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Association details:
Evidence:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Exploratory clinical study for SZMD4-mal capsule in the treatment of locally advanced or metastatic NSCLC (non-resistant rare EGFR mutations only, including L861Q, G719X, and/or S768I)

Excerpt:
...(1) Aged 18 to 75 years; (2) Patients with locally advanced or metastatic NSCLC confirmed by histopathology and / or cytology; (3) The patient's EGFR has one or more of L861Q, G719X, and S768I mutations, and does not have T790M mutation, exon 19 deletion mutation, exon 20 insertion mutation, and L858R mutation; (4) ECOG physical strength score is 0, 1, or 2 points; (5) The expected survival time is> 3 months; (6) According to RECIST version 1.1, there is at least one evaluable tumor lesion; (7) Have sufficient blood system function, liver function, kidney function and coagulation function: Absolute neutrophil count >=1.5x10^9/L, platelet count >=90x10^9/L, hemoglobin >=90g/L; Total bilirubin <=1.5 ULN, alanine aminotransferase (ALT) <=2.5 ULN, aspartate aminotransferase (AST) <=2.5 ULN (total bilirubin in patients with liver metastases <=3.0 ULN, ALT<=5.0 ULN, AST<=5.0 ULN); Creatinine <=1.0 ULN, or creatinine clearance >=60mL/min (using Cockcroft-Gault method); International standardized ratio (INR) <=1.5; (8) Fertile qualified patients (male and female) must agree to use a reliable contraceptive method (hormonal or barrier method or abstinence) during the trial and at least 90 days after the last dose; female patients of childbearing age within 7 days before enrollment Blood human chorionic gonadotropin (HCG) pregnancy test must be negative; male patients cannot be sperm donated within 90 days after the first dose to the last dose; (9) All patients must be informed of the study before commencing any of the tests prescribed in this trial and voluntarily sign a written informed consent (ICF) approved by the ethics committee....
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

A phase 2a study evaluating the efficacy and safety of sutetinib in patients with advanced non–small-cell lung cancer (NSCLC) harboring uncommon EGFR mutations.

Published date:
05/25/2023
Excerpt:
In this multicenter, open-label phase 2a study, treatment-naïve adults with NSCLC harboring uncommon EGFR mutations (G719X, S768I, L861Q) received oral sutetinib monotherapy at 80 or 64 mg/day (Chinese trial register CTR20190681)….The disease control rate (DCR) was 96.4%, including 100.0% (14/14) and 92.8% (13/14) in the 80 and 64 mg/day cohorts, respectively....The median DoR was 12.5 months (20.3 and 9.2 months in the 80 and 64 mg/day cohorts, respectively). One-year OS was 84.7% (92.9% and 75.0% in the 80 and 64 mg/day cohorts, respectively).
DOI:
10.1200/JCO.2023.41.16_suppl.9131