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

A Study of RC48-ADC in Subjects With Advanced Non-small Cell Lung Cancer

Excerpt:
...HER2 protein overexpression (IHC 2+ or 3 +) or HER2 gene mutation (defined as exon 20 mutation), the previous test results confirmed by the researchers, both research centers and major research centers can be acceptable....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A Study of RC48-ADC Combined With Pyrotinib For Treatment of Local Advanced or Metastasis NSCLC With HER2 Mutation

Excerpt:
...- Documented HER2 exon 20 insertion mutation....
Trial ID:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Title:

588P - First real-world study with HER2 ADC in treating HER2-altered non-small cell lung cancer

Published date:
11/27/2023
Excerpt:
A total of 22 patients with HER2 alterations were enrolled, including 15 with HER2 mutations, 5 with HER2 amplifications, and 2 with both. The overall objective response rate (ORR) was 45.5% (10/22), disease control rate (DCR) was 90.9% (20/22), and median progression-free survival (mPFS) stood at 7.5 months (95% CI 6.6-8.4 months). 95.5% of patients (21/22) underwent combination therapy, yielding an ORR of 47.6% (10/21)....The mPFS was notably prolonged in HER2-amplified patients and anti-HER2 naïve patients....For HER2-altered NSCLC patients, RC48 combined therapies are applicable treatment options, particularly with platinum agents.