Status:
RECRUITING
Nanocrystalline Megestrol Acetate in Concurrent Chemoradiotherapy for Locally Advanced Non-Small Cell Lung Cancer
Lead Sponsor:
Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Tongji Hospital
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
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, ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT07150663
Start Date
August 20 2025
End Date
December 31 2027
Last Update
September 8 2025
Active Locations (1)
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1
Tongji Hospital, TongjiMedical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000