nano-crystalline megestrol acetate combined with standard treatment versus standard treatment for first-line extensive-stage small cell lung cancer in the cachexia phase

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

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.


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.