Status:
NOT_YET_RECRUITING
Nano-crystalline Megestrol Acetate Combined With Standard Treatment Versus Standard Treatment for First-line Extensive-stage Small Cell Lung Cancer in the Cachexia Phase
Lead Sponsor:
Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborating Sponsors:
West China Hospital
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
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT06961201
Start Date
May 1 2025
End Date
June 30 2027
Last Update
May 7 2025
Active Locations (1)
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1
West China School of Medicine/West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610000