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Extensive-stage Small Cell Lung Cancer (ES-SCLC)Phase 2NCT06909383

Nanocrystalline Megestrol Acetate for the Treatment of Anorexia-Cachexia Syndrome in Extensive-Stage Small Cell Lung Cancer: A Prospective, Open-Label, Single-Arm Phase II Clinical Study

A Phase 2 study testing Nanocrystalline megestrol acetate in people with Extensive-stage Small Cell Lung Cancer (ES-SCLC) and Cancer - Associated Anorexia - Cachexia Syndrome, run by Guangzhou Institute of Respiratory Disease.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Patients with extensive-stage small cell lung cancer are a high-risk group for cancer cachexia and anorexia. Meanwhile, the adverse reactions of chemotherapy and immunotherapy potentially exacerbate the occurrence and development of cancer cachexia and anorexia. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Nanocrystalline megestrol acetate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
No sites listed yet
Study dates
1 Jun 2025to 31 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who have been confirmed by histological or cytological examination to have small cell lung cancer (SCLC), and who have been identified as having extensive-stage small cell lung cancer based on the 8th edition of the AJCC staging system or the Veterans Administration Lung Group (VALG) criteria (excluding patients with combined small cell lung cancer).
  • The subjects have not received systemic chemotherapy for metastatic diseases in the past. For subjects who have previously received adjuvant/neoadjuvant chemotherapy aimed at cure for non-metastatic diseases, or radical concurrent or sequential chemoradiotherapy, if the disease progression occurs more than 6 months after the end of the last treatment, they are eligible to participate in this study.
  • According to RECIST v1.1, there is at least one measurable tumor lesion. Meet the diagnostic criteria for the pre-cachexia or cachexia stage. -

Who cannot join

  • Cancer-specific exclusion criteria:
  • Active or untreated CNS metastases (e.g., brain or leptomeningeal metastases) determined by CT or magnetic resonance imaging (MRI) evaluation during screening and previous imaging evaluations. Patients who have previously received treatment for brain or leptomeningeal metastases, have been stable for ≥ 2 months, and have discontinued systemic hormonal therapy (> 10 mg/day of prednisone or equivalent) for > 4 weeks before randomization may participate in the study.
  • Uncontrolled tumor-related pain;
  • Thromboembolic disease, ascites, or lower extremity edema within the past 6 months;
  • A history of malignant tumors other than lung cancer within 5 years before random assignment, except for malignant tumors with a negligible risk of metastasis or death [e.g., with an expected 5-year overall survival rate > 90%] and those expected to be cured after treatment, such as appropriately treated cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer treated with radical surgery, and ductal carcinoma in situ treated with radical surgery;
  • Persistent toxicity from previous anti-tumor treatment that has not been resolved. "Not resolved" is defined as not having recovered to grade 0 or 1 according to NCI CTCAE version 5.0 (excluding alopecia) or not having recovered to the level specified in the inclusion/exclusion criteria.
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  • General medical exclusion criteria:
  • Women who are pregnant, lactating, or planning to become pregnant during the study period;
  • Patients with hepatitis B (known to be positive for HBV surface antigen HBsAg and with HBV DNA detected at each study center ≥ 1000 cps/ml or 200 IU/ml or ≥ the upper limit of the normal value) or hepatitis C:
  • For patients with a previous history of hepatitis B virus (HBV) infection, HBV deoxyribonucleic acid (DNA) testing must be performed on this group of patients. Only those with a negative HBV DNA result (HBV DNA < 1000 cps/ml or 200 IU/ml or below the upper limit of the normal value) are eligible to participate in this study;
  • Among patients with a positive hepatitis C virus (HCV) antibody, only those with a negative polymerase chain reaction (PCR) HCV ribonucleic acid (RNA) result can participate in this study.
  • Patients with a positive test result for human immunodeficiency virus (HIV);
  • Those who have undergone major surgery (excluding diagnostic surgery) within 28 days before random assignment, or are expected to undergo major surgery during the study period;
  • Significant cardiovascular diseases, such as heart diseases defined by the New York Heart Association (Class II or higher), myocardial infarction occurred within 3 months before random assignment, unstable arrhythmia, unstable angina pectoris, cerebrovascular accident or transient ischemic attack; Patients known to have coronary artery disease, congestive heart failure that does not meet the above criteria, or with a left ventricular ejection fraction < 50% must receive the optimal stable treatment regimen considered by the attending physician, and consultation with a cardiologist is advisable if necessary;
  • Severe infections occurred within 4 weeks before the first administration, including but not limited to those with comorbidities requiring hospitalization, sepsis, or severe pneumonia; Active infections (excluding antiviral treatment for hepatitis B or hepatitis C) for which systemic anti-infective treatment was received within 2 weeks before the first administration.
  • Exclusion criteria related to drug use:
  • Any condition that affects gastrointestinal absorption, such as dysphagia, malabsorption, uncontrollable vomiting, etc.; Patients with difficulty in food intake or those who require enteral or parenteral nutritional support; Patients with anorexia nervosa, anorexia caused by mental illness, or difficulty in eating due to pain.
  • Currently taking or planning to take other drugs that increase appetite or body weight, such as adrenal corticosteroids (except for short-term use of 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; Patients with current hypertension whose systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg after treatment with oral antihypertensive drugs.
  • A history of esophageal-gastric varices, severe ulcers, gastrointestinal perforation and/or fistula, a history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months before the first administration.
  • Known allergy to any component of the study drug.
  • Other situations that the investigator deems unsuitable.
  • -

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Chengzhi Zhou contact

86+13560351186

About this study

Patients with extensive-stage small cell lung cancer are a high-risk group for cancer cachexia and anorexia. Meanwhile, the adverse reactions of chemotherapy and immunotherapy potentially exacerbate the occurrence and development of cancer cachexia and anorexia. Cancer cachexia and anorexia also severely affect the quality of life of patients with extensive-stage small cell lung cancer, significantly shortening their overall survival (OS) and progression-free survival (PFS), thus forming a vicious cycle.

Numerous previous studies have shown that for patients with advanced tumors, the combination of supportive treatments such as megestrol acetate during chemotherapy or concurrent chemoradiotherapy is a treatment mode with clinical significance and practical feasibility in clinical practice. However, the efficacy and the optimal treatment timing of its combination with the current first-line immunochemotherapy regimen remain unclear. Although mechanistic studies have shown that anti-cachexia treatment may synergistically enhance the efficacy of immunotherapy, there is a lack of relevant clinical research evidence.

Being tested
Nanocrystalline megestrol acetate
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nanocrystalline megestrol acetateDrug

    Nanocrystalline megestrol acetate

Study groups in NCT06909383
Study groupRoleWhat they receive
Nanocrystalline megestrol acetate+immunochemotherapyExperimentalNot described
Receives: Drug: Nanocrystalline megestrol acetate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The proportion of subjects with a body weight increase of more than 5% relative to the baseline

    Measured: at the 12th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2025
  2. Study start1 Jun 2025 (estimated)
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06909383
Sponsor's protocol ID
CROC-25-01
Status last verified
Mar 2025
First submitted
27 Mar 2025
Last updated
3 Apr 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nanocrystalline megestrol acetate in people with Extensive-stage Small Cell Lung Cancer (ES-SCLC) and Cancer - Associated Anorexia - Cachexia Syndrome, run by Guangzhou Institute of Respiratory Disease.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chengzhi Zhou (86+13560351186), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of subjects with a body weight increase of more than 5% relative to the baseline (time frame: at the 12th week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06909383.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.

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