First-line pyrotinib in advanced HER2-mutant non-small-cell lung cancer: a patient-centric phase 2 trial

Author:

Liu Si-Yang Maggie,Tu Hai-Yan,Wei Xue-WuORCID,Yan Hong-Hong,Dong Xiao-Rong,Cui Jiu-Wei,Zhou Zhen,Xu Chong-RuiORCID,Zheng Ming-Ying,Li Yang-Si,Wang Zhen,Bai Xiao-Yan,Li An-Na,Sun Yue-Li,Huang Jie,Lin Jia-Xin,Ke E. E.,Xu Bing-Fei,Lu ChangORCID,Du Yingying,Chen Yuan,Ma Rui,Wang Bu-Hai,Cang Shun-Dong,Wang Bin-Chao,Chen Hua-Jun,Yang Jin-Ji,Li YangqiuORCID,Zhou QingORCID,Wu Yi-LongORCID

Funder

National Natural Science Foundation of China

Publisher

Springer Science and Business Media LLC

Subject

General Biochemistry, Genetics and Molecular Biology,General Medicine

Reference29 articles.

1. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biology Evaluation and Research. Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs. Guidance for Industry (2022); https://www.fda.gov/media/127712/download

2. Li, B. T. et al. Reimagining patient-centric cancer clinical trials: a multi-stakeholder international coalition. Nat. Med. 28, 620–626 (2022).

3. Liu, S. M. et al. Biomarker-driven studies with multi-targets and multi-drugs by next-generation sequencing for patients with non-small-cell lung cancer: an open-label, multi-center, phase II adaptive umbrella trial and a real-world observational study (CTONG1702&CTONG1705). Clin. Lung Cancer 23, e395–e399 (2022).

4. Real-world evidence. US Food and Drug Administration https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence (2022).

5. Stephens, P. et al. Lung cancer: intragenic ERBB2 kinase mutations in tumours. Nature 431, 525–526 (2004).

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