EGFR positive advanced non-small cell lung cancer
Conditions
Interventions
Cohort A1 (SMET12+toripalimab+Pemetrexed Disodium +Carboplatin):None
Cohort A2 (SMET12+toripalimab +paclitaxel+cisplatin):None
Cohort B (SMET12+toripalimab+Docetaxel):None
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Has fully understood and voluntarily signed an informed consent form for this study , willing and able to comply with study procedures. 2. Age = 18 years. 3. Histologically confirmed EGFR positive (immunohistochemistry = [+]) advanced NSCLC ,including: (1) Cohort A: Treatment-naïve subjects; (2) Cohort B: Subjects resistant to first-line treatment contain immune checkpoint inhibitors (stability period > 3 months). 4. At least one measurable lesion via RECIST v1.1 criteria 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 6. Expected survival = 3 months. 7. Adequate organ function .
Exclusion criteria
Exclusion criteria: 1. Driver gene-positive (EGFR, ALK, ROS1) . 2. history of dual primary malignancies within the past 5 years. 3. active autoimmune diseases or a history of autoimmune disorders requiring systemic corticosteroid therapy. 4. systemic infections requiring systemic treatment. 5. known central nervous system metastases or other central nervous system diseases or abnormalities deemed unsuitable for inclusion in this study by the investigator. 6. Fertile individuals unable to maintain effective contraception during the trial. 7. Subjects in Cohort B who have received prior docetaxel treatment. 8. Subjects in Cohort B who experienced Grade 3 or higher immune-related adverse events during first-line treatment with immune checkpoint inhibitors. 9. Individuals deemed unsuitable for participation in this clinical trial by the investigator for various reasons .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of adverse events;rate of adverse events;Laboratory aberrations; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR(disease control rate);PFS(Progression Free Survival);ORR(objective response rate);DOR( Duration of Response); | — |
Countries
China
Contacts
Public ContactHe Zhiyong
Fujian Cancer Hospital
Outcome results
None listed