Megestrol Acetate for First-Line Treatment of Malnourished Non-Small Cell Lung Cancer

Официальное название

A Prospective, Randomized, Parallel-Controlled Clinical Study of Megestrol Acetate Oral Suspension for First-Line Treatment of Malnourished Non-Small Cell Lung Cancer

Обзор

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.

Вмешательства

• Препарат 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 12 weeks Other: PD-1/L1 inhibitor combined with chemotherapy
• Другое PD-1/L1 inhibitor combined with chemotherapy
  PD-1/L1 inhibitor combined with chemotherapy

Первичные конечные точки

• change in body weight [Срок оценки: a 12-week period]

Вторичные конечные точки (4)

• Objective Response Rate (ORR) and 1-year Progression-Free Survival (PFS) rate [Срок оценки: 1-year period]
• change in appetite assessed by Anorexia/Cachexia Subscale 12 (A/CS-12) [Срок оценки: a 12-week period]
• change in lean body mass [Срок оценки: a 12-week period]
• Number of completed treatment cycles and occurrence of treatment dose reduction [Срок оценки: a 12-week period]

Критерии участия

Критерии включения

• Voluntarily provide written informed consent (ICF).
• Age ≥18 years at enrollment.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
• 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) ≤ 25.
• At least one measurable tumor lesion according to RECIST v1.1.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Rowland KM Jr, Loprinzi CL, Shaw EG, Maksymiuk AW, Kuross SA, Jung SH, Kugler JW, Tschetter LK, Ghosh C, Schaefer PL, Owen D, Washburn JH Jr, Webb TA, Mailliard JA, Jett JR. Randomized double-blind placebo-controlled trial of cisplatin and etoposide plus megestrol acetate/placebo in extensive-stage small-cell lung cancer: a North Central Cancer Treatment Group study. J Clin Oncol. 1996 Jan;14(1):1 PMID 8558188
• Deschamps B, Musaji N, Gillespie JA. Food effect on the bioavailability of two distinct formulations of megestrol acetate oral suspension. Int J Nanomedicine. 2009;4:185-92. doi: 10.2147/ijn.s6308. Epub 2009 Sep 10. PMID 19774117
• Li Y, Song CK, Kim MK, Lim H, Shen Q, Lee DH, Yang SG. Nanomemulsion of megestrol acetate for improved oral bioavailability and reduced food effect. Arch Pharm Res. 2015 Oct;38(10):1850-6. doi: 10.1007/s12272-015-0604-9. Epub 2015 Apr 18. PMID 25893430
• Treger S, Ackerman S, Kaplan V, Ghanem S, Nadir Y. Progestin type affects the increase of heparanase level and procoagulant activity mediated by the estrogen receptor. Hum Reprod. 2021 Jan 1;36(1):61-69. doi: 10.1093/humrep/deaa263. PMID 33306105
• Fedotcheva TA. Clinical Use of Progestins and Their Mechanisms of Action: Present and Future (Review). Sovrem Tekhnologii Med. 2021;13(1):93-106. doi: 10.17691/stm2021.13.1.11. Epub 2021 Feb 28. PMID 34513071
• Trestini I, Gkountakos A, Carbognin L, Avancini A, Lanza M, Molfino A, Friso S, Corbo V, Tortora G, Scarpa A, Milella M, Bria E, Pilotto S. Muscle derangement and alteration of the nutritional machinery in NSCLC. Crit Rev Oncol Hematol. 2019 Sep;141:43-53. doi: 10.1016/j.critrevonc.2019.06.007. Epub 2019 Jun 15. PMID 31228648

Идентификаторы

NCT: NCT07477808 · 2026-HNCA-Nourish-NSCLC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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