Abstract | BACKGROUND: METHODS: This is an open-label, single-arm phase II trial. A total of 39 advanced NSCLC patients with HER2 exon 20 insertions and ≤ 2 lines of prior chemotherapy will be recruited, including treatment-naïve patients who refuse chemotherapy. Patients are allowed to have prior therapy with immune checkpoint inhibitors and/or antiangiogenic agents. Those who have prior HER2-targeting therapy or other gene alterations with available targeted drugs are excluded. Eligible patients will receive oral pyrotinib 400 mg once daily and oral thalidomide 200 mg once daily until disease progression or intolerable toxicity. The primary endpoint is objective response rate. DISCUSSION: The addition of thalidomide to pyrotinib is expected to increase the clinical benefit in advanced NSCLC patients with HER2 exon 20 insertions, and reduce the incidence of pyrotinib-related diarrhea. We believe thalidomide is the stone that can hit two birds. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04382300 . Registered on May 11, 2020.
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Authors | Xinghao Ai, Zhengbo Song, Hong Jian, Zhen Zhou, Zhiwei Chen, Yongfeng Yu, Ziming Li, Shun Lu |
Journal | BMC cancer
(BMC Cancer)
Vol. 21
Issue 1
Pg. 1033
(Sep 16 2021)
ISSN: 1471-2407 [Electronic] England |
PMID | 34530760
(Publication Type: Clinical Trial Protocol, Journal Article)
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Copyright | © 2021. The Author(s). |
Chemical References |
- Acrylamides
- Aminoquinolines
- Angiogenesis Inhibitors
- ERBB2 protein, human
- Ikaros Transcription Factor
- IKZF1 protein, human
- IKZF3 protein, human
- Protein Kinase Inhibitors
- pyrotinib
- Receptor, ErbB-2
- Thalidomide
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Topics |
- Humans
- Acrylamides
(administration & dosage, adverse effects)
- Aminoquinolines
(administration & dosage, adverse effects)
- Angiogenesis Inhibitors
(administration & dosage, adverse effects)
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects, therapeutic use)
- Carcinoma, Non-Small-Cell Lung
(drug therapy, genetics, pathology)
- China
- Diarrhea
(chemically induced)
- Drug Administration Schedule
- Exons
- Ikaros Transcription Factor
(drug effects)
- Lung Neoplasms
(drug therapy, genetics, pathology)
- Mutation
- Protein Kinase Inhibitors
(administration & dosage, adverse effects)
- Receptor, ErbB-2
(antagonists & inhibitors, genetics)
- Thalidomide
(administration & dosage)
- Clinical Trials, Phase II as Topic
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