Clinical trial · Interventional
Nano-crystalline Megestrol Acetate Combined With Standard Treatment Versus Standard Treatment for First-line Extensive-stage Small Cell Lung Cancer in the Cachexia Phase
A Prospective, Randomized, Parallel-controlled Clinical Study of Nano-crystalline Megestrol Acetate Combined With Standard Treatment Versus Standard Treatment for First-line Extensive-stage Small Cell Lung Cancer (ES-SCLC) in the Cachexia Phase
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a prospective, randomized, parallel-controlled clinical trial, aiming to evaluate the efficacy and safety of nano-crystalline megestrol acetate combined with standard treatment compared to standard treatment alone as first-line therapy for extensive-stage small cell lung cancer (ES-SCLC) in both the pre-cachexia and cachexia phases. Participants enrolled in the study are those with ES-SCLC in the pre-cachexia or cachexia phase who have not received systemic treatment and are not eligible for curative therapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extensive-stage Small Cell Lung Cancer (ES-SCLC) | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| The Pre-cachexia or Cachexia Patients Who Have Not Received Systemic Treatment and Are Not Eligible for Curative Therapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nano-crystalline Megestrol Acetate Oral Suspension | Drug | — | UNRESOLVED |
| standard treatment | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Nano-crystalline Megestrol Acetate Oral Suspension + Standard Therapy
- interventionNames
- Drug: Nano-crystalline Megestrol Acetate Oral Suspension
- Drug: standard treatment
- type
- ACTIVE_COMPARATOR
- label
- Standard Therapy
- interventionNames
- Drug: standard treatment
Primary outcomes (2)
- measure
- The proportion of subjects with improved appetite based on A/CS-12 assessment
- timeFrame
- Week 3
- measure
- The proportion of subjects with a relative increase in BMI from baseline
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. * Life expectancy of ≥6 months. * Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) (according to the Veterans Administration Lung Study Group (VALG) staging system). * Participants must not have previously received systemic chemotherapy for ES-SCLC. For participants who have previously received adjuvant/neoadjuvant chemotherapy for non-metastatic disease with curative intent or concurrent/sequential chemoradiotherapy for locally advanced disease, they are eligible for this study if disease progression occurs \>6 months after the completion of the last treatment. * Participants who have previously received PD-1/L1 inhibitors in the neoadjuvant setting are allowed to participate in this study after investigator assessment and agreement. Participants who have previously received PD-1/L1 inhibitors in the adjuvant setting or as consolidation therapy after curative chemoradiotherapy are not eligible for this study. * At least one measurable tumor lesion according to RECIST v1.1. * Meet the criteria for pre-cachexia or cachexia diagnosis (based on the Fearon diagnostic criteria). Exclusion Criteria: * Presence of conditions that may affect gastrointestinal absorption, such as dysphagia, malabsorption, history of gastrectomy, or uncontrollable vomiting; ongoing enteral feeding or parenteral nutrition; or anorexia due to neurological causes, psychiatric conditions, or pain that makes eating difficult. * Currently taking or planning to take other medications that increase appetite or weight, such as corticosteroids (excluding short-term use of dexamethasone during chemotherapy), androgens, progestogens, thalidomide, olanzapine, anamorelin, or other appetite stimulants. * Patients with Cushing's syndrome, adrenal or pituitary insufficiency; patients with poorly controlled diabetes mellitus. * Concurrent enrollment in another clinical trial, unless it is an observational, non-interventional trial or the follow-up period of an interventional study. * Presence of unresolved toxicities from prior anti-tumor treatments. Unresolved is defined as not having returned to Grade 0 or 1 according to NCI CTCAE Version 5.0 (except for alopecia) or not having returned to the levels specified in the enrollment/exclusion criteria.
References
Publications (0)
Data not yet available