetate Oral Suspension (125 mg/mL) was administered to the study group at 5 mL orally once daily (equivalent to 625 mg/day) until disease progression or completion of 8 weeks (maximum treatment duration: 8 weeks), whichever occurred first.

OTHERStandard Therapy

Standard Therapy


Locations(1)

Tongji Hospital, TongjiMedical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

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NCT07150663


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