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Not yet recruiting NCT06961201

Nano-crystalline Megestrol Acetate Combined With Standard Treatment Versus Standard Treatment for First-line Extensive-stage Small Cell Lung Cancer in the Cachexia Phase

Phase III Interventional Extensive-stage Small Cell Lung Cancer (ES-SCLC) The Pre-cachexia or Cachexia Patients Who Have Not Received Systemic Treatment and Are Not Eligible for Curative Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nano-crystalline Megestrol Acetate Oral Suspension, standard treatment.
Who it may be relevant to
Registry conditions: Extensive-stage Small Cell Lung Cancer (ES-SCLC), The Pre-cachexia or Cachexia Patients Who Have Not Received Systemic Treatment and Are Not Eligible for Curative Therapy. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Nano-crystalline Megestrol Acetate Oral Suspension
    Nano-crystalline Megestrol Acetate Oral Suspension, with a specification of 125 mg/mL, the study group takes 5 mL orally per day (625 mg/day), and continues medication.
  • Drug standard treatment
    standard treatment

Primary outcome measures

  • The proportion of subjects with improved appetite based on A/CS-12 assessment [Time frame: Week 3]
  • The proportion of subjects with a relative increase in BMI from baseline [Time frame: Week 12]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • West China School of Medicine/West China Hospital of Sichuan University — Chengdu

Identifiers

NCT: NCT06961201 · Megaxia ES-SCLC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗