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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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 ;
1. platinum-containing two-drug chemotherapy:Carboplatin plus Pemetrexed Disodium, administrated for 2-4 cycles, 3 weeks for one cycle.cisplatin 75mg/m2 d1 Q3W,paclitaxel 100mg/m2 d1,d8,d15; 2. Toripalimab, IV, 3mg/kg,Q2W; 3. SMET12: IV,60μg,Q2W,injected the day after toripalimab ;
1. chemotherapy:Docetaxel 60-75 mg/m2 d1, administrated for 2-4 cycles, 3 weeks for one cycle. 2. Toripalimab, IV, 3mg/kg,Q2W; 3. SMET12: IV,60μg,Q2W,injected the day after toripalimab ;
Fujian Cancer Hospital
Fuzhou, China
incidence of adverse events
Adverse events incidence refers to the frequency of adverse events
Time frame: 1 year
rate of adverse events
All adverse events will also be rated based on the NCI CTCAE version 5.0.
Time frame: 1 year
Laboratory aberrations
Laboratory outliers refer to measurement results that significantly deviate from the normal reference range in laboratory testing.
Time frame: 1 year
disease control rate
Disease control rate: DCR
Time frame: 1 year
Progression-free survival
Progression-free survival (PFS) as assessed by the investigators according to RECIST 1.1 criteria
Time frame: 1 year
DOR( Duration of Response)
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.
Time frame: 1 year
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