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

GeneScience Pharmaceuticals (GenSci)

Status and phase: Enrolling; Phase 3

Conditions: Non-small Cell Lung Cancer

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07150663

Megaxia CRT-NSCLC-01

Details and patient eligibility

About

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.

Enrollment: 134 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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134 participants in 2 patient groups, including a placebo group

Nanocrystalline Megestrol Acetate Oral Suspension+ Standard Therapy

Experimental group

Treatment:

Other: Standard Therapy

Drug: Nano-crystalline Megestrol Acetate Oral Suspension

Placebo+ Standard Therapy

Placebo Comparator group

Treatment:

Other: Standard Therapy