non-small cell lung cancer (NSCLC)
Conditions
Interventions
Experimental group:PD-1 inhibitor ± chemotherapy + Fuzheng Kangai granule
Control group:PD-1 inhibitor ± chemotherapy + placebo granule
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (a) Patients who were confirmed advanced primary NSCLC (stage IIIb, IIIc, IVa, or IVb) by histology or cytology according to the 8th TNM classification of lung cancer without gene mutation and with positive PD-L1 expression; (b) Age from 18 to 80 years; (d) Life expectancy over 3 months; (e) Existing at least one measurable lesion; (f) Eastern Cooperative Oncology Group (ECOG) performance status less than 2 scores; (g) Meeting the indication of using PD-1 inhibitor; (h) Signing informed consent and participating in the study voluntarily.
Exclusion criteria
Exclusion criteria: (a) Participating in another interventional clinical study currently or within 4 weeks; (b) Prior immunotherapy; (c) Performing a major surgery within 3 weeks; (d) Using a long-term systemic corticosteroid; (e) Severe infection using antibiotics; (f) Dysphagia; (g) An active autoimmune disease requiring systemic treatment occurred within 2 years; (h) Currently pregnant or breastfeeding; (i) Symptomatic central nervous system metastases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| incidence of adverse events;1-year survival rate;quality of life;overall survival;objective response rate;disease control rate; | — |
Countries
China
Contacts
Public ContactXiaobing Yang
Guangdong provincial hospital of Chinese medicine
Outcome results
None listed