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Osimertinib Versus Comparator EGFR TKI as First-Line Treatment for EGFR-Mutated Advanced NSCLC: FLAURA China, A
Ying Cheng1, Yong He2, Wei Li3
1Department of Medical Oncology, Jilin Provincial Cancer Hospital, Changchun, 130000, China. jl.cheng@163.com.
Background:
In the global FLAURA study, first-line osimertinib, a third-generation irreversible tyrosine kinase inhibitor (TKI) of epidermal growth factor receptor (EGFR), significantly improved progression-free survival (PFS) and overall survival (OS) versus comparator EGFR TKIs in patients with EGFR mutation-positive (EGFRm) advanced non-small-cell lung cancer (NSCLC).
Objective:
The FLAURA China study assessed first-line osimertinib in Chinese patients with EGFRm advanced NSCLC (NCT02296125).
Methods:
FLAURA China was a double-blind, randomized, phase III study. Adults from mainland China with previously untreated EGFRm (Exon 19 deletion or L858R) advanced NSCLC were enrolled in the global study or a China-only study under the same protocol; 136 patients were randomized to osimertinib (80 mg once daily [od]; n = 71) or comparator EGFR TKI (gefitinib or erlotinib; all sites selected gefitinib 250 mg od; n = 65). Patients were randomized and allocated to treatment groups by a central computer system. Treatment continued until disease progression, unacceptable toxicity, or withdrawal of consent. The primary endpoint was investigator-assessed PFS; OS was a secondary endpoint.
Results:
All 136 randomized patients were analyzed. Osimertinib extended median PFS by 8.0 months versus comparator EGFR TKI (17.8 vs. 9.8 months; hazard ratio [HR] 0.56; 95% confidence interval [CI] 0.37-0.85). Median OS was 33.1 months in the osimertinib group versus 25.7 months in the comparator group (HR 0.85; 95% CI 0.56-1.29). At 3 years, 20% of patients on osimertinib and 8% on the comparator remained on randomized treatment. Grade 3 or higher adverse events (AEs) were reported in 54 and 28% of patients in the osimertinib and comparator groups, respectively, driven by increased local reporting of laboratory- and disease-related AEs. No new safety signals were identified.
Conclusions:
First-line osimertinib treatment resulted in a clinically meaningful PFS and OS benefit versus comparator EGFR TKI in Chinese patients with EGFRm advanced NSCLC. Safety data were consistent with the known safety profile of osimertinib.
Clinical Trial Registration:
ClinicalTrials.gov NCT02296125, registered 20 November 2014.
Insights
First-line osimertinib significantly improved progression-free survival and overall survival in Chinese patients with EGFR mutation-positive advanced non-small-cell lung cancer compared to other EGFR TKIs. Safety was consistent with known profiles.
Area of Science:
- Oncology
- Pharmacology
Background:
- Epidermal growth factor receptor (EGFR) mutations drive advanced non-small-cell lung cancer (NSCLC).
- Third-generation EGFR tyrosine kinase inhibitors (TKIs) offer targeted therapy for EGFR mutation-positive (EGFRm) NSCLC.
Purpose of the Study:
- To evaluate the efficacy and safety of first-line osimertinib in Chinese patients with EGFRm advanced NSCLC.
- To compare osimertinib with standard EGFR TKIs (gefitinib or erlotinib) in this population.
Main Methods:
- A double-blind, randomized, phase III FLAURA China study.
- 136 adult patients with previously untreated EGFRm advanced NSCLC were randomized to osimertinib or comparator EGFR TKI.
- Primary endpoint: investigator-assessed progression-free survival (PFS); Secondary endpoint: overall survival (OS).
Main Results:
- Osimertinib significantly extended median PFS by 8.0 months (17.8 vs. 9.8 months) versus comparator.
- Median OS was 33.1 months with osimertinib versus 25.7 months with comparator.
- Grade 3+ adverse events were higher with osimertinib (54% vs. 28%), consistent with known safety profile; no new signals identified.
Conclusions:
- First-line osimertinib provides a clinically meaningful PFS and OS benefit in Chinese patients with EGFRm advanced NSCLC.
- The safety profile of osimertinib in this study is consistent with previous findings.
- Osimertinib represents an effective first-line treatment option for this patient group.
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