NCT07477808尚未招募3 期
A Prospective, Randomized, Parallel-Controlled Clinical Study of Megestrol Acetate Oral Suspension for First-Line Treatment of Malnourished Non-Small Cell Lung Cancer
Hunan Province Tumor Hospital0 个研究点目标入组 116 人开始时间: 2026年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 116
- 主要终点
- change in body weight
研究概览
简要总结
This study is a prospective, randomized, parallel-controlled clinical trial, primarily aimed at evaluating the level of body weight improvement of megestrol acetate combined with standard treatment compared with standard treatment in the first-line treatment of non-small cell lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily provide written informed consent (ICF).
- •Age ≥18 years at enrollment.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-
- •Expected survival ≥6 months.
- •According to the 8th edition of the Lung Cancer TNM Staging Classification by the International Association for the Study of Lung Cancer (IASLC) and the American Joint Committee on Cancer (AJCC), subjects have histologically or cytologically confirmed locally advanced (Stage ⅢB/ⅢC) or metastatic (Stage IV) NSCLC that cannot be completely resected by surgery and cannot receive radical concurrent/sequential chemoradiotherapy.
- •Subjects have not received systemic chemotherapy for locally advanced or metastatic NSCLC before. For patients who have previously received adjuvant chemotherapy/radiotherapy, neoadjuvant chemotherapy/radiotherapy for non-metastatic diseases with curative intent, or radical chemoradiotherapy for locally advanced diseases, they are eligible to participate in this study if disease progression occurs more than 6 months after the end of the last treatment.
- •Subjects who have previously received PD-1/L1 inhibitors in the neoadjuvant phase are allowed to participate in this study after evaluation and approval by the investigator; subjects who have previously received PD-1/L1 inhibitors in the adjuvant phase or the consolidation treatment phase after radical chemoradiotherapy are not allowed to participate in this study.
- •No EGFR sensitive mutation or ALK gene translocation. For squamous NSCLC subjects with a smoking history or current smoking, if the previous EGFR and ALK status is unknown, it is considered negative.
- •Body mass index (BMI) ≤
- •At least one measurable tumor lesion according to RECIST v1.1.
排除标准
- •Diagnosis of NSCLC with EGFR sensitive mutation or ALK gene translocation; subjects with small cell carcinoma components in histology.
- •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.
研究组 & 干预措施
Nanocrystalline Megestrol Acetate + PD-1/L1 inhibitor + chemotherapy
Experimental
Nanocrystalline Megestrol Acetate Oral Suspension+ PD-1/L1 inhibitor combined with chemotherapy
干预措施: Nanocrystalline Megestrol Acetate Oral Suspension (Drug)
PD-1/L1 inhibitor + chemotherapy
Placebo Comparator
PD-1/L1 inhibitor combined with chemotherapy
干预措施: PD-1/L1 inhibitor combined with chemotherapy (Other)
结局指标
主要结局
change in body weight
时间窗: a 12-week period
To evaluate the change in body weight of megestrol acetate combined with standard treatment compared with standard treatment in the first-line treatment of NSCLC.
次要结局
- Objective Response Rate (ORR) and 1-year Progression-Free Survival (PFS) rate(1-year period)
- change in appetite assessed by Anorexia/Cachexia Subscale 12 (A/CS-12)(a 12-week period)
- change in lean body mass(a 12-week period)
- Number of completed treatment cycles and occurrence of treatment dose reduction(a 12-week period)
研究者
Yongchang Zhang
DR
Hunan Province Tumor Hospital
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