AzTrials
AzTrials

Non Small Cell Lung CancerPhase 3NCT06828757

Clinical Study of Nanocrystalline Megestrol in Malnourished Patients With First-Line Non-Small Cell Lung Cancer

A Phase 3 study testing nanocrystalline megestrol oral suspension + PD-1/L1 inhibitor combined with chemotherapy and PD-1/L1 inhibitor combined with chemotherapy in people with Non Small Cell Lung Cancer, run by Hunan Province Tumor Hospital at 1 site in China.

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

This prospective interventional clinical study evaluates the efficacy of nanocrystalline megestrol combined with standard care in improving appetite and weight compared to standard care alone in first-line treatment of NSCLC. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
nanocrystalline megestrol oral suspension + PD-1/L1 inhibitor combined with chemotherapy and PD-1/L1 inhibitor combined with chemotherapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
1 siteChina
Study dates
1 May 2025to 30 Apr 2027
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • (1) Voluntarily sign a written ICF. (2) The age at the time of enrollment is ≥18 years old. (3) The physical fitness score of Eastern Tumor Cooperation Organization (ECOG) is 0-2.
  • The expected survival period is ≥6 months. (5) According to the 8th edition of the TNM stage classification of lung cancer with histological or cytologic evidence that cannot undergo complete surgical resection and cannot undergo radical synchronous/sequential chemoradiation and treatment ( ⅢB/ⅢC phase), metastatic (IV phase) NSCLC.
  • The subject has not received systemic chemotherapy for locally advanced or metastatic NSCLC. For patients who have received adjuvant/radiotherapy, neoadjuvant/radiotherapy or radical chemotherapy for locally advanced diseases, if the disease progression occurs after the end of the last treatment> After 6 months, you are eligible to participate in this study.
  • Subjects who had previously received PD-1/L1 inhibitors in the neoadjuvant stage were allowed to participate in this study after the investigator's evaluation and consent. Participants who had received PD-1/L1 inhibitors in the adjuvant stage or in the consolidation treatment stage after radical chemoradiotherapy were not allowed to participate in this study.
  • No EGFR-sensitive mutation or ALK gene translocation changes. For scaly NSCLC subjects with a history of smoking or who are still smoking, they are considered negative if the previous EGFR and ALK status are unknown.
  • There is at least one measurable lesion according to RECIST v1.1, and the lesion is suitable for repeated and accurate measurement.
Show all 11Show fewer
  • There is a high risk of malnutrition (nutrition risk screening 2002 score ≥3 points); (11) Determine good organ functions through the following requirements:
  • Hematology (no blood components and cell growth factor support therapy were used within 7 days before the start of the study): i. Absolute neutrophil value ANC ≥ 1.5 × 109/L (1,500/mm3); ii.Platelet count ≥ 100 × 109/L (100,000/mm3); iii.Hymoglobin ≥ 90 g/L. b) Kidney: i. Creatinine clearance* (CrCl) Calculated value ≥ 50 mL/min
  • The Cockcroft-Gault formula will be used to calculate CrCl (Cockcroft-Gault formula) CrCl (mL/min) = {(140 Age) × Weight (kg) × F/ (SCr (mg/dL) × 72) F=1 for males; F=0.85 for females; SCr = serum creatinine. ii. Urine protein ≤1 or 24 hours (h) Urine protein quantification < 1.0 g. c) Liver: i. serum total bilirubin (TBil) ≤ 1.5 × ULN; for patients with liver metastasis or evidence-confirmed/suspected Gilbert disease, TBil ≤ 3 × ULN ii. AST and ALT ≤ 2.5 × ULN; for patients with liver metastasis or evidence-confirmed/suspected Gilbert disease, TBil ≤ 3 × ULN; for patients with AST and ALT ≤ 2.5 × ULN; for patients with liver Metastatic patients, AST and ALT ≤ 5× ULN iii. Serum albumin (ALB) ≥28 g/L d) Coagulation function: i. International standardized ratio and activated partial thromboplastin time ≤ 1.5 × ULN (unless the patient is receiving anticoagulant treatment and the coagulation parameters (PT/INR and APTT) at screening are within the expected range of treatment with anticoagulant).
  • Cardiac function: i. Left ventricular ejaculation fraction (LVEF) ≥50%. (12) Female patients with fertility must undergo urine or serum pregnancy test within 3 days before the first medication (if the urine pregnancy test result cannot be confirmed to be negative, serum pregnancy test is required, and the serum pregnancy result shall prevail), and The result was negative. If a female patient with fertility has sex with an unsterilized male partner, the patient must adopt an acceptable contraceptive method from screening and must agree to the contraceptive method for continuous use within 120 days of the last dose of the study drug; Whether to stop contraceptive after this time point should be discussed with the researchers. If a male patient who is not sterilized has sex with a female partner with fertility, the patient must adopt an effective contraceptive method from the beginning of screening to the 120th day after the last dose; as to whether contraceptive is stopped after this time point, the patient should use the following: Researcher discussion.
  • The patient is willing and able to comply with the visits, treatment plans, laboratory tests specified in the schedule, and comply with other research requirements.

Who cannot join

  • (1) NSCLC diagnosed with EGFR sensitivity mutation or ALK gene translocation; Histologic presence of a small cell carcinoma component is not allowed to enroll.
  • Presence of dysphagia, malabsorption or uncontrollable vomiting and any other condition that affects gastrointestinal absorption; Ongoing tube feeding or parenteral nutrition; Presence of anorexia nervosa, anorexia due to psychiatric disorders, or pain that makes it difficult to eat.
  • Is taking or plans to take other appetite or weight increasing drugs, such as: adrenal corticosteroids (except for short-term use of dexamethasone during chemotherapy), androgens, progesterones, thalidomide, olanzapine, and anamolin or other appetite stimulants.
  • Patients with Cushing's syndrome, adrenal or pituitary insufficiency; Difficult to control diabetes patients.
  • Current imaging or clinical manifestations of gastrointestinal obstruction. (6) Active autoimmune disease requiring systemic therapy within the past two years (such as treatment with disease-modifying drugs, corticosteroids, immunosuppressants). Previous history of non-infectious pneumonitis/interstitial lung disease requiring systemic glucocorticoid therapy or current presence of non-infectious pneumonitis.
  • Current presence of uncontrolled comorbid diseases, including but not limited to decompensated cirrhosis, renal failure, uncontrolled metabolic disorders, severely active peptic ulcer disease, or gastritis, or psychiatric illness/social conditions that would limit the patient's compliance with study requirements or affect the patient's ability to provide written informed consent.
Show all 11Show fewer
  • Unstable angina, myocardial infarction, congestive heart failure (grade 2 and above determined by the functional classification of the New York Heart Association) or vascular disease (such as aortic aneurysm with risk of rupture) requiring hospitalization within 12 months prior to the first dose, or other cardiac damage that may affect the safety evaluation of the study drug (such as poorly controlled arrhythmia, myocardial ischemia); History of esophageal and gastric varices, severe ulcers, gastrointestinal perforation and/or fistulas, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to the first dose.
  • Any arterial thromboembolic event within 6 months prior to the first dose, venous thromboembolic event of NCI CTCAE version 5.0 grade 3 and above (requiring urgent medical intervention, such as pulmonary embolism or intracavenital embolism), transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy; Acute exacerbation of chronic obstructive pulmonary disease within 1 month prior to the first dose; Current hypertension with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg after treatment with oral antihypertensive medications.
  • Have a history of severe bleeding tendency or coagulation dysfunction; Significant clinically significant bleeding symptoms within 1 month prior to the first dose, including but not limited to gastrointestinal bleeding, hemoptysis (defined as coughing up or coughing up ≥1 teaspoon of fresh blood or small blood clots or only coughing up blood without sputum, patients with blood in sputum are allowed to be enrolled), nasal bleeding (excluding epistaxis bleeding and retracting rhinoblood).
  • Serious infection within 4 weeks prior to the first dose, including but not limited to comorbidities requiring hospitalization, sepsis or severe pneumonia; Active infection (excluding antiviral therapy for hepatitis B or C) that has received systemic anti-infective therapy within 2 weeks prior to the first dose.
  • Any previous or current disease, treatment, or laboratory abnormality that may confound the results of the study, affect the patient's full participation in the study, or may not be in the best interest of the patient.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • Yongchang Zhang

    Changsha, Hunan, 410013

Other trials in China

About this study

Official title: A Phase III Prospective, Randomized, Parallel-Controlled Clinical Study of Nanocrystalline Megestrol in Malnourished Patients With First-Line Non-Small Cell Lung Cancer

This prospective interventional clinical study evaluates the efficacy of nanocrystalline megestrol combined with standard care in improving appetite and weight compared to standard care alone in first-line treatment of NSCLC.

Read the detailed description

For patients with locally advanced or metastatic NSCLC who are not eligible for curative treatment-including those with non-squamous cell carcinoma harboring EGFR wild-type and ALK fusion-negative status-there remains a lack of evidence-based data on the association between improving high-risk malnutrition (NRS2002 score ≥3) and clinical benefit. Additionally, clinical research on nanocrystalline megestrol, a novel megestrol formulation, in the Chinese population is limited. Furthermore, data on its use in the first-line treatment of high-risk NSCLC with standard care are scarce. Integrating nanocrystalline megestrol into antitumor therapy to address malnutrition, enhance appetite, and promote weight gain represents a clinically meaningful and feasible approach. This strategy holds promise for improving quality of life while addressing the critical issue of survival benefit.

Being tested
nanocrystalline megestrol oral suspension + PD-1/L1 inhibitor combined with chemotherapy, PD-1/L1 inhibitor combined with chemotherapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • nanocrystalline megestrol oral suspension + PD-1/L1 inhibitor combined with chemotherapyDrug

    Oral suspension of nanocrystalline megestrol is taken orally once a day until disease progression or 12 weeks (maximum duration of 12 weeks) PD-1/L1 inhibitors combined with chemotherapy are given every 3 weeks for one dosing cycle.

  • PD-1/L1 inhibitor combined with chemotherapyDrug

    PD-1/L1 inhibitors combined with chemotherapy are given every 3 weeks for one dosing cycle.

Study groups in NCT06828757
Study groupRoleWhat they receive
Cohort 1ExperimentalTreatment cohort
Receives: Drug: nanocrystalline megestrol oral suspension + PD-1/L1 inhibitor combined with chemotherapy
Cohort 2ExperimentalControl cohort
Receives: Drug: PD-1/L1 inhibitor combined with chemotherapy

What is being measured

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

  1. Appetite improvement level

    Proportion of subjects with an improvement in appetite based on A/CS-12 during the treatment period; (An increase of ≥4 points or ≥37 points on the A/CS-12 scale is defined as an improvement in appetite)

    Measured: Time from first subject dose to study completion, or up to 36 month

  2. Weight improvement level

    Proportion of subjects with an increase from baseline in BMI during the treatment period.

    Measured: Time from first subject dose to study completion, or up to 36 month

Secondary outcomes (6)

  1. progression-free survival (PFS)

    defined as the duration from the start treatment to progression, or patient death

    Measured: Time from first subject dose to study completion, or up to 36 month

  2. Objective Response Rate (ORR)

    define as the proportion of subjects who have a complete response (CR) or a partial response (PR)

    Measured: Time from first subject dose to study completion, or up to 36 month

  3. L3 SMI

    Changes in L3 skeletal muscle index (L3 SMI).

    Measured: Time from first subject dose to study completion, or up to 36 month

  4. Nutritional status improvement level

    Assess the patient's nutritional improvement from treatment based on the Nutritional Risk Screening Score Short Form (NRS2002)

    Measured: Time from first subject dose to study completion, or up to 36 month

  5. The number of cycles of treatment completed

    Number of cycles from the start of the first treatment to the completion of the treatment

    Measured: Time from first subject dose to study completion, or up to 36 month

  6. The occurrence of treatment reduction

    Proportion of the number of patients with treatment reduction to the total number of patients from the first treatment

    Measured: Time from first subject dose to study completion, or up to 36 month

Timeline

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

  1. First posted14 Feb 2025
  2. Study start1 May 2025 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion30 Apr 2027 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
94 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06828757
Sponsor's protocol ID
NM2025
Status last verified
Feb 2025
First submitted
11 Feb 2025
Last updated
19 Feb 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing nanocrystalline megestrol oral suspension + PD-1/L1 inhibitor combined with chemotherapy and PD-1/L1 inhibitor combined with chemotherapy in people with Non Small Cell Lung Cancer, run by Hunan Province Tumor Hospital at 1 site in China.

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 11 inclusion and 11 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 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Appetite improvement level (time frame: Time from first subject dose to study completion, or up to 36 month). The study lists 2 primary outcomes in all. 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 NCT06828757.

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 19 Feb 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in