This study is a prospective, randomized, parallel-controlled clinical trial, primarily aimed at evaluating the level of body weight improvement of megestrol acetate combined with standard treatment compared with standard treatment in the first-line treatment of non-small cell lung cancer.
Voluntarily provide written informed consent (ICF).
Age ≥18 years at enrollment.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
Expected survival ≥6 months.
Diagnosis of NSCLC with EGFR sensitive mutation or ALK gene translocation; subjects with small cell carcinoma components in histology.
Presence of any condition affecting gastrointestinal absorption, such as difficulty swallowing, malabsorption, or uncontrollable vomiting; currently receiving tube feeding or parenteral nutrition; suffering from anorexia due to neurological or psychiatric disorders, or difficulty eating due to pain.
Currently taking or planning to take other medications that increase appetite or body weight, such as corticosteroids (excluding short-term dexamethasone during chemotherapy), androgens, progestins, thalidomide, olanzapine, anamorelin, or other appetite stimulants.
Patients with Cushing's syndrome, adrenal or pituitary insufficiency; patients with poorly controlled diabetes.
Parallel
Nanocrystalline Megestrol Acetate Oral Suspension
DrugNanocrystalline Megestrol Acetate Oral Suspension (125 mg/mL) was administered to the study group at 5 mL orally once daily (equivalent to 625 mg/day) until disease progression or completion of 12 weeks Other: PD-1/L1 inhibitor combined with chemotherapy
PD-1/L1 inhibitor combined with chemotherapy
Other interventionPD-1/L1 inhibitor combined with chemotherapy
change in body weight
To evaluate the change in body weight of megestrol acetate combined with standard treatment compared with standard treatment in the first-line treatment of NSCLC.
Objective Response Rate (ORR) and 1-year Progression-Free Survival (PFS) rate
To evaluate the Objective Response Rate (ORR) and 1-year Progression-Free Survival (PFS) rate (based on RECIST v1.1) of megestrol acetate combined with standard treatment compared with standard treatment in the first-line treatment of NSCLC.
change in appetite assessed by Anorexia/Cachexia Subscale 12 (A/CS-12)
To evaluate the change in appetite assessed by Anorexia/Cachexia Subscale 12 (A/CS-12) of megestrol acetate combined with standard treatment compared with standard treatment in the first-line treatment of NSCLC. An increase of ≥ 4 points in the A/CS-12 scale, or an A/CS-12 scale score of ≥ 37 points, indicates appetite improvement. If the above criteria are not met, it indicates no appetite improvement.
change in lean body mass
To evaluate the change in lean body mass of megestrol acetate combined with standard treatment
Number of completed treatment cycles and occurrence of treatment dose reduction
To evaluate the number of completed treatment cycles and the occurrence of treatment dose reduction of megestrol acetate plus standard therapy versus standard therapy alone as first-line treatment for non-small cell lung cancer (NSCLC).
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