Efficacy and safety of Fuzheng Kangai granule combined with immune checkpoint inhitbitor for advanced non-small cell lung cancer: a randomized, double-blind, placebo-controlled trial
- Conditions
- non-small cell lung cancer (NSCLC)
- Registration Number
- ITMCTR2023000032
- Lead Sponsor
- Guangdong Provincial Hospital of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
(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.
(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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method progression free survival;
- Secondary Outcome Measures
Name Time Method incidence of adverse events;1-year survival rate;quality of life;overall survival;objective response rate;disease control rate;