Non-small Cell Lung Cancer
Conditions
Brief summary
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.
Interventions
Nanocrystalline 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
Sponsors
Hunan Province Tumor Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * According to the 8th edition of the Lung Cancer TNM Staging Classification by the International Association for the Study of Lung Cancer (IASLC) and the American Joint Committee on Cancer (AJCC), subjects have histologically or cytologically confirmed locally advanced (Stage ⅢB/ⅢC) or metastatic (Stage IV) NSCLC that cannot be completely resected by surgery and cannot receive radical concurrent/sequential chemoradiotherapy. * Subjects have not received systemic chemotherapy for locally advanced or metastatic NSCLC before. For patients who have previously received adjuvant chemotherapy/radiotherapy, neoadjuvant chemotherapy/radiotherapy for non-metastatic diseases with curative intent, or radical chemoradiotherapy for locally advanced diseases, they are eligible to participate in this study if disease progression occurs more than 6 months after the end of the last treatment. * Subjects who have previously received PD-1/L1 inhibitors in the neoadjuvant phase are allowed to participate in this study after evaluation and approval by the investigator; subjects who have previously received PD-1/L1 inhibitors in the adjuvant phase or the consolidation treatment phase after radical chemoradiotherapy are not allowed to participate in this study. * No EGFR sensitive mutation or ALK gene translocation. For squamous NSCLC subjects with a smoking history or current smoking, if the previous EGFR and ALK status is unknown, it is considered negative. * Body mass index (BMI) ≤ 25. * At least one measurable tumor lesion according to RECIST v1.1.
Exclusion criteria
* 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. * Postmenopausal women with a history of abnormal vaginal bleeding within one year; premenopausal women with a history of abnormal endometrial thickening (\>15 mm) within one year. * Current radiological or clinical evidence of gastrointestinal obstruction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in body weight | a 12-week period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) and 1-year Progression-Free Survival (PFS) rate | 1-year period | 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) | a 12-week period | 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 | a 12-week period | 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 | a 12-week period | 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). |
Contacts
CONTACTyong chang Zhang
Outcome results
None listed