Non-small cell lung cancer
Conditions
Interventions
Control Group:Oral administration of osimertinib 80 mg once daily (qd) plus routine care
if diarrhea occurs, administer standard Western medical treatment for EGFR-TKI-associated diarrhea.
Treatment group:Add Shenling Baizhu Powder granules to the control group
if diarrhea occurs, provide standard Western medical treatment for EGFR-TKI-associated diarrhea.
Sponsors
Shenshan Medical Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Untreated patients with IIIB-IV NSCLC, with at least one measurable lesion confirmed by pathology or cytology; 2. Patients carrying EGFR-sensitive mutations (EGFR 19del or 21L858R), with or without EGFR T790M mutations, proposed to receive first-line osimertinib treatment; 3. Patients with a TCM syndrome classification of pulmonary and spleen qi deficiency; 4. Patients with good bowel movements in the past 4 weeks and no history of chronic diarrhea; 5. Patients aged 18 to 80 years (inclusive); 6. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 2; 7. Patients with an expected survival of at least 3 months; 8. Patients who understand the study, are able to cooperate with doctors for diarrhea grading assessment, have good compliance, and are willing to sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Patients with primary malignant tumors in other systems or organs; 2) Confirmed concomitant diseases causing diarrhea (e.g., acute or chronic enteritis, inflammatory bowel disease, etc.), radiation enteritis, or long-term use of laxatives; 3) Subjects with allergies to the investigational drug; 4) Patients with severe, uncontrolled organic lesions or infections (e.g., decompensated heart, lung, or kidney failure) that preclude tolerance of targeted therapy; 5) Pregnant or breastfeeding women; 6) Subjects currently participating in or who have participated in another clinical trial within the past 4 weeks; 7) Significant neurological or psychiatric history, including dementia that may impair comprehension and informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of diarrhea; | — |
Secondary
| Measure | Time frame |
|---|---|
| Diarrhea severity;Targeted Therapy Plan Modification Rate;TCM Syndrome Score;Safety Assessment; | — |
Countries
China
Contacts
Public ContactXiao Haiwei
Shenshan Medical Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Outcome results
None listed