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

NCT07477808 | Not Yet Recruiting Phase 3

• 1 other identifier: 2026-HNCA-Nourish-NSCLC
• Study Type: interventional
• Target: 116
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• change in body weight

  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.

  a 12-week period

Secondary Outcomes (4)

• 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

Study Arms (2)

Nanocrystalline Megestrol Acetate + PD-1/L1 inhibitor + chemotherapy

EXPERIMENTAL

Nanocrystalline Megestrol Acetate Oral Suspension+ PD-1/L1 inhibitor combined with chemotherapy

Drug: Nanocrystalline Megestrol Acetate Oral Suspension

PD-1/L1 inhibitor + chemotherapy

PLACEBO COMPARATOR

PD-1/L1 inhibitor combined with chemotherapy

Other: PD-1/L1 inhibitor combined with chemotherapy

Interventions

Nanocrystalline Megestrol Acetate Oral Suspension DRUG

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

Nanocrystalline Megestrol Acetate + PD-1/L1 inhibitor + chemotherapy

PD-1/L1 inhibitor combined with chemotherapy OTHER

PD-1/L1 inhibitor combined with chemotherapy

PD-1/L1 inhibitor + chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hunan Province Tumor Hospital: lead

Related Publications (6)

• 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):135-41. doi: 10.1200/JCO.1996.14.1.135.

  PMID: 8558188 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

yong chang Zhang

CONTACT

13873123436; zhangyongchang@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 17, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL