SMET12 and Toripalimab Combined Chemotherapy in Patients With EGFR Positive Advanced Non-small Cell Lung Cancer (NSCLC)

Launched by FUJIAN CANCER HOSPITAL · Jan 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with advanced non-small cell lung cancer (NSCLC) who have a specific genetic marker called EGFR. The trial looks at how well two drugs, SMET12 and Toripalimab, work together when given as a first treatment or after other treatments have not worked. The main goal is to see if this combination can help reduce the size of tumors and to check for any side effects.

To be eligible for this trial, participants need to be at least 18 years old and have a confirmed diagnosis of EGFR positive advanced NSCLC. They should have at least one measurable tumor and be in relatively good health, with an expected survival of at least three months. The trial is not yet recruiting participants, but it will include both men and women. If you or a loved one is considering joining this study, you can expect to receive the new treatment while being closely monitored by healthcare professionals for any effects or changes in your condition.

Gender

ALL

Eligibility 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:
• • 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 .