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

NCT07150663 | Recruiting Phase 3

• 1 other identifier: Megaxia CRT-NSCLC-01
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Nanocrystalline Megestrol Acetate Oral Suspension+ Standard Therapy

EXPERIMENTAL

Drug: Nano-crystalline Megestrol Acetate Oral Suspension; Other: Standard Therapy

Placebo+ Standard Therapy

PLACEBO COMPARATOR

Other: Standard Therapy

Interventions

Nano-crystalline Megestrol Acetate Oral Suspension DRUG

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.

Nanocrystalline Megestrol Acetate Oral Suspension+ Standard Therapy

Standard Therapy OTHER

Standard Therapy

Nanocrystalline Megestrol Acetate Oral Suspension+ Standard Therapy; Placebo+ Standard Therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily provide written informed consent (ICF).
• Age ≥ 18 years at enrollment.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
• Expected survival ≥ 6 months.
• 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).
• Planned to receive radical concurrent chemoradiotherapy.
• Body mass index (BMI) ≤ 25.
• At least one measurable tumor lesion according to RECIST v1.1.

You may not qualify if:

• 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.
• 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.
• Patients with Cushing's syndrome, adrenal or pituitary insufficiency; patients with poorly controlled diabetes.
• 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.
• Current radiological or clinical evidence of gastrointestinal obstruction.

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead
• Tongji Hospital: collaborator

Study Sites (1)

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

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

qian Chu

CONTACT

13212760751; qianchu@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 2, 2025
• Study Start: August 20, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-08

Locations

CN (1)