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Weight-Loss drug for lung cancer patients put to the test

NCT ID NCT07477808

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a liquid form of megestrol acetate (a drug that stimulates appetite) can help malnourished people with non-small cell lung cancer gain weight while they receive standard chemotherapy. About 116 participants will be randomly assigned to get either the drug plus standard treatment or standard treatment alone. The main goal is to see if body weight improves over 12 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
megestrol acetate oral suspension
What this could lead to
If it works, this could provide a way to help lung cancer patients maintain or gain weight during chemotherapy, improving their strength and quality of life.
What could go wrong
This is an early-stage trial with only 116 participants, so results may not apply to everyone. The drug may cause side effects like blood clots or fluid retention, and weight gain may not improve cancer outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 116 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

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