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

Pyrotinib Plus Thalidomide in Advanced NSCLC Patients Harboring HER2 Exon 20 Insertions

Excerpt:
...- HER2 exon 20 insertions confirmed by next generation sequencing or polymerase chain reaction (if blood samples are used, the mutation abundance should be ≥10%)....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Phase 2 Study of Pyrotinib in Previously Treated Patients With NSCLC Having EGFR or ERBB2 Exon 20 Insertion Mutation

Excerpt:
...Histologically or cytologic confirmed EGFR or HER2 Exon 20 Insertion Mutation positive advanced Non-small cell lung cancer who failed prior therapies....
Trial ID:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Efficacy and safety of pyrotinib in advanced lung adenocarcinoma with HER2 mutations: a multicenter, single-arm, phase II trial

Published date:
02/01/2022
Excerpt:
In this multicenter, single-arm, phase II trial, stage IIIB-IV NSCLC patients harboring HER2 mutations, as determined using next-generation sequencing, were enrolled and treated with pyrotinib at a dose of 400 mg/day....The 12-month PFS and OS rates were 28.4% and 38.6%, respectively. The mPFS and mOS were 5.6 months (95% CI, 2.8–8.4 months) and 10.5 months (95% CI, 8.7–12.3 months), respectively. Overall, 15 patients had a PR, for an ORR of 19.2% (15/78; 95% CI, 11.2–30.0%), including 11 patients with HER2 mutations in exon 20, three in exon 19, and one in exon 17 (Table 2, Fig. 3).
DOI:
https://doi.org/10.1186/s12916-022-02245-z