This prospective interventional clinical study evaluates the efficacy of nanocrystalline megestrol combined with standard care in improving appetite and weight compared to standard care alone in first-line treatment of NSCLC.
(1) Voluntarily sign a written ICF. (2) The age at the time of enrollment is ≥18 years old. (3) The physical fitness score of Eastern Tumor Cooperation Organization (ECOG) is 0-2.
(1) NSCLC diagnosed with EGFR sensitivity mutation or ALK gene translocation; Histologic presence of a small cell carcinoma component is not allowed to enroll.
Parallel
nanocrystalline megestrol oral suspension + PD-1/L1 inhibitor combined with chemotherapy
DrugOral suspension of nanocrystalline megestrol is taken orally once a day until disease progression or 12 weeks (maximum duration of 12 weeks) PD-1/L1 inhibitors combined with chemotherapy are given every 3 weeks for one dosing cycle.
PD-1/L1 inhibitor combined with chemotherapy
DrugPD-1/L1 inhibitors combined with chemotherapy are given every 3 weeks for one dosing cycle.
Appetite improvement level
Proportion of subjects with an improvement in appetite based on A/CS-12 during the treatment period; (An increase of ≥4 points or ≥37 points on the A/CS-12 scale is defined as an improvement in appetite)
Weight improvement level
Proportion of subjects with an increase from baseline in BMI during the treatment period.
progression-free survival (PFS)
defined as the duration from the start treatment to progression, or patient death
Objective Response Rate (ORR)
define as the proportion of subjects who have a complete response (CR) or a partial response (PR)
L3 SMI
Changes in L3 skeletal muscle index (L3 SMI).
Nutritional status improvement level
Assess the patient's nutritional improvement from treatment based on the Nutritional Risk Screening Score Short Form (NRS2002)
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
