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Pyrotinib in HER2-Mutant Advanced Lung Adenocarcinoma After Platinum-Based Chemotherapy: A Multicenter, Open-Label,
Caicun Zhou1, Xingya Li2, Qiming Wang3
1Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.
Purpose:
Targeted therapies against non-small-cell lung cancer (NSCLC) harboring HER2 mutations remain an unmet need. In this study, we assessed the efficacy and safety of pyrotinib in patients with HER2-mutant advanced NSCLC in a prospective, multicenter, open-label, single-arm, phase II study.
Patients And Methods:
Patients with stage IIIB or IV HER2-mutant lung adenocarcinoma who were previously treated with platinum-based chemotherapy were enrolled to receive pyrotinib at a dose of 400 mg/d for 21-day cycles. The primary end point was objective response rate per independent review committee (IRC).
Results:
Between October 20, 2016, and December 10, 2018, 60 patients received pyrotinib monotherapy. At baseline, 58 (96.7%) were stage IV, and 25 (41.7%) received at least 2 lines of prior chemotherapy. As of data cutoff on June 20, 2019, IRC-assessed objective response rate was 30.0% (95% CI, 18.8% to 43.2%). All subgroups of patients with different HER2 mutation types showed a favorable objective response rate. The objective response rates were similar between patients with and without brain metastases (25.0% v 31.3%). The median duration of response was 6.9 months (95% CI, 4.9 to 11.1 months). The median progression-free survival was 6.9 months (95% CI, 5.5 to 8.3 months) per IRC. The median overall survival was 14.4 months (95% CI, 12.3 to 21.3 months). Treatment-related adverse events of grade 3 or 4 occurred in 28.3% of patients, with the most common being diarrhea (20.0%; all grade 3). No treatment-related deaths were reported.
Conclusion:
Pyrotinib showed promising antitumor activity and an acceptable safety profile in chemotherapy-treated patients with HER2-mutant NSCLC.
Insights
Pyrotinib demonstrates promising antitumor activity in patients with HER2-mutant non-small-cell lung cancer (NSCLC). This targeted therapy showed a 30.0% objective response rate and an acceptable safety profile in previously treated individuals.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Non-small-cell lung cancer (NSCLC) with HER2 mutations presents a significant unmet therapeutic need.
- Targeted therapies are crucial for improving outcomes in advanced NSCLC patients.
Purpose of the Study:
- To evaluate the efficacy and safety of pyrotinib monotherapy.
- To assess pyrotinib's effectiveness in patients with HER2-mutant advanced NSCLC previously treated with chemotherapy.
Main Methods:
- A prospective, multicenter, open-label, single-arm, phase II study.
- 60 patients with stage IIIB or IV HER2-mutant lung adenocarcinoma received pyrotinib 400 mg/d.
- Primary endpoint was objective response rate (ORR) assessed by an independent review committee (IRC).
Main Results:
- IRC-assessed ORR was 30.0% (95% CI, 18.8% to 43.2%).
- Median duration of response was 6.9 months; median progression-free survival was 6.9 months.
- Median overall survival was 14.4 months, with manageable adverse events (diarrhea most common).
Conclusions:
- Pyrotinib exhibits promising antitumor activity in chemotherapy-treated patients with HER2-mutant NSCLC.
- The drug demonstrates an acceptable safety profile, supporting its potential as a targeted therapy option.
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