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

Not Applicable

Recruiting

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Nano-crystalline Megestrol Acetate Oral Suspension; Other: Standard Therapy

• Registration Number: NCT07150663
• Lead Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study Start: 2025-08-20
• Study First Submitted: 2025-08-25
• Study First Submitted QC: 2025-08-25
• Last Update Submitted: 2025-08-31
• Study First Posted: 2025-09-02
• Last Update Posted: 2025-09-08
• Primary Completion: 2027-06-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

1. Voluntarily provide written informed consent (ICF).
2. Age ≥ 18 years at enrollment.
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
4. Expected survival ≥ 6 months.
5. Histologically or cytologically confirmed, unresectable or inoperable locally advanced (stage III) non-small cell lung cancer (adenocarcinoma or squamous cell carcinoma) according to the 8th edition of the TNM classification by the International Association for the Study of Lung Cancer (IASLC) and the American Joint Committee on Cancer (AJCC).
6. Planned to receive radical concurrent chemoradiotherapy.
7. Body mass index (BMI) ≤ 25.
8. At least one measurable tumor lesion according to RECIST v1.1.

Exclusion Criteria

1. Presence of any condition affecting gastrointestinal absorption, such as difficulty swallowing, malabsorption, or uncontrollable vomiting; currently receiving tube feeding or parenteral nutrition; suffering from anorexia due to neurological or psychiatric disorders, or difficulty eating due to pain.
2. Currently taking or planning to take other medications that increase appetite or body weight, such as corticosteroids (excluding short-term dexamethasone during chemotherapy), androgens, progestins, thalidomide, olanzapine, anamorelin, or other appetite stimulants.
3. Patients with Cushing's syndrome, adrenal or pituitary insufficiency; patients with poorly controlled diabetes.
4. Postmenopausal women with a history of abnormal vaginal bleeding within one year; premenopausal women with a history of abnormal endometrial thickening (>15 mm) within one year.
5. Current radiological or clinical evidence of gastrointestinal obstruction.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nanocrystalline Megestrol Acetate Oral Suspension+ Standard Therapy	Nano-crystalline Megestrol Acetate Oral Suspension	-
Nanocrystalline Megestrol Acetate Oral Suspension+ Standard Therapy	Standard Therapy	-
Placebo+ Standard Therapy	Standard Therapy	-

Primary Outcome Measures

Name	Time	Method
Proportion of appetite decrease assessed by A/CS-12 (Anorexia/Cachexia Subscale of Functional Assessment of Anorexia/Cachexia Therapy)	over an 8-week period
Proportion of individuals with weight loss exceeding 5% relative to baseline	over an 8-week period

Trial Locations

Locations (1)

Tongji Hospital, TongjiMedical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China