Megestrol Acetate for First-Line Treatment of Malnourished Non-Small Cell Lung Cancer

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHunan Province Tumor Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Nanocrystalline Megestrol Acetate Oral Suspension
  • PD-1/L1 inhibitor combined with chemotherapy

Treatment groups

116 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators