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SCLC, Extensive StagePhase 2NCT06793228

Nanocrystalline Megestrol + Immunochemo As 1st-Line for ES-SCLC Cachexia

A Phase 2 study testing Nanocrystalline Megestrol Acetate, Tislelizumab and PTOC in people with SCLC, Extensive Stage, run by Henan Cancer Hospital at 4 sites 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 study hypothesizes that nanocrystalline megestrol acetate can improve the cachexia condition in patients and enhance the efficacy of immunochemotherapy regimens. It plans to enroll patients newly diagnosed with extensive-stage small-cell lung cancer (ES-SCLC) who are in the pre-cachexia or cachexia stage of the… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
SCLC, Extensive Stage
What is being tested?
Nanocrystalline Megestrol Acetate, Tislelizumab and PTOC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
4 sitesChina
Study dates
15 Jan 2025to 15 Dec 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Good compliance and voluntary signing of a written informed consent form (ICF).
  • Age at enrolment ≥18 years, ≤75 years, and gender-neutral (patients >75 years old will be enrolled in the RWS cohort).
  • Eastern Cooperative Oncology Group (ECOG) physical status score of 0-2 (patients with PS 3 and above due to oncological factors can be enrolled in the CU cohort or RWS cohort).
  • Expected survival ≥ 6 months.
  • Patients with histologically or cytologically confirmed small cell lung cancer (SCLC) and confirmed extensive stage small cell lung cancer based on AJCC 8th edition staging or the American Legion Lung Cancer Association (VALG) Stage II staging method (excluding mixed small cell lung cancer).
  • Subjects have not received prior systemic systemic chemotherapy for metastatic disease. Subjects with prior adjuvant/neoadjuvant chemotherapy or radical synchronous or sequential radiotherapy for non-metastatic disease with curative intent are eligible for this study if disease progression occurred >6 months after the end of the last treatment.
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  • Have at least one measurable tumour lesion according to RECIST v1.1.
  • Meet the diagnostic criteria for premalignant or malignant stage. Diagnostic criteria for pre-Cachexia stage
  • Referring to the 2016 ESPEN consensus on terminology, the following conditions are also met:
  • Maximum weight loss <5% relative to baseline 6 months ago;
  • Anorexia (presence of anorexia complaints or anorexia/malignant condition subscale FAACT-A/CS score ≤37); (iii) Serum C-reactive protein CRP ≥ 5 mg/L. Diagnostic criteria for cachexia Any one of the following conditions combined with loss of appetite or systemic inflammatory response.
  • Involuntary weight loss >5% in the last 6 months. ② Weight loss >2% when BMI <18.5kg ③ Weight loss >2% with muscle loss.
  • Determine good organ function by the following requirements:
  • Routine haematology (no supportive therapy with any blood components and cell growth factors within 7 days prior to initiation of study treatment): i. Absolute neutrophil ANC ≥ 1.5 × 10^9/L (1,500/mm3); ii. Platelet count ≥ 100 × 10^9/L (100,000/mm3); and iii. Haemoglobin ≥ 90 g/L.
  • Renal function: i. Creatinine clearance* (CrCl) calculated ≥ 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-hour (h) urine protein quantitatively < 1.0 g. c) Liver function: i. serum total bilirubin (TBil) ≤ 1.5 × upper limit of normal (ULN); TBil ≤ 3 × ULN for patients with liver metastases or evidence of confirmed/suspected Gilbert's disease.
  • AST and ALT ≤ 2.5 × ULN; for patients with liver metastases, AST and ALT ≤ 5 × ULN iii. serum albumin (ALB) ≥ 28 g/L d) Coagulation: International Normalised Ratio and Activated Partial Thromboplastin Time ≤ 1.5 × ULN (unless the patient is on anticoagulant therapy and the coagulation parameters (PT/INR and APTT) are in the expected range for treatment with anticoagulants at screening).
  • Cardiac function: left ventricular ejection fraction (LVEF) ≥50%.
  • Lung function indices 1st second forced expiratory volume (FEV1) >1L or >30% of predicted value, and lung carbon monoxide diffusion function (DLCO) >30% of predicted value;
  • Female patients of childbearing potential must have a urine or serum pregnancy test (if the urine pregnancy test result is not confirmed negative, a serum pregnancy test is required, and the serum pregnancy result will be used as the basis for the negative result) performed within 3 days prior to the first dose of the drug, and the result is negative. If a female patient of childbearing potential engages in sexual intercourse with an unsterilised male partner, the patient must be using an acceptable method of contraception from the start of screening and must agree to continue to use the adopted method of contraception for a period of 120 days after the last dose of study drug; the decision on whether or not to discontinue contraception after this time point should be discussed with the investigator. If an unsterilised male patient has sexual intercourse with a female partner of childbearing potential, the patient must use an effective method of contraception from the start of screening until the 120th day after the last dose of study medication; discontinuation of contraception after this time point should be discussed with the investigator.
  • The patient is willing and able to comply with the schedule of visits, treatment regimens, laboratory tests, and other requirements of the study.

Who cannot join

  • Subjects meeting any of the exclusion criteria baseline will be excluded from the study:
  • Main exclusion criteria
  • Presence of malignant conditions other than those caused by oncological etiology such as chronic respiratory failure requiring home oxygen support, chronic obstructive pulmonary disease, chronic and persistent congestive heart failure, acquired immunodeficiency syndrome, uncontrollable thyroid disease.
  • Presence of any condition that interferes with gastrointestinal absorption such as dysphagia, malabsorption, previous history of gastrectomy, or uncontrollable vomiting; being on tube feeding or parenteral nutrition; presence of anorexia nervosa, anorexia due to psychiatric disorders, or pain that makes it difficult to eat.
  • Being on other appetite or weight-increasing medications such as: adrenocortical steroids (except for short-term use of dexamethasone during chemotherapy), androgens, progesterone analogues, thalidomide, and anamorelin or other appetite stimulants.
  • Use of any proprietary or herbal medicine used for cancer control within 14 days prior to the first dose of study drug.
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  • Pre-existing (within 3 years) or current other malignancies, except cured localised tumours (e.g. basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, etc.).
  • Concurrent enrolment in another clinical study, unless it is an observational, non-interventional clinical study or a follow-up period of an interventional study.
  • Previous treatment with any other antibody or drug specifically targeting the T-cell co-stimulatory or checkpoint pathway such as anti-PD-1, PD-L1 or CTLA-4 therapy.
  • Presence of esophagogastric fundal varices, severe ulcers, history of gastrointestinal perforation and/or fistulae, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), history of intra-abdominal abscess or acute gastrointestinal bleeding, thromboembolic disease, ascites, or lower extremity oedema in the 6 months prior to the first dose.
  • Current uncontrolled co-morbidities including, but not limited to, decompensated cirrhosis, renal failure, uncontrolled metabolic disorders, severe active peptic ulcer disease or gastritis, or psychiatric/social conditions that would limit the patient's ability to comply with the requirements of the study or affect the patient's ability to provide written informed consent.
  • Pre-existing history of myocarditis, cardiomyopathy, or malignant arrhythmia. Unstable angina requiring hospitalisation, myocardial infarction, congestive heart failure (aortic aneurysm of grade 2 and at risk of rupture as determined by the New York Heart Association functional class), or other cardiac impairment (e.g., poorly controlled arrhythmia, myocardial ischaemia) that may interfere with the evaluation of the safety of the investigational drug, within 6 months prior to the first dose of study drug.
  • Severe chronic or active infection (including tuberculosis infection, etc.) requiring systemic antibacterial, antifungal, or antiviral therapy ≤ 14 days prior to the first dose of study drug.
  • Patients with active molluscum contagiosum metastases, or brain metastases that are not well controlled; Patients with stable treated brain metastases may be enrolled at the discretion of the investigator; Patients with untreated, asymptomatic brain metastases may be enrolled at the judgement of the investigator, but will require regular brain imaging of the disease site.
  • Major surgical procedure or serious trauma within 30 days prior to the first dose of the drug or major surgical procedure planned within 30 days of the first dose of the drug.
  • Live or live attenuated vaccine administered within 30 days prior to the first dose or planned to be administered during the study period; inactivated vaccines are permitted.
  • Known hypersensitivity to any component of the study drug.
  • Females who are pregnant or breastfeeding.
  • Patients who, in the judgement of the investigator, may have poor compliance with the procedures and requirements of the study; patients who, in the judgement of the investigator, have any condition that endangers patient safety or interferes with the assessment of the study (e.g., patients treated with radiotherapy/synchrotron radiotherapy during the immunochemotherapy phase, except during the maintenance phase).
  • Secondary exclusion criteria (CU cohort may be included)
  • Active autoimmune disease requiring systemic therapy within the last two years, active or previous history of definite inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis or chronic diarrhoea).
  • Patients with Cushing's syndrome, adrenal or pituitary insufficiency; patients with difficult-to-control diabetes mellitus; and current hypertension with systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg treated with oral antihypertensive medications.
  • Previous non-infectious pneumonia requiring systemic glucocorticoid therapy or current non-infectious pneumonia combined with mild to moderate interstitial pneumonia, inactive interstitial pneumonia.
  • 4) Presence of unmitigated toxicity from prior antineoplastic therapy, with unmitigated defined as failure to recover to NCI CTCAE version 5.0 grade 0 or 1 (except alopecia areata) or failure to recover to levels specified in the inclusion/exclusion criteria.
  • 5) History of known allogeneic organ transplantation and allogeneic haematopoietic stem cell transplantation; history of organ or haematopoietic stem cell transplantation requiring immunosuppression.
  • 6) Patients with chronic hepatitis B or chronic hepatitis B virus carriers with HBV DNA ≥500 IU/mL (2500 copies/mL), or hepatitis C patients.
  • 7) Other circumstances as determined by the investigator.

Trial locations and contacts

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

Qiming Wang contact

+86-0371-65588421

qimingwang1006@126.com

Shuxiang Ma contact

+86-0371-65588421

zlyymashuxiang4175@zzu.edu.cn

China4 sites

  • The First Affiliated Hospital of Henan University of Science and Technolog

    Luoyang, Henan

    Zhang, 18138080603@163.com

  • Xinxiang Central Hospital

    Xinxiang, Henan, 450052

    Zhang, 800-555-5555, 15637359110@139.com

  • Henan cancer hospital,

    Zhengzhou, Henan, 450052

    Shuxiang Ma, +86-0371-65588421, zlyymashuxiang4175@zzu.edu.cn

  • Zhengzhou Third People's Hospital"

    Zhengzhou, Henan, 450052

    Kong, 800-555-5522, 13383849341@139.com

Other trials in China

About this study

Official title: Nanocrystalline Megestrol Combined with Immunochemotherapy As First-Line Treatment for Cachexia in Extensive-Stage Small Cell Lung Cancer: a Patient-Centered Phase II Study

This study hypothesizes that nanocrystalline megestrol acetate can improve the cachexia condition in patients and enhance the efficacy of immunochemotherapy regimens. It plans to enroll patients newly diagnosed with extensive-stage small-cell lung cancer (ES-SCLC) who are in the pre-cachexia or cachexia stage of the cachexia trajectory. These patients will receive first-line standard immunochemotherapy combined with nanocrystalline megestrol acetate intervention. Compared to the use of the first-line standard immunochemotherapy regimen alone, the study will monitor changes in body weight and body composition, which are nutritional status indicators relative to baseline, to assess whether these changes can translate into improved survival benefits and enhanced quality of life for patients.

The objective of this clinical study are：1.To assess the change in body weight relative to baseline in malignant patients with ES-SCLC treated with a first-line standard immunochemotherapy regimen during treatment with a simultaneous co-administration of nanocrystalline megestrol supportive intervention, compared to standard treatment. 2.To assess the impact of simultaneous co-administration of nanocrystalline megestrol supportive intervention during treatment with a first-line standard immunochemotherapy regimen, compared to standard treatment, on survival benefit and quality of life in patients with ES-SCLC malignancy. 3.To explore the improvement in inflammatory and nutritional markers and changes in lymphocyte subpopulations in patients with ES-SCLC malignant disease with simultaneous co-administration of nanocrystalline megestrol supportive intervention during treatment with a first-line standard immunochemotherapy regimen, compared to standard treatment.

Read the detailed description

This study employed a Phase II adaptive umbrella trial , aiming to enrich patients with ES - SCLC in the pre - cachexia or cachexia stage and provide them with the opportunity to receive potentially effective megestrol acetate treatment. To expand the scope of patients receiving treatment and enhance the understanding of the benefit - risk profile in a broader population, we established two cohorts: the criteria - fulfilled (CF) cohort, where patients need to meet all inclusion and exclusion criteria; and the compassionate use (CU) cohort, where patients meet the inclusion criteria and major exclusion criteria but may not meet the minor exclusion criteria. Concurrently, a prospective real - world study (RWS) was initiated to observe the clinical outcomes of patients in the pre - cachexia/cachexia stage receiving physician - selected treatment (PTOC).

The CF cohort plans to enroll 200 subjects, with liver metastasis (yes vs no), cachexia stage (pre - cachexia vs cachexia), and ECOG PS (0 - 1 vs 2) as stratification factors. These subjects will be randomly assigned to 2 treatment groups at a 1:1 ratio:

  1. Nano - Megestrol Group: Nanocrystalline megestrol (QD, up to 12 weeks) + tislelizumab (Q3W, 4 cycles) + chemotherapy (carboplatin + etoposide, Q3W, 4 cycles);
  2. Standard Control Group: Tislelizumab (Q3W, 4 cycles) + chemotherapy (carboplatin + etoposide, Q3W, 4 cycles).

In the CU cohort, the treatment plan and visits are consistent with the nanocrystalline megestrol group in the criteria - fulfilled (CF) cohort.In the RWS cohort, immunotherapy can use PD - 1/PD - L1 inhibitors other than tislelizumab, and other drugs are consistent with the nanocrystalline megestrol group in the criteria - fulfilled (CF) cohort.

CU and RWS groups do not set a specific number of subjects to be enrolled.

Being tested
Nanocrystalline Megestrol Acetate, Tislelizumab, PTOC
Keywords
ES-SCLC

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 + Tislelizumab+ Chemotherapy (Carboplatin + Etoposide)

  • TislelizumabDrug

    Tislelizumab combined with chemotherapy (Carboplatin + Etoposide)

  • PTOCDrug

    Nanocrystalline Megestrol Acetate+PD-(L)1 inhibitors+chemotherapy

Study groups in NCT06793228
Study groupRoleWhat they receive
criteria-fulfilled (CF) cohortExperimentalPatients must meet all inclusion and exclusion criteria. Erolled patients will be randomly assigned to receive Nanocrystalline Megestrol Acetate (5ml once a day, up to 12 weeks) +Tislelizumab (200mg on day 1, once every 3 weeks) combined with chemotherapy (Carboplatin, AUC=5 on day 1+ Etoposide, 100mg/m2 on day 1 to day 3, once every 3 weeks). Megestrol will be discontinued after the completion of 4 cycles. Tislelizumab 200 mg will be used as maintenance therapy, repeated every 3 weeks until disease progression or intolerable toxicity.
Receives: Drug: Tislelizumab
Criteria-fulfilled(CF) cohortActive comparatorPatients must meet all inclusion and exclusion criteria. Erolled patients will be randomly assigned to receive Tislelizumab (200mg on day 1, once every 3 weeks) combined with chemotherapy (Carboplatin, AUC=5 on day 1+ Etoposide, 100mg/m2 on day 1 to day 3, once every 3 weeks). After 4 cycles of treatment, Tislelizumab 200 mg will be used as maintenance therapy, repeated every 3 weeks until disease progression or intolerable toxicity.
Receives: Drug: Nanocrystalline Megestrol Acetate
compassionate use (CU) cohortOtherPatients meet the inclusion criteria and main exclusion criteria, but may not meet the secondary exclusion criteria. Erolled patients will receive Nanocrystalline Megestrol Acetate (5ml once a day, up to 12 weeks) +Tislelizumab (200mg on day 1, once every 3 weeks) combined with chemotherapy (Carboplatin, AUC=5 on day 1+ Etoposide, 100mg/m2 on day 1 to day 3, once every 3 weeks). Megestrol will be discontinued after the completion of 4 cycles. Tislelizumab 200 mg will be used as maintenance therapy, repeated every 3 weeks until disease progression or intolerable toxicity.
Receives: Drug: Nanocrystalline Megestrol Acetate
prospective real-world study (RWS) cohortOtherObserve the clinical outcomes of ES-SCLC patients with pre-cachexia/cachexia receiving physician-targeted treatment (PTOC). Patients diagnozed with ES-SCLC, complicated pre-cachexia/cachexia, and are scheduled to receive chemo-immunotherapy will be included in this cohort. Erolled patients will receive Nanocrystalline Megestrol Acetate (5ml once a day, up to 12 weeks) + PD-1/L1 inhibitors + chemotherapy (Carboplatin, AUC=5 on day 1+ Etoposide, 100mg/m2 on day 1 to day 3, once every 3 weeks). Megestrol will be discontinued after the completion of 4 cycles. PD-1/L1 inhibitors will be used as maintenance therapy, repeated every 3 weeks until disease progression or intolerable toxicity.
Receives: Drug: PTOC

What is being measured

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

  1. The proportion of weight increase relative to baseline > 5% (Week 12)

    The proportion of weight increase relative to baseline > 5% (Week 12)

    Measured: after 12 weeks of treatment

Secondary outcomes (3)

  1. Objective Response Rate

    Proportion of patients with reduction in stable in tumor burden of a predefined amount，Baseline until partial response (PR) or complete response (CR), whichever occurs first，assessed up to 12 months

    Measured: From date of randomization until the date of first documented date of death from any cause, assessed up to 60 months

  2. Progression Free Survival (PFS)

    Time from random to either radiological progression or death

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

  3. overall survival (OS )

    Time from the first treatment to death from any cause or the end of the study

    Measured: From date of randomization until the date of first documented date of death from any cause, assessed up to 60 months

Timeline

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

  1. First posted27 Jan 2025
  2. Study start15 Jan 2025 (estimated)
  3. Primary completion15 Jan 2027 (estimated)
  4. Study completion15 Dec 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06793228
Sponsor's protocol ID
2024-542
Status last verified
Jan 2025
First submitted
7 Jan 2025
Last updated
27 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nanocrystalline Megestrol Acetate, Tislelizumab and PTOC in people with SCLC, Extensive Stage, run by Henan Cancer Hospital at 4 sites 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 21 inclusion and 27 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 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 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 Qiming Wang (+86-0371-65588421, qimingwang1006@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 weight increase relative to baseline > 5% (Week 12) (time frame: after 12 weeks of treatment). 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 NCT06793228.

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 27 Jan 2025.

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