EGFR Positive Non-small Cell Lung Cancer
Conditions
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.
Interventions
DRUGSMET12
1. platinum-containing two-drug chemotherapy：Carboplatin plus Pemetrexed Disodium, administrated for 2-4 cycles, three weeks for one cycyles;Carboplatin 500mg/m2 d1,Pemetrexed Disodium AUV＝5 d1,Q3W; 2. Toripalimab, IV, 3mg/kg，Q2W； 3. SMET12: IV，60μg，Q2W，injected the day after toripalimab ；
Sponsors
Fujian Cancer Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of adverse events | 1 year | Adverse events incidence refers to the frequency of adverse events |
| rate of adverse events | 1 year | All adverse events will also be rated based on the NCI CTCAE version 5.0. |
| Laboratory aberrations | 1 year | Laboratory outliers refer to measurement results that significantly deviate from the normal reference range in laboratory testing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| disease control rate | 1 year | Disease control rate: DCR |
| Progression-free survival | 1 year | Progression-free survival (PFS) as assessed by the investigators according to RECIST 1.1 criteria |
| DOR（ Duration of Response） | 1 year | Duration of response (DoR) is defined as the time from first confirmed response (complete response or partial response) to the date of the initial objectively documented tumor progression as determined per investigator assessment using RECIST 1.1 criteria or death due to any cause, whichever occurs first. |
Countries
China
Contacts
Primary ContactZhiyong He
Outcome results
None listed