recurrent, metastatic, or advanced (IIIB-IV stage), driver gene negative, non-small cell lung cance
Conditions
Interventions
Experimental group:Ganoderma lucidum spore powder (wall removal) combined with ICIs+ standard chemotherapy regimen
Control group:5% ganoderma lucidum spore powder (wall removal) combined with ICIs+ standard chemotherapy regimen
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Cell/histopathological diagnosis of non-small cell lung cancer; 2. By chest CT, head CT/MRI, neck/supraclavicular lymph node B-ultrasound /CT, upper abdomen CT/ B-ultrasound, whole body bone scan and other imaging examinations, the clinical stage was determined to be ?B (N2-3) -IV. 3. The driver gene test was performed with peripheral blood free/tumor DNA (cf/ctDNA) when tissue specimens were retained after pathological diagnosis, or when sufficient tissue specimens could not be obtained, and the results showed that the driver gene was negative; 4. Tumor can be measured according to RECIST1.1; 5.The ECOG-PS score was 0-1, and the expected survival time was more than 3 months; 6. Age 18-75 years old; 7. The patient has recovered from the toxicity of prior treatment (such as surgery, radiation, or treatment for a condition other than NSCLC), and recovery is defined as grade 2 or below toxicity (except hair loss) according to NCI-CTCAE; 8. Hematological indicators and organ function are sufficient to tolerate chemotherapy (excluding the use of any blood components and cell growth factors within 14 days) :White blood cell count =3.0×109/L, neutrophil count =1.5×109/L, platelet count =100×109/L, hemoglobin =9g/dL (90g/L), total bilirubin = 1.5 times the upper limit of normal (to allow benign hereditary hyperbilirubinemia,For example, patients with Gilbert´s syndrome were enrolled), ALT/AST and ALP= 3 times the upper limit of normal (or = 5 times the upper limit of normal if liver metastasis was present), creatinine clearance =45mL/min (calculated according to the standard Cockcroft and Gault formulas); 9.If the clinical stage of the included subjects is stage ?B, the following conditions must be met: No surgery or refusal of surgery after discussion by a multidisciplinary team; 10. According to the State Administration of Traditional Chinese Medicine "Guiding Principles for Clinical Research of New Chinese Medicine" diagnosis of lung qi deficiency syndrome; 11. Women of reproductive age or sexually active male patients should take effective contraceptive measures before enrollment (after signing the ICF and within 3 months after the treatment period and the end of treatment); 12. agree to participate in the study and sign the informed consent.
Exclusion criteria
Exclusion criteria: ? There are isolated brain/bone/adrenal metastases, radiation therapy is proposed; ?Patients who have previously received systemic therapy for metastatic or advanced NSCLC, excluding neoadjuvant or adjuvant therapy related to the primary cancer diagnosis; ?Any known active autoimmune disease or history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism);Subjects with vitiligo or complete remission of asthma in childhood could be included as adults without any intervention;Patients with asthma requiring medical intervention with bronchodilators were not included); ?Those who require long-term steroid therapy or immunosuppressive therapy; ?HIV positive, hepatitis B and/or C infection, active syphilis; ?A history of or co-occurrence of other malignancies, other than completely cured non-melanoma skin cancer, cervical carcinoma in situ or other cured cancers (no evidence of recurrence for at least 5 years); ?Cardiovascular disease (unstable angina pectoris, uncontrolled hypertension, myocardial infarction or ventricular arrhythmia or stroke within 6 months before starting standard chemotherapy, uncontrolled congestive heart failure or arrhythmia);Active severe infection or other serious complications; ?Have had any experimental therapy, immunotherapy, or monoclonal antibody therapy within 4 weeks before starting standard chemotherapy; ? Pregnant or lactating women; ? Known allergy to the investigational drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of symptom grading scale of lung Qi deficiency syndrome;PD-L1 expression; | — |
Secondary
| Measure | Time frame |
|---|---|
| Life quality evaluation;ORR(Objective response rate);DOR(Duration of Response);PFS(Progress Free Survival);OS((Overall Survival);One-year survival rate;QLQ-LC43 scale;Piper Fatigue Survey Scale;Appetite symptoms questionnaire for cancer patients; | — |
Countries
China
Contacts
Public ContactYanni Lou
China-Japan Friendship Hospital
Outcome results
None listed