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

March 20, 2026 updated by: Yongchang Zhang, Hunan Province Tumor Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

116

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nanocrystalline Megestrol Acetate + PD-1/L1 inhibitor + chemotherapy
Nanocrystalline Megestrol Acetate Oral Suspension+ PD-1/L1 inhibitor combined with chemotherapy
Drug: 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
Placebo Comparator: PD-1/L1 inhibitor + chemotherapy
PD-1/L1 inhibitor combined with chemotherapy
Other: PD-1/L1 inhibitor combined with chemotherapy
PD-1/L1 inhibitor combined with chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in body weight
Time Frame: 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.
a 12-week period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) and 1-year Progression-Free Survival (PFS) rate
Time Frame: 1-year period
To evaluate the Objective Response Rate (ORR) and 1-year Progression-Free Survival (PFS) rate (based on RECIST v1.1) of megestrol acetate combined with standard treatment compared with standard treatment in the first-line treatment of NSCLC.
1-year period
change in appetite assessed by Anorexia/Cachexia Subscale 12 (A/CS-12)
Time Frame: a 12-week period
To evaluate the change in appetite assessed by Anorexia/Cachexia Subscale 12 (A/CS-12) of megestrol acetate combined with standard treatment compared with standard treatment in the first-line treatment of NSCLC. An increase of ≥ 4 points in the A/CS-12 scale, or an A/CS-12 scale score of ≥ 37 points, indicates appetite improvement. If the above criteria are not met, it indicates no appetite improvement.
a 12-week period
change in lean body mass
Time Frame: a 12-week period
To evaluate the change in lean body mass of megestrol acetate combined with standard treatment
a 12-week period
Number of completed treatment cycles and occurrence of treatment dose reduction
Time Frame: a 12-week period
To evaluate the number of completed treatment cycles and the occurrence of treatment dose reduction of megestrol acetate plus standard therapy versus standard therapy alone as first-line treatment for non-small cell lung cancer (NSCLC).
a 12-week period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hunan Province Tumor Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

March 12, 2026

First Submitted That Met QC Criteria

March 12, 2026

First Posted (Actual)

March 17, 2026

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-HNCA-Nourish-NSCLC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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