Clinical trial NCT06208033: SMET12 and Toripalimab Combined Chemotherapy in Patients With EGFR Positive Advanced Non-small Cell Lung Cancer (NSCLC)
Official title: 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) : First-line Treatment or Failed From First-line Immune Checkpoint Inhibitor Treatment.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: EGFR Positive Non-small Cell Lung Cancer
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2024-01-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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) : first-line treatment or failed from first-line immune checkpoint inhibitor treatment.The primary objective is to evaluate the anti-tumor activity and safety of SMET12 and Toripalimab combined chemotherapy in patients with EGFR positive advanced NSCLC.


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 .

Primary outcomes:
measure: incidence of adverse events
timeFrame: 1 year
measure: rate of adverse events
timeFrame: 1 year
measure: Laboratory aberrations
timeFrame: 1 year
Secondary outcomes:
measure: disease control rate
timeFrame: 1 year
measure: Progression-free survival
timeFrame: 1 year
measure: DOR（ Duration of Response）
timeFrame: 1 year
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
Study officials:
References: