Metastatic (Stage IV) Non-squamous Non-small Cell Lung Cancer (Nsq-NSCLC) With Driver Gene NegativityPhase 3NCT06961188
Clinical Study on Nanocrystalline Megestrol Acetate for Appetite Improvement and Weight Gain in Pre-Cachexia and Cachexia Stages Key Terminology Analysis
A Phase 3 study testing Nano-crystalline Megestrol Acetate Oral Suspension and Standard Therapy in people with Metastatic (Stage IV) Non-squamous Non-small Cell Lung Cancer (Nsq-NSCLC) With Driver Gene Negativity and Untreated With Systemic Therapy, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of nanocrystalline medroxyprogesterone acetate for improving appetite and weight gain patients with non-small cell lung cancer (NSCLC) and cachexia and pre-cachexia. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Metastatic (Stage IV) Non-squamous Non-small Cell Lung Cancer (Nsq-NSCLC) With Driver Gene Negativity, Untreated With Systemic Therapy
- What is being tested?
- Nano-crystalline Megestrol Acetate Oral Suspension and Standard Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 31 Dec 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years at the time of enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Life expectancy ≥6 months.
- Histologically or cytologically confirmed metastatic (stage IV) driver gene-negative non-squamous non-small cell lung cancer (NSCLC) that is unresectable and not amenable to curative therapy
- Subjects with no prior systemic chemotherapy for metastatic non-small cell lung cancer (NSCLC).
Who cannot join
- Presence of any gastrointestinal absorption-impairing conditions (e.g., dysphagia, malabsorption, prior gastrectomy, or uncontrolled vomiting); current use of tube feeding/parenteral nutrition; or existence of anorexia nervosa, psychiatric disorder-induced anorexia, or pain-related feeding intolerance.
- Driver gene-positive NSCLC or histologically/cytologically confirmed squamous cell-dominant NSCLC.
- Patients with Cushing's syndrome, adrenal/pituitary insufficiency; poorly controlled diabetes mellitus.
- Concurrent enrollment in another clinical trial, unless it is an observational/non-interventional study or the follow-up phase of an interventional trial.
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
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Xiaorong Dong, 13986252286, xhzzdxr@126.com
About this study
Official title: Clinical Study on Nanocrystalline Megestrol Acetate for Appetite Improvement and Weight Gain in First-Line Non-Squamous Non-Small Cell Lung Cancer Patients During Pre-Cachexia and Cachexia Stages.
The purpose of this study is to evaluate the efficacy and safety of nanocrystalline medroxyprogesterone acetate for improving appetite and weight gain patients with non-small cell lung cancer (NSCLC) and cachexia and pre-cachexia. The enrolled patients were those with advanced NSCLC who had not received therapy, negative for driver genes and ineligible for curative treatment, and were planned to receive PD-1 inhibitors in combination with platinum-based chemotherapy.
- Conditions
- Metastatic (Stage IV) Non-squamous Non-small Cell Lung Cancer (Nsq-NSCLC) With Driver Gene Negativity, Untreated With Systemic Therapy
- Being tested
- Nano-crystalline Megestrol Acetate Oral Suspension, Standard Therapy
- Medical subject headings
- Neoplasm Metastasis
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
Nanocrystalline Megestrol Acetate Oral Suspension + Standard Therapy 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 (maximum treatment duration: 12 weeks), whichever occurred first.
Standard TherapyOther
Standard Therapy
| Study group | Role | What they receive |
|---|---|---|
| Nanocrystalline Megestrol Acetate Oral Suspension | Experimental | Not described Receives: Drug: Nano-crystalline Megestrol Acetate Oral Suspension; Other: Standard Therapy |
| No-Treatment Control | Active comparator | Not described Receives: Other: Standard Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of appetite improvement assessed by A/CS-12 (Anorexia/Cachexia Subscale of Functional Assessment of Anorexia/Cachexia Therapy)
Measured: Week 3
Proportion of individuals with weight gain exceeding 5% relative to baseline
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic (Stage IV) Non-squamous Non-small Cell Lung Cancer (Nsq-NSCLC) With Driver Gene NegativityStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961188
- Sponsor's protocol ID
- Megaxia ES-NSCLC-01
- Status last verified
- Apr 2025
- First submitted
- 29 Apr 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Nanocrystalline Megestrol Acetate for Appetite Improvement and Weight Gain in First-Line Non-Squamous Non-Small Cell Lung Cancer Patients During Pre-Cachexia and Cachexia Stages.
- ClinicalTrials.gov ID
- NCT06961188
- Acronym / sponsor ID
- Megaxia ES-NSCLC-01
- Conditions
- Metastatic (Stage IV) Non-squamous Non-small Cell Lung Cancer (Nsq-NSCLC) With Driver Gene Negativity, Untreated With Systemic Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 May 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.
The purpose of this study is to evaluate the efficacy and safety of nanocrystalline medroxyprogesterone acetate for improving appetite and weight gain patients with non-small cell lung cancer (NSCLC) and cachexia and pre-cachexia. The enrolled patients were those with advanced NSCLC who had not received therapy, negative for driver genes and ineligible for curative treatment, and were planned to receive PD-1 inhibitors in combination with platinum-based chemotherapy.
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 Oral Suspension | Experimental | Drug: Nano-crystalline Megestrol Acetate Oral Suspension, Other: Standard Therapy |
| No-Treatment Control | Active comparator | Other: Standard Therapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years at the time of enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Life expectancy ≥6 months.
- Histologically or cytologically confirmed metastatic (stage IV) driver gene-negative non-squamous non-small cell lung cancer (NSCLC) that is unresectable and not amenable to curative therapy
- Subjects with no prior systemic chemotherapy for metastatic non-small cell lung cancer (NSCLC).
Key exclusion criteria (4 listed)
- Presence of any gastrointestinal absorption-impairing conditions (e.g., dysphagia, malabsorption, prior gastrectomy, or uncontrolled vomiting); current use of tube feeding/parenteral nutrition; or existence of anorexia nervosa, psychiatric disorder-induced anorexia, or pain-related feeding intolerance.
- Driver gene-positive NSCLC or histologically/cytologically confirmed squamous cell-dominant NSCLC.
- Patients with Cushing's syndrome, adrenal/pituitary insufficiency; poorly controlled diabetes mellitus.
- Concurrent enrollment in another clinical trial, unless it is an observational/non-interventional study or the follow-up phase of an interventional trial.
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 SuspensionNanocrystalline Megestrol Acetate Oral Suspension + Standard Therapy 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 (maximum treatment duration: 12 weeks), whichever occurred first. | Drug | Nanocrystalline Megestrol Acetate Oral Suspension |
| Standard TherapyStandard Therapy | Other | Nanocrystalline Megestrol Acetate Oral Suspension, No-Treatment Control |
Primary outcome
Proportion of appetite improvement assessed by A/CS-12 (Anorexia/Cachexia Subscale of Functional Assessment of Anorexia/Cachexia Therapy)
Time frame: Week 3
Proportion of individuals with weight gain exceeding 5% relative to baseline
Time frame: Week 12
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 7 May 2025.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nano-crystalline Megestrol Acetate Oral Suspension and Standard Therapy in people with Metastatic (Stage IV) Non-squamous Non-small Cell Lung Cancer (Nsq-NSCLC) With Driver Gene Negativity and Untreated With Systemic Therapy, run by Changchun GeneScience Pharmaceutical Co., Ltd. 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 5 inclusion and 4 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 7 May 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?
Contact Xiaorong Dong (13986252286, xhzzdxr@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of appetite improvement assessed by A/CS-12 (Anorexia/Cachexia Subscale of Functional Assessment of Anorexia/Cachexia Therapy) (time frame: Week 3). 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?
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 7 May 2025.