Nano-crystalline Megestrol Acetate Combined With Standard Treatment Versus Standard Treatment for First-line Extensive-stage Small Cell Lung Cancer in the Cachexia Phase
Launched by CHANGCHUN GENESCIENCE PHARMACEUTICAL CO., LTD. · Apr 29, 2025
Trial Information
Current as of July 27, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating whether a new treatment called nano-crystalline megestrol acetate, when combined with standard therapy, is more effective than standard therapy alone for patients with extensive-stage small cell lung cancer (ES-SCLC) who are in the pre-cachexia or cachexia phases. Cachexia is a condition that causes weight loss and muscle wasting, which can happen in advanced cancer. The study aims to help those who have not received other treatments and are not eligible for curative therapies.
To participate, patients must be between the ages of 65 and 74, have a certain performance level (ECOG score of 0-2), and have a life expectancy of at least six months. They should have a confirmed diagnosis of ES-SCLC and at least one measurable tumor. However, individuals with certain medical conditions that can affect eating or absorption, or those currently on appetite-increasing medications, cannot join the study. Participants can expect to receive either the new treatment with standard care or just the standard care and will be monitored for safety and effectiveness throughout the trial. This study is currently not recruiting participants, but it aims to provide valuable insights into better treatment options for this challenging condition.
Gender
ALL
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.
About Changchun Genescience Pharmaceutical Co., Ltd.
Changchun Genescience Pharmaceutical Co., Ltd. is a pioneering biopharmaceutical company based in Changchun, China, dedicated to the research, development, and commercialization of innovative therapies. With a strong focus on genetic and cellular medicine, the company leverages cutting-edge technologies to address unmet medical needs across various therapeutic areas, including oncology, autoimmune diseases, and rare genetic disorders. Committed to enhancing patient outcomes, Changchun Genescience collaborates with leading research institutions and healthcare professionals to advance its clinical trials and bring safe, effective treatments to market.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chengdu, Sichuan, China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported