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

NCT06961201 | Not Yet Recruiting Phase 3

• 1 other identifier: Megaxia ES-SCLC
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (2)

• The proportion of subjects with improved appetite based on A/CS-12 assessment

  Week 3

• The proportion of subjects with a relative increase in BMI from baseline

  Week 12

Study Arms (2)

Nano-crystalline Megestrol Acetate Oral Suspension + Standard Therapy

EXPERIMENTAL

Drug: Nano-crystalline Megestrol Acetate Oral Suspension; Drug: standard treatment

Standard Therapy

ACTIVE COMPARATOR

Drug: standard treatment

Interventions

Nano-crystalline Megestrol Acetate Oral Suspension DRUG

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.

Nano-crystalline Megestrol Acetate Oral Suspension + Standard Therapy

standard treatment DRUG

standard treatment

Nano-crystalline Megestrol Acetate Oral Suspension + Standard Therapy; Standard Therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead
• West China Hospital: collaborator

Study Sites (1)

West China School of Medicine/West China Hospital of Sichuan University

Chengdu, Sichuan, 610000, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Lu Li

CONTACT

18980601778; windflower1991@vip.163.com

Dan Pu

CONTACT

13348826654; danpu_87@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 7, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 7, 2025

Record last verified: 2025-01

Locations

CN (1)