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AzTrials

Non-small Cell Lung CancerPhase 3NCT07477808

Megestrol Acetate for First-Line Treatment of Malnourished Non-Small Cell Lung Cancer

A Phase 3 study testing Nanocrystalline Megestrol Acetate Oral Suspension and PD-1/L1 inhibitor combined with chemotherapy in people with Non-small Cell Lung Cancer, run by Hunan Province Tumor Hospital.

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 is a prospective, randomized, parallel-controlled clinical trial, primarily aimed at evaluating the level of body weight improvement of megestrol acetate combined with standard treatment compared with standard treatment in the first-line treatment of non-small cell lung cancer. 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 Acetate Oral Suspension and PD-1/L1 inhibitor combined with chemotherapy
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
1 Apr 2026to 1 Apr 2029
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

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

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

yong chang Zhang contact

13873123436

zhangyongchang@csu.edu.cn

About this study

Official title: A Prospective, Randomized, Parallel-Controlled Clinical Study of Megestrol Acetate Oral Suspension for First-Line Treatment of Malnourished Non-Small Cell Lung Cancer

This study is a prospective, randomized, parallel-controlled clinical trial, primarily aimed at evaluating the level of body weight improvement of megestrol acetate combined with standard treatment compared with standard treatment in the first-line treatment of non-small cell lung cancer.

Being tested
Nanocrystalline Megestrol Acetate Oral Suspension, 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 Acetate Oral SuspensionDrug

    Nanocrystalline Megestrol Acetate Oral Suspension (125 mg/mL) was administered to the study group at 5 mL orally once daily (equivalent to 625 mg/day) until disease progression or completion of 12 weeks Other: PD-1/L1 inhibitor combined with chemotherapy

  • PD-1/L1 inhibitor combined with chemotherapyOther

    PD-1/L1 inhibitor combined with chemotherapy

Study groups in NCT07477808
Study groupRoleWhat they receive
Nanocrystalline Megestrol Acetate + PD-1/L1 inhibitor + chemotherapyExperimentalNanocrystalline Megestrol Acetate Oral Suspension+ PD-1/L1 inhibitor combined with chemotherapy
Receives: Drug: Nanocrystalline Megestrol Acetate Oral Suspension
PD-1/L1 inhibitor + chemotherapyPlacebo comparatorPD-1/L1 inhibitor combined with chemotherapy
Receives: Other: 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. change in body weight

    To evaluate the change in body weight of megestrol acetate combined with standard treatment compared with standard treatment in the first-line treatment of NSCLC.

    Measured: a 12-week period

Secondary outcomes (4)

  1. Objective Response Rate (ORR) and 1-year Progression-Free Survival (PFS) rate

    To evaluate the Objective Response Rate (ORR) and 1-year Progression-Free Survival (PFS) rate (based on RECIST v1.1) of megestrol acetate combined with standard treatment compared with standard treatment in the first-line treatment of NSCLC.

    Measured: 1-year period

  2. change in appetite assessed by Anorexia/Cachexia Subscale 12 (A/CS-12)

    To evaluate the change in appetite assessed by Anorexia/Cachexia Subscale 12 (A/CS-12) of megestrol acetate combined with standard treatment compared with standard treatment in the first-line treatment of NSCLC. An increase of ≥ 4 points in the A/CS-12 scale, or an A/CS-12 scale score of ≥ 37 points, indicates appetite improvement. If the above criteria are not met, it indicates no appetite improvement.

    Measured: a 12-week period

  3. change in lean body mass

    To evaluate the change in lean body mass of megestrol acetate combined with standard treatment

    Measured: a 12-week period

  4. Number of completed treatment cycles and occurrence of treatment dose reduction

    To evaluate the number of completed treatment cycles and the occurrence of treatment dose reduction of megestrol acetate plus standard therapy versus standard therapy alone as first-line treatment for non-small cell lung cancer (NSCLC).

    Measured: a 12-week period

Timeline

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

  1. First posted17 Mar 2026
  2. Study start1 Apr 2026 (estimated)
  3. Primary completion1 Apr 2028 (estimated)
  4. Study completion1 Apr 2029 (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
116 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07477808
Sponsor's protocol ID
2026-HNCA-Nourish-NSCLC
Status last verified
Mar 2026
First submitted
12 Mar 2026
Last updated
23 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Rowland KM Jr, Loprinzi CL, Shaw EG, Maksymiuk AW, Kuross SA, Jung SH, Kugler JW, Tschetter LK, Ghosh C, Schaefer PL, Owen D, Washburn JH Jr, Webb TA, Mailliard JA, Jett JR. Randomized double-blind placebo-controlled trial of cisplatin and etoposide plus megestrol acetate/placebo in extensive-stage small-cell lung cancer: a North Central Cancer Treatment Group study. J Clin Oncol. 1996 Jan;14(1):135-41. doi: 10.1200/JCO.1996.14.1.135.

    PubMed 8558188

  • Deschamps B, Musaji N, Gillespie JA. Food effect on the bioavailability of two distinct formulations of megestrol acetate oral suspension. Int J Nanomedicine. 2009;4:185-92. doi: 10.2147/ijn.s6308. Epub 2009 Sep 10.

    PubMed 19774117

  • Li Y, Song CK, Kim MK, Lim H, Shen Q, Lee DH, Yang SG. Nanomemulsion of megestrol acetate for improved oral bioavailability and reduced food effect. Arch Pharm Res. 2015 Oct;38(10):1850-6. doi: 10.1007/s12272-015-0604-9. Epub 2015 Apr 18.

    PubMed 25893430

  • Treger S, Ackerman S, Kaplan V, Ghanem S, Nadir Y. Progestin type affects the increase of heparanase level and procoagulant activity mediated by the estrogen receptor. Hum Reprod. 2021 Jan 1;36(1):61-69. doi: 10.1093/humrep/deaa263.

    PubMed 33306105

  • Fedotcheva TA. Clinical Use of Progestins and Their Mechanisms of Action: Present and Future (Review). Sovrem Tekhnologii Med. 2021;13(1):93-106. doi: 10.17691/stm2021.13.1.11. Epub 2021 Feb 28.

    PubMed 34513071

  • Trestini I, Gkountakos A, Carbognin L, Avancini A, Lanza M, Molfino A, Friso S, Corbo V, Tortora G, Scarpa A, Milella M, Bria E, Pilotto S. Muscle derangement and alteration of the nutritional machinery in NSCLC. Crit Rev Oncol Hematol. 2019 Sep;141:43-53. doi: 10.1016/j.critrevonc.2019.06.007. Epub 2019 Jun 15.

    PubMed 31228648

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nanocrystalline Megestrol Acetate Oral Suspension and PD-1/L1 inhibitor combined with chemotherapy in people with Non-small Cell Lung Cancer, run by Hunan Province Tumor Hospital.

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 10 inclusion and 6 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 23 Mar 2026. 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 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?

Contact yong chang Zhang (13873123436, zhangyongchang@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in body weight (time frame: a 12-week period). 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 NCT07477808, which also lists 6 linked publications.

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 23 Mar 2026.

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