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Association details:
| Biomarker: | HER-2 mutation |
|---|---|
| Cancer: | Solid Tumor |
| Drug: | Irene (pyrotinib) (EGFR inhibitor, HER2 inhibitor, HER4 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
A Clinical Study of the Effcacy and Safety of Pyrotinib Combined with Chemotherapy in the First-Line Treatment of Patients with HER2-Mutant Advanced Non-Small Cell Lung Cancer
Excerpt:
...Definition of HER2-mutant NSCLC: insertion mutation and point mutation of HER2 gene were confirmed by gene detection of tumor tissue or blood, pleural effusion, cerebrospinal fluid and other samples; 6. ...
Trial ID:
Source:
Title:
PD-1 Combined With Pyrotinib for Chemotherapy Failure HER2 Insertion Mutation Advanced NSCLC
Excerpt:
...- HER2 insertion mutation-positive...
Trial ID:
More C2 evidence
Source:
Title:
Phase 3 Study of Pyrotinib Versus Docetaxel in Patients With Advanced Non-squamous NSCLC Harboring a HER2 Exon 20 Mutation Who Failed Platinum Based Chemotherapy
Excerpt:
...- Before enrollment, a documented confirmed presence of activating mutations in exon 20 of the HER2 gene must be provided....
Trial ID:
Source:
Title:
A Real-World Study of Pyrotinib Maleate in the Treatment of Advanced/Metastatic Non-Small Cell Lung Cancer With Rare Mutations in HER2
Excerpt:
...HER2 mutation and amplification confirmed by gene testing of tumor tissue or blood, pleural effusion, cerebrospinal fluid and other specimens;...
Trial ID:
Source:
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:
Source:
Title:
A Clinica Study of Pyrotinib in Patients of Advanced Non-Small Cell Lung Cancer With HER2 Mutation
Excerpt:
...Confirmed HER2 mutation by Central Laboratory。 7....
Trial ID:
Source:
Title:
A multicenter study for pyrotinib maleate in the treatment of advanced non-small cell lung adenocarcinoma with HER2 mutation
Excerpt:
...Confirmed HER2 mutation by Central Laboratoryincluded PCRFISH, NGS; 5. ...
Trial ID:
Source:
Title:
An exploratory basket study of non-breast cancer patients with HER2 mutation or amplification who failed in standard treatment with pyrotinib maleate tablets
Excerpt:
...Cancer tissue pathology is clearly HER2 positive: including IHC2+/ISH+, IHC 3+ or HER2 mutations (the results obtained by NGS method, PCR method, Sanger method, mass spectrometry sequencing and other measurement methods are all acceptable). ...
Trial ID:
Source:
Title:
A real-world study of pyrotinib maleate in the treatment of brain metastases from HER2-positive solid tumors
Excerpt:
...HER2-positive (gene mutation, gene amplification, protein overexpression) solid tumor confirmed by histology or cytology; 3. ...
Trial ID:
Source:
Title:
An Exploratory Basket Study of Pyrotinib Maleate Tablets in HER2 Mutated or Amplified of Metastatic Solid Tumors
Excerpt:
...HER2 mutated non-small cell lung cancer , gastric and gastroesophageal junction adenocarcinoma or Adenocarcinoma of the colon has been confirmed by Pathology....
Trial ID:
Source:
Title:
Phase I Study of Pyrotinib in Patients With HER2-positive Solid Tumors
Excerpt:
...- have confirmed HER2 gene amplified tumor fluorescence in-situ hybridization (FISH, HER2/cep17 ratio > 2) or HER2 overexpression (IHC 3+) or documented HER2 gene mutation....
Trial ID:
Less C2 evidence
Source:
Title:
Safety and efficacy of pyrotinib in patients with NSCLC and other advanced solid tumors with activating HER2 alterations: A phase I basket trial
Published date:
05/28/2020
Excerpt:
A total of 62 pts were enrolled...24 pts with HER2-mutant NSCLC (20, i.e. 65% of which were the A775_G776insYVMA mutation) and 18 pts with HER2-mutant or amplified solid tumors completed end of Cycle 2 imaging scan and were evaluable for tumor responses. The ORR was 19% (8/42, 95% CI 7-31%); confirmed responses include a complete response (CR)...and 4 PRs in HER2-amplified cholangiocarcinoma, ovarian, endometrial and salivary gland carcinomas....Pyrotinib demonstrated a manageable safety profile and encouraging efficacy in pts with heavily pre-treated HER2-mutant NSCLC.
DOI:
28.5.2020
Trial ID:
