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

NCT ID: NCT07150663

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-20
• Study Completion Date: 2027-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Nanocrystalline Megestrol Acetate Oral Suspension+ Standard Therapy

Group Type: EXPERIMENTAL

Nano-crystalline Megestrol Acetate Oral Suspension

Intervention Type: 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.

Standard Therapy

Intervention Type: OTHER

Standard Therapy

Placebo+ Standard Therapy

Group Type: PLACEBO_COMPARATOR

Standard Therapy

Intervention Type: OTHER

Standard Therapy

Interventions

Nano-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.

Intervention Type: DRUG

Standard Therapy

Standard Therapy

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tongji Hospital

OTHER

Sponsor Role: collaborator

Changchun GeneScience Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

qian Chu

Role: CONTACT

qianchu@tjh.tjmu.edu.cn

13212760751

Facility Contacts

qian Chu

Role: primary

qianchu@tjh.tjmu.edu.cn

13212760751

Other Identifiers

Megaxia CRT-NSCLC-01

Identifier Type: -

Identifier Source: org_study_id