Lung CancerPhase 2NCT07092137
Nano-crystalline Megestrol Acetate for Anorexia-Cachexia Syndrome in Advanced Lung Cancer
A Phase 2 study testing Nano-crystalline Megestrol Acetate Oral Suspension in people with Lung Cancer and Cachexia-Anorexia Syndrome, run by Guangzhou Institute of Respiratory Disease.
Trial summary
Patients with advanced lung cancer are a high-risk population for cancer-related anorexia-cachexia syndrome (CACS). Meanwhile, the adverse reactions of chemotherapy and immunotherapy potentially exacerbate the occurrence and progression of CACS. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer, Cachexia-Anorexia Syndrome
- What is being tested?
- Nano-crystalline Megestrol Acetate Oral Suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2025to 10 Oct 2027
- 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 must meet all the following criteria to be eligible for study enrollment:
- Inclusion criteria for advanced lung cancer:
- Patients with histologically or cytologically confirmed locally advanced (Stage ⅢC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) that cannot be completely resected surgically or treated with radical chemoradiotherapy, according to the 8th edition of the TNM staging classification for lung cancer by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification.
- Patients with histologically or cytologically confirmed small cell lung cancer (SCLC) and diagnosed as extensive-stage SCLC based on the 8th edition of AJCC staging or the Veterans Administration Lung Group (VALG) criteria (excluding mixed small cell lung cancer).
- Subjects who have not received prior systemic chemotherapy for metastatic disease. Subjects who received adjuvant/neoadjuvant chemotherapy or radical concurrent/sequential chemoradiotherapy with curative intent for non-metastatic disease are eligible if disease progression occurs >6 months after the end of the last treatment.
- At least one measurable tumor lesion according to RECIST v1.1.
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- Criteria for pre-cachexia or cachexia stage:
- Pre-cachexia diagnostic criteria (all three must be met):
- Unintentional weight loss ≤5% in the past 6 months;
- ② Systemic inflammation (CRP >5 mg/L);
- ③ Decreased appetite (FAACT-A/CS 12 score ≤37).
- Fearon diagnostic criteria for cachexia stage (any one of the following combined with decreased appetite [FAACT-A/CS 12 score ≤37] or systemic inflammation [CRP >5 mg/L]):
- Unintentional weight loss >5% in the past 6 months; ② Weight loss >2% when BMI <18.5 kg/m².
- General inclusion requirements:
- Good compliance and signed informed consent form.
- Age 18-75 years, regardless of gender.
- ECOG performance status 0-2.
- Life expectancy ≥6 months.
- Good organ function:
- Hematological: Neutrophils ≥1.5×10⁹/L, hemoglobin ≥9 g/dL, platelets ≥100×10⁹/L.
- Liver function: Bilirubin ≤1.5×ULN (patients with known Gilbert disease and serum bilirubin ≤3×ULN are eligible); AST and ALT ≤2.5×ULN (if liver metastasis is present, AST and ALT ≤5×ULN); alkaline phosphatase ≤3×ULN (if liver or bone metastasis is present, ALP ≤5×ULN); albumin ≥3 g/dL.
- Coagulation function: International normalized ratio (INR), prothrombin time (PT), or activated partial thromboplastin time (aPTT) ≤1.5×ULN.
- Renal function: Creatinine clearance rate ≥60 mL/min (calculated by Cockcroft-Gault formula).
- Urine protein ≤1+ or 24-hour urine protein <1.0 g.
- Cardiac function: Left ventricular ejection fraction (LVEF) ≥50%.
- Female patients of childbearing potential must have a negative urine or serum pregnancy test within 3 days before the first drug administration (if the urine test is inconclusive, a serum test is required, with the serum result as the standard). If a female patient of childbearing potential has sexual activity with an unsterilized male partner, she must use an acceptable contraceptive method from screening and agree to continue contraception for 120 days after the last administration of the study drug. Whether to discontinue contraception after this period should be discussed with the investigator. Male patients who are not sterilized and have sexual activity with female partners of childbearing potential must use effective contraception from screening to 120 days after the last administration. Whether to discontinue contraception after this period should be discussed with the investigator.
Who cannot join
- (1) Cancer-specific exclusion criteria:
- Active or untreated CNS metastases (e.g., brain or leptomeningeal metastases) confirmed by CT or magnetic resonance (MRI) evaluation during screening and prior imaging. Patients who have received treatment for brain or leptomeningeal metastases, have been stable for ≥2 months, and have discontinued systemic hormonal therapy (>10 mg/d prednisone or equivalent) >4 weeks before randomization may participate.
- Uncontrolled tumor-related pain. c) Thromboembolic disease, ascites, or lower limb edema within the past 6 months.
- History of malignant tumors other than lung cancer within 5 years before randomization, except for malignancies with negligible risk of metastasis or death [e.g., expected 5-year overall survival rate >90%] and expected to be cured after treatment, such as appropriately treated cervical in situ carcinoma, basal or squamous cell skin cancer, localized prostate cancer treated with radical surgery, and ductal carcinoma in situ treated with radical surgery.
- Unresolved toxicity from prior antitumor therapy, defined as failure to recover to NCI CTCAE v5.0 grade 0 or 1 (except alopecia) or to the levels specified in the inclusion/exclusion criteria.
- General medical exclusion criteria:
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- Women who are pregnant, lactating, or planning to become pregnant during the study.
- Patients with hepatitis B (known HBsAg-positive and HBV DNA ≥1000 cps/ml or 200 IU/ml or ≥ the upper limit of normal at each study center) or hepatitis C:
- ● For patients with a history of HBV infection, HBV DNA testing must be performed, and they are eligible only if HBV DNA is negative (HBV DNA <1000 cps/ml or 200 IU/ml or below the upper limit of normal).
- Among patients with positive HCV antibody, only those with negative HCV RNA by polymerase chain reaction (PCR) may participate.
- Patients with positive human immunodeficiency virus (HIV) test results.
- Receipt of major surgery (excluding diagnostic surgery) within 28 days before randomization, or expected to undergo major surgery during the study.
- Significant cardiovascular diseases, such as heart disease defined by the New York Heart Association (class II or higher), myocardial infarction within 3 months before randomization, unstable arrhythmia, unstable angina, cerebrovascular accident, or transient ischemic attack. Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction <50% must receive the optimal stable treatment regimen as determined by their attending physician, with consultation from a cardiologist if necessary.
- Severe infection within 4 weeks before the first drug administration, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; active infection requiring systemic anti-infective therapy within 2 weeks before the first drug administration (excluding antiviral therapy for hepatitis B or C).
- Medication-related exclusion criteria:
- <!-- -->
- Any condition affecting gastrointestinal absorption, such as dysphagia, malabsorption, uncontrollable vomiting; patients with difficulty in food intake or requiring enteral or parenteral nutrition support; anorexia nervosa, anorexia due to mental illness, or difficulty in eating due to pain.
- Current or planned use of other appetite or weight-increasing medications, such as adrenal corticosteroids (except short-term dexamethasone use during chemotherapy), androgens, progestins, thalidomide, olanzapine, anamorelin, or other appetite stimulants.
- Patients with Cushing's syndrome, adrenal or pituitary insufficiency; poorly controlled diabetes; current hypertension with systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg despite oral antihypertensive treatment.
- History of esophageal-gastric varices, severe ulcers, gastrointestinal perforation and/or fistula, gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months before the first drug administration.
- Known allergy to any component of the study drug.
- Other circumstances deemed unsuitable by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Nano-crystalline Megestrol Acetate for Anorexia-Cachexia in Advanced Lung Cancer: A Randomized, Double-Blind, Multicenter Study
Patients with advanced lung cancer are a high-risk population for cancer-related anorexia-cachexia syndrome (CACS). Meanwhile, the adverse reactions of chemotherapy and immunotherapy potentially exacerbate the occurrence and progression of CACS. CACS seriously affects the quality of life of patients with advanced lung cancer, significantly shortens the overall survival (OS) and progression-free survival (PFS), forming a vicious cycle. A number of previous studies have shown that combined supportive therapies such as megestrol acetate during chemotherapy or concurrent chemoradiotherapy for advanced tumor patients is a clinically meaningful and feasible treatment model in clinical practice. However, the efficacy and optimal treatment timing of combination with current first-line immunochemotherapy regimens remain unclear. Although mechanistic studies have shown that anti-cachexia therapy may synergistically enhance the efficacy of immunotherapy, relevant clinical research evidence is lacking.
Therefore, this study hypothesizes that the combination of first-line immunochemotherapy regimen and nano-crystalline megestrol acetate can improve the clinical benefits of patients with advanced lung cancer. It is planned to enroll patients with advanced lung cancer who present with anorexia-cachexia, and administer nano-crystalline megestrol acetate intervention (nano-crystalline megestrol acetate or its placebo control) during first-line immunochemotherapy. The changes in body weight relative to the baseline, as well as the impact on survival benefits and quality of life of patients, will be detected. In China, megestrol acetate is mainly available in two dosage forms: oral suspension and dispersible tablets. The oral suspension of megestrol acetate adopts nano-crystal technology (referred to as nano-crystalline megestrol acetate), which reduces the particle size of megestrol acetate and improves bioavailability. Previous randomized controlled studies have shown that it is superior to non-nano-crystal dosage forms in improving body weight.
- Conditions
- Lung Cancer, Cachexia-Anorexia Syndrome
- Being tested
- Nano-crystalline Megestrol Acetate Oral Suspension, Nano-crystalline Megestrol Acetate Oral Suspension placebo
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nano-crystalline Megestrol Acetate Oral SuspensionDrug
Nano-crystalline Megestrol Acetate+PD-(L)1 inhibitor (Q3W, until PD) + chemotherapy (based on guidelines)
Nano-crystalline Megestrol Acetate Oral Suspension placeboOther
Nano-crystalline Megestrol Acetate placebo+PD-(L)1 inhibitor (Q3W, until PD) + chemotherapy (based on guidelines)
| Study group | Role | What they receive |
|---|---|---|
| Nanocrystalline megestrol acetate+immunochemotherapy | Experimental | Not described Receives: Drug: Nano-crystalline Megestrol Acetate Oral Suspension |
| Nanocrystalline megestrol acetate placebo+immunochemotherapy | Placebo comparator | Not described Receives: Other: Nano-crystalline Megestrol Acetate Oral Suspension placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants with a body weight increase of >5% relative to the baseline.
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (9)
appetite
The proportion of participants with a better appetite >5% relative to the baseline. Participants report a score on a scale FAACT-A/CS 12，with 4 higher scores mean a better outcome.
Measured: From enrollment to the end of treatment at 12 week
QOL
Participants report a score on a scale EORTC QLQ-C30.
Measured: From enrollment to the end of treatment at 12 week
Anxiety and depression
Participants report a score on a scale HADS
Measured: From enrollment to the end of treatment at 12 week
PFS in 6 months and 12 months
Measured: From enrollment to the end of treatment at 6 months and 12 months
Treatment compliance ( relative dose intensity, RDI)
Relative Dose Intensity (RDI): The ratio of the actual administered dose intensity to the standard planned dose intensity, usually expressed as a percentage (%).
Measured: From enrollment to the end of treatment at 12 weeks
L3-SMI
The Hounsfield unit (HU) limits used for assessing skeletal muscle mass ranged from -29 to +150 HU. The muscle area was normalised for height, resulting in a ratio (cm2/m2) known as the L3 skeletal mass index (L3 SMI).
Measured: From enrollment to the end of treatment at 12 weeks
Inflammatory indicators (CRP, IL-1, IL-6, TNF-α, etc.)
Measured: From enrollment to the end of treatment at 12 weeks
Nutritional indicators (prealbumin, albumin, hemoglobin)
Measured: From enrollment to the end of treatment at 12 weeks
ACTH、VIP、SSTR
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start10 Oct 2025 (estimated)
- Primary completion10 Oct 2026 (estimated)
- Study completion10 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Chengzhi, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07092137
- Sponsor's protocol ID
- MGA-25-0701
- Status last verified
- Jul 2025
- First submitted
- 7 Jul 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nano-crystalline Megestrol Acetate for Anorexia-Cachexia in Advanced Lung Cancer: A Randomized, Double-Blind, Multicenter Study
- ClinicalTrials.gov ID
- NCT07092137
- Acronym / sponsor ID
- MGA-25-0701
- Conditions
- Lung Cancer, Cachexia-Anorexia Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- 10 Oct 2025 (estimated)
- Primary completion
- 10 Oct 2026 (estimated)
- Study completion
- 10 Oct 2027 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with advanced lung cancer are a high-risk population for cancer-related anorexia-cachexia syndrome (CACS). Meanwhile, the adverse reactions of chemotherapy and immunotherapy potentially exacerbate the occurrence and progression of CACS. CACS seriously affects the quality of life of patients with advanced lung cancer, significantly shortens the overall survival (OS) and progression-free survival (PFS), forming a vicious cycle. A number of previous studies have shown that combined supportive therapies such as megestrol acetate during chemotherapy or concurrent chemoradiotherapy for advanced tumor patients is a clinically meaningful and feasible treatment model in clinical practice. However, the efficacy and optimal treatment timing of combination with current first-line immunochemotherapy regimens remain unclear. Although mechanistic studies have shown that anti-cachexia therapy may synergistically enhance the efficacy of immunotherapy, relevant clinical research evidence is lacking.
Therefore, this study hypothesizes that the combination of first-line immunochemotherapy regimen and nano-crystalline megestrol acetate can improve the clinical benefits of patients with advanced lung cancer. It is planned to enroll patients with advanced lung cancer who present with anorexia-cachexia, and administer nano-crystalline megestrol acetate intervention (nano-crystalline megestrol acetate or its placebo control) during first-line immunochemotherapy. The changes in body weight relative to the baseline, as well as the impact on survival benefits and quality of life of patients, will be detected. In China, megestrol acetate is mainly available in two dosage forms: oral suspension and dispersible tablets. The oral suspension of megestrol acetate adopts nano-crystal technology (referred to as nano-crystalline megestrol acetate), which reduces the particle size of megestrol acetate and improves bioavailability. Previous randomized controlled studies have shown that it is superior to non-nano-crystal dosage forms in improving body weight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nanocrystalline megestrol acetate+immunochemotherapy | Experimental | Drug: Nano-crystalline Megestrol Acetate Oral Suspension |
| Nanocrystalline megestrol acetate placebo+immunochemotherapy | Placebo comparator | Other: Nano-crystalline Megestrol Acetate Oral Suspension placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Inclusion criteria for advanced lung cancer:
- Criteria for pre-cachexia or cachexia stage:
- ② Systemic inflammation (CRP >5 mg/L);
- ③ Decreased appetite (FAACT-A/CS 12 score ≤37).
- General inclusion requirements:
Key exclusion criteria (22 listed)
- (1) Cancer-specific exclusion criteria:
- ● For patients with a history of HBV infection, HBV DNA testing must be performed, and they are eligible only if HBV DNA is negative (HBV DNA <1000 cps/ml or 200 IU/ml or below the upper limit of normal).
- <!-- -->
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nano-crystalline Megestrol Acetate Oral SuspensionNano-crystalline Megestrol Acetate+PD-(L)1 inhibitor (Q3W, until PD) + chemotherapy (based on guidelines) | Drug | Nanocrystalline megestrol acetate+immunochemotherapy |
| Nano-crystalline Megestrol Acetate Oral Suspension placeboNano-crystalline Megestrol Acetate placebo+PD-(L)1 inhibitor (Q3W, until PD) + chemotherapy (based on guidelines) | Other | Nanocrystalline megestrol acetate placebo+immunochemotherapy |
Primary outcome
The proportion of participants with a body weight increase of >5% relative to the baseline.
Time frame: From enrollment to the end of treatment at 12 weeks
9 secondary outcomes
appetite
Time frame: From enrollment to the end of treatment at 12 week
QOL
Time frame: From enrollment to the end of treatment at 12 week
Anxiety and depression
Time frame: From enrollment to the end of treatment at 12 week
PFS in 6 months and 12 months
Time frame: From enrollment to the end of treatment at 6 months and 12 months
Treatment compliance ( relative dose intensity, RDI)
Time frame: From enrollment to the end of treatment at 12 weeks
L3-SMI
Time frame: From enrollment to the end of treatment at 12 weeks
Inflammatory indicators (CRP, IL-1, IL-6, TNF-α, etc.)
Time frame: From enrollment to the end of treatment at 12 weeks
Nutritional indicators (prealbumin, albumin, hemoglobin)
Time frame: From enrollment to the end of treatment at 12 weeks
ACTH、VIP、SSTR
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nano-crystalline Megestrol Acetate Oral Suspension in people with Lung Cancer and Cachexia-Anorexia 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 26 inclusion and 22 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 29 Jul 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. Some participants in this study may receive a placebo. 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 xiaohong xie (+8613632326736, gyxxh@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of participants with a body weight increase of >5% relative to the baseline. (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2025.