Lung cancer
Conditions
Interventions
The test group:Osmertinib + wall removed Ganoderma lucidum spore powder
The control group:Osmertinib + placebo
Sponsors
Beijing Hospital of TCM, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Non-squamous and non-small cell lung cancer was diagnosed by cell/histopathology. (2) Imaging examinations including chest enhanced CT, head enhanced CT/MRI, neck/supraclavicular lymph node B-ultrasonography /CT, upper abdominal enhanced CT/ B-ultrasonography, and whole body bone scan were performed to determine the clinical stage as non-operable ?A-?. (3) Using the tissue specimens retained after pathological diagnosis, or when sufficient tissue specimens could not be obtained, peripheral blood free/tumor DNA (cf/ctDNA) was used for driver gene detection, and the results showed that: Sensitive mutations of epidermal growth factor receptor (EGFR) genes (19DEL, 21L858R). (4) Lung lesions can be measured. (5) ECOG-PS score =2 points, and expected survival > 3 months. (6) Age 18-75. (7) Agree to participate in this study and sign informed consent.
Exclusion criteria
Exclusion criteria: (1) Isolated brain/bone/adrenal metastases are present and radiation therapy is recommended. (2) Pregnant or lactating women, or those with serious heart, lung, liver, kidney, blood, and other systems, were assessed by the researchers as not suitable to participate in this study. (3) Known allergy to the study drug. (4) The subject is participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue scores in adverse EGFR-TKIs; | — |
Secondary
| Measure | Time frame |
|---|---|
| evaluation of therapeutic efficiency;Piper fatigue scale;QLQ-LC30;EQ-5D; | — |
Countries
China
Contacts
Public ContactGuowang Yang
Beijing Hospital of TCM, Capital Medical University
Outcome results
None listed