Trial reportJapanese journal of clinical oncology2019
Osimertinib versus standard-of-care EGFR-TKI as first-line treatment for EGFRm advanced NSCLC: FLAURA Japanese subset.
Trial report in Japanese journal of clinical oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02296125 (A Phase III, Double-blind, Randomised Study to Assess the Safety and Efficacy of AZD9291 Versus a Standard of Care Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor as First Line Treatment in Patients With Epidermal Growth Factor Receptor Mutation Positive, Locally Advanced or Metastatic Non Small Cell Lung Cancer.), which is not on this map. Cited by 90 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase III, Double-blind, Randomised Study to Assess the Safety and Efficacy of AZD9291 Versus a Standard of Care Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor as First Line Treatment in Patients With Epidermal Growth Factor Receptor Mutation Positive, Locally Advanced or Metastatic Non Small Cell Lung Cancer.
Who cites it
90 citing papers in PubMed, 5 syntheses or guidelines pooled it, 148 citations in OpenAlex.
- Guideline
- Pooled it
- The Relationship Between Short-Term Surrogate Endpoint Indicators and mPFS and mOS in Clinical Trials of Malignant Tumors: A Case Study of Approved Molecular Targeted Drugs for Non-Small-Cell Lung Cancer in China.Frontiers in pharmacology · 2022Pooled it
- The efficacy and safety of osimertinib in treating nonsmall cell lung cancer: A PRISMA-compliant systematic review and meta-analysis.Medicine · 2020Pooled it
- Osimertinib or EGFR-TKIs/chemotherapy in patients with EGFR-mutated advanced nonsmall cell lung cancer: A meta-analysis.Medicine · 2019Pooled it
- Lazertinib versus Gefitinib as First-Line Treatment for EGFR-mutated Locally Advanced or Metastatic NSCLC: LASER301 Korean Subset.Cancer research and treatment · 2024Trial
- A Phase II Trial on Osimertinib as a First-Line Treatment for EGFR Mutation-Positive Advanced NSCLC in Elderly Patients: The SPIRAL-0 Study.The oncologist · 2022Trial
- Real-world use of osimertinib for epidermal growth factor receptor T790M-positive non-small cell lung cancer in Japan.Japanese journal of clinical oncology · 2020Trial
- Drug-specific timing and fatality patterns of EGFR-TKI-associated interstitial lung disease in NSCLC-related JADER reports.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- First-line third-generation EGFR-TKIs for advanced EGFR-mutated non-small cell lung cancer: a systematic review and network meta-analysis of randomized controlled trials.Journal of thoracic disease · 2026Article
- Osimertinib-induced interstitial lung disease insights from faers signal detection and network toxicology analysis.BMC cancer · 2026Article
- Osimertinib opens the door for patients withTranslational lung cancer research · 2026Article
- Osimertinib for Patients With EGFR-Mutated Non-Small Cell Lung Cancer: Current Evidence.Clinical Medicine Insights. Oncology · 2026Review
- Analysis of prognostic factors influencing brain metastasis in EGFR-mutant lung adenocarcinoma and comparison of prognostic assessment models.Oncology letters · 2026Article
- RELAY+: Final Overall Survival With Ramucirumab Plus Gefitinib in Patients With UntreatedJTO clinical and research reports · 2025Article
- Survival outcomes of upfront versus delayed craniocerebral radiotherapy in EGFR-mutant NSCLC patients treated with third-generation EGFR-TKIs.Clinical & experimental metastasis · 2025Article
- Successful Switch to Afatinib and Osimertinib Rechallenge with Corticosteroids after Osimertinib-induced Interstitial Lung Disease: A Case Report and Literature Review.Internal medicine (Tokyo, Japan) · 2025Review
- Resistance mutations and the blood-brain barrier: Key challenges in targeted treatment of brain metastatic non-small cell lung cancer.Acta pharmaceutica Sinica. B · 2025Review
- J-REGISTER: real-world study of Japanese patients withFuture oncology (London, England) · 2025Observational
- [Research Status and Progress of Third-generation EGFR-TKIs in Elderly Patients with Non-small Cell Lung Cancer].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2025Review
30 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 12 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe FLAURA study was a multicenter, double-blind, Phase 3 study in which patients with previously untreated epidermal growth factor receptor mutation-positive advanced non-small-cell lung carcinoma were randomized 1:1 to oral osimertinib 80 mg once daily or standard-of-care (gefitinib 250 mg or erlotinib 150 mg, once daily) to compare safety and efficacy. In the overall FLAURA study, significantly better progression-free survival was shown with osimertinib versus standard-of-care.
methodsSelected endpoints, including progression-free survival (primary endpoint), overall survival, objective response rate, duration of response and safety were evaluated for the Japanese subset of the FLAURA study.
resultsIn Japan, 120 eligible Japanese patients were randomized to osimertinib (65 patients) or gefitinib (55 patients) treatment from December 2014 to June 2017. Median progression-free survival was 19.1 (95% confidence interval, 12.6, 23.5) and 13.8 (95% confidence interval, 8.3, 16.6) months with osimertinib and gefitinib, respectively (hazard ratio, 0.61; 95% confidence interval, 0.38, 0.99). Median overall survival was not reached in either treatment arm (data were immature). In the osimertinib and gefitinib arms, objective response rate was 75.4% (49/65) and 76.4% (42/55), and median duration of response from onset was 18.4 (95% confidence interval, not calculated) and 9.5 (95% confidence interval, 6.2, 13.9) months, respectively. The incidence of adverse events was similar in the two groups. The frequency of Grade ≥3 interstitial lung disease and pneumonitis in the two groups were the same (one patient).
conclusionsAs the first-line therapy, osimertinib showed significantly improved efficacy versus gefitinib in the Japanese population of the FLAURA study. No new safety concerns were raised. CLINICAL
trial registrationNCT02296125 (ClinicalTrials.gov).
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.