DZD9008 in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With EGFR Mutations: Cohort Study
This study is a single center cohort study to access the anti-tumor efficacy, safety and tolerability of DZD9008 in patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) sensitizing mutations and EGFR uncommon mutations who have progressed following standard TKI therapy, and in treatment naive patients with NSCLC harboring EGFR Exon20 insertion mutation and EGFR sensitizing mutations.
• To provide a signed and dated, written informed consent.
• Aged ≥ 18 years old
• Histologically or cytologically confirmed locally advanced or metastatic NSCLC with documented EGFR mutations from a local laboratory
• ECOG performance status 0-1.
• Predicted life expectancy ≥ 12 weeks
• Patient must have measurable disease according to RECIST 1.1.
• Patient who has progressed or intolerant to standard therapy (except treatment naïve patients in Cohort 4 and Cohort 7: with EGFR Exon20ins; and in Cohort 5 with EGFR sensitizing mutation).
• Patients with brain metastasis (BM) can be enrolled under the condition that BM is stable, neurologically asymptomatic and does not require corticosteroid treatment.
• Adequate organ system function.
‣ Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L
⁃ Platelets ≥ 100 x 10\^9/L
⁃ Hemoglobin ≥ 9 g/dL
⁃ Total bilirubin ≤ 1.5 x ULN if no liver metastases or ≤ 3 x ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases
⁃ Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN if no liver metastases or ≤ 5 x ULN with liver metastases
⁃ Creatinine ≤ 1.5 x ULN, concurrent with calculated or measured creatinine clearance ≥ 50 mL/min as calculated by the Cockcroft-Gault method or ≥ 50 mL/min in 24 hours
⁃ International normalized ratio (INR) ≤ 1.5 x ULN and activated partial thromboplastin time (APTT) ≤ 1.5 x ULN;
⁃ Serum amylase ≤ 1.5 x ULN and serum lipase ≤ 1.5 x ULN