NCT06793228

Nanocrystalline Megestrol + Immunochemo As 1st-Line for ES-SCLC Cachexia

Nanocrystalline Megestrol Combined with Immunochemotherapy As First-Line Treatment for Cachexia in Extensive-Stage Small Cell Lung Cancer: a Patient-Centered Phase II Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study hypothesizes that nanocrystalline megestrol acetate can improve the cachexia condition in patients and enhance the efficacy of immunochemotherapy regimens. It plans to enroll patients newly diagnosed with extensive-stage small-cell lung cancer (ES-SCLC) who are in the pre-cachexia or cachexia stage of the cachexia trajectory. These patients will receive first-line standard immunochemotherapy combined with nanocrystalline megestrol acetate intervention. Compared to the use of the first-line standard immunochemotherapy regimen alone, the study will monitor changes in body weight and body composition, which are nutritional status indicators relative to baseline, to assess whether these changes can translate into improved survival benefits and enhanced quality of life for patients. The objective of this clinical study are：1.To assess the change in body weight relative to baseline in malignant patients with ES-SCLC treated with a first-line standard immunochemotherapy regimen during treatment with a simultaneous co-administration of nanocrystalline megestrol supportive intervention, compared to standard treatment. 2.To assess the impact of simultaneous co-administration of nanocrystalline megestrol supportive intervention during treatment with a first-line standard immunochemotherapy regimen, compared to standard treatment, on survival benefit and quality of life in patients with ES-SCLC malignancy. 3.To explore the improvement in inflammatory and nutritional markers and changes in lymphocyte subpopulations in patients with ES-SCLC malignant disease with simultaneous co-administration of nanocrystalline megestrol supportive intervention during treatment with a first-line standard immunochemotherapy regimen, compared to standard treatment.

Detailed description

This study employed a Phase II adaptive umbrella trial , aiming to enrich patients with ES - SCLC in the pre - cachexia or cachexia stage and provide them with the opportunity to receive potentially effective megestrol acetate treatment. To expand the scope of patients receiving treatment and enhance the understanding of the benefit - risk profile in a broader population, we established two cohorts: the criteria - fulfilled (CF) cohort, where patients need to meet all inclusion and exclusion criteria; and the compassionate use (CU) cohort, where patients meet the inclusion criteria and major exclusion criteria but may not meet the minor exclusion criteria. Concurrently, a prospective real - world study (RWS) was initiated to observe the clinical outcomes of patients in the pre - cachexia/cachexia stage receiving physician - selected treatment (PTOC). The CF cohort plans to enroll 200 subjects, with liver metastasis (yes vs no), cachexia stage (pre - cachexia vs cachexia), and ECOG PS (0 - 1 vs 2) as stratification factors. These subjects will be randomly assigned to 2 treatment groups at a 1:1 ratio: 1. Nano - Megestrol Group: Nanocrystalline megestrol (QD, up to 12 weeks) + tislelizumab (Q3W, 4 cycles) + chemotherapy (carboplatin + etoposide, Q3W, 4 cycles); 2. Standard Control Group: Tislelizumab (Q3W, 4 cycles) + chemotherapy (carboplatin + etoposide, Q3W, 4 cycles). In the CU cohort, the treatment plan and visits are consistent with the nanocrystalline megestrol group in the criteria - fulfilled (CF) cohort.In the RWS cohort, immunotherapy can use PD - 1/PD - L1 inhibitors other than tislelizumab, and other drugs are consistent with the nanocrystalline megestrol group in the criteria - fulfilled (CF) cohort. CU and RWS groups do not set a specific number of subjects to be enrolled.

Conditions

• SCLC, Extensive Stage

Interventions

Type	Name	Description
DRUG	Nanocrystalline Megestrol Acetate	Nanocrystalline Megestrol Acetate + Tislelizumab+ Chemotherapy (Carboplatin + Etoposide)
DRUG	Tislelizumab	Tislelizumab combined with chemotherapy (Carboplatin + Etoposide)
DRUG	PTOC	Nanocrystalline Megestrol Acetate+PD-(L)1 inhibitors+chemotherapy

Timeline

• Start date: 2025-01-15
• Primary completion: 2027-01-15
• Completion: 2027-12-15
• First posted: 2025-01-27
• Last updated: 2025-01-27

Locations

4 sites across 1 country: China