Status:
NOT_YET_RECRUITING
SMET12 and Toripalimab Combined Chemotherapy in Patients With EGFR Positive Advanced Non-small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Fujian Cancer Hospital
Conditions:
EGFR Positive Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
This is a single-arm, sequential study assessing the efficacy and safety of SMET12 and Toripalimab combined chemotherapy in patients with EGFR positive advanced non-small cell lung cancer (NSCLC) : fi...
Eligibility Criteria
Inclusion
- 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
- 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 .
Key Trial Info
Start Date :
January 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06208033
Start Date
January 10 2024
End Date
December 30 2024
Last Update
January 17 2024
Active Locations (1)
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1
Fujian Cancer Hospital
Fuzhou, China