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

Phase II Clinical Study for Advanced Non-small Cell Lung Cancer Harboring HER2 Amplification or Mutations Treated with Pyrotinib and Apatinib

Excerpt:
...1) Aged 18 to 70 years; 2) Histologically or cytologically confirmed non-small cell lung cancer with stage IV disease; 3) HER2 exon 20 insertion mutations, primary HER2 missense mutations or primary HER2 amplification (HER2 copy number detected by NGS testing >= 3.62 or HER2 FISH+) confirmed by tumor tissue or plasma, pleural effusion, cerebrospinal fluid or other specimens; 4) Pretreated with first-line chemotherapy or ErbB-TKI targeted therapy and had experienced disease progression; 5) At least one radiographically measurable lesion exists; 6) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 7) Life expectancy of more than 12 week; 8) Left ventricular ejection fraction (LVEF) >= 50 percent (%) by echocardiogram (ECHO); 9) Adequate hepatic, renal, and hematologic functions are required including following parameters; a. ANC>= 1.5 x 10^9/L (1,500/mm3) b. Platelet count: >= 100 x 10^9/L (100,000/mm3) c. Hemoglobin >= 80 g/L (8 g/dL) d. SCr= 60 mL/min e. Total bilirubin = 2+, 24-hour urine protein quantitation shows that protein must be ...
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Efficacy and safety of pan-ErbB inhibitor pyrotinib combined with antiangiogenic agent apatinib for HER2-mutant or amplified metastatic NSCLC: A phase II clinical study.

Published date:
05/19/2021
Excerpt:
Metastatic NSCLC patients...harboring primary HER2 amplification, exon 20 insertion or activating missense mutations who had failed to prior chemotherapies or anti-HER2 TKIs were eligible to be enrolled...the overall ORR and DCR were 45.5% (15/33) and 93.9% (31/33), respectively. The median PFS was 6.8 (95%CI: 5.4-8.2) months. The median DoR and OS were 5.3 (95%CI: 0-11.8) and 12.9 (95%CI: 8.6-17.2) months, respectively....Pyrotinib combined with apatinib showed potent anti-tumor activity and acceptable safety profile in metastatic NSCLC with HER2 amplification or activating mutations.
DOI:
10.1200/JCO.2021.39.15_suppl.9035