# Overall Survival with Osimertinib in Untreated, EGFR -Mutated Advanced NSCLC

Source: https://onco.cc/key-papers/paper-osimertinib-nsclc-n-engl-j-med-2020/  
OnCo record `paper-osimertinib-nsclc-n-engl-j-med-2020` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Phase 2 or 3 results paper on Osimertinib in Non-small-cell lung cancer, in New England Journal of Medicine (2020), one of the most cited Europe PMC records with Osimertinib in its title.

## Summary

Background: Osimertinib is a third-generation, irreversible tyrosine kinase inhibitor of the epidermal growth factor receptor (EGFR-TKI) that selectively inhibits both EGFR-TKI-sensitizing and EGFR T790M resistance mutations. A phase 3 trial compared first-line osimertinib with other EGFR-TKIs in patients with EGFR mutation-positive advanced non-small-cell lung cancer (NSCLC). The trial showed longer progression-free survival with osimertinib than with the comparator EGFR-TKIs (hazard ratio for disease progression or death, 0.46). Data from the final analysis of overall survival have not been reported.

Methods: In this trial, we randomly assigned 556 patients with previously untreated advanced NSCLC with an EGFR mutation (exon 19 deletion or L858R allele) in a 1:1 ratio to receive either osimertinib (80 mg once daily) or one of two other EGFR-TKIs (gefitinib at a dose of 250 mg once daily or erlotinib at a dose of 150 mg once daily, with patients receiving these drugs combined in a single comparator group). Overall survival was a secondary end point.

Results: The median overall survival was 38.6 months (95% confidence interval [CI], 34.5 to 41.8) in the osimertinib group and 31.8 months (95% CI, 26.6 to 36.0) in the comparator group (hazard ratio for death, 0.80; 95.05% CI, 0.64 to 1.00; P = 0.046). At 3 years, 79 of 279 patients (28%) in the osimertinib group and 26 of 277 (9%) in the comparator group were continuing to receive a trial regimen; the median exposure was 20.7 months and 11.5 months, respectively. Adverse events of grade 3 or higher were reported in 42% of the patients in the osimertinib group and in 47% of those in the comparator group.

Conclusions: Among patients with previously untreated advanced NSCLC with an EGFR mutation, those who received osimertinib had longer overall survival than those who received a comparator EGFR-TKI. The safety profile for osimertinib was similar to that of the comparator EGFR-TKIs, despite a longer duration of exposure in the osimertinib group. (Funded by AstraZeneca; FLAURA ClinicalTrials.gov number, NCT02296125.).

Indexed on Europe PMC as PubMed record 31751012 (DOI 10.1056/nejmoa1913662). Its title names Osimertinib and its text names Non-small-cell lung cancer; PubMed types it as a clinical trial report (Clinical Trial, Phase III, Comparative Study, Research Support, Non-U.S. Gov't, Multicenter Study, Randomized Controlled Trial). It was matched automatically to the idea "Treat brain metastases as a disease with its own trials programme" and no figure has been checked by an editor.

## Fields

- Kind: Key paper
- Last checked: 2026-09-22
- Tags: europepmc-ingest
- Journal: New England Journal of Medicine
- Year: 2020
- DOI: 10.1056/nejmoa1913662
- Authors: Ramalingam SS, Vansteenkiste J, Planchard D, et al.
- What it means: One of the most cited trial reports Europe PMC returns for Osimertinib in Non-small-cell lung cancer, so it is a natural first reading for anyone weighing the idea it is linked from. The record was linked automatically by title and abstract; read the abstract above and the paper itself before relying on any figure.
- Caveats: Matched by Osimertinib in the title and Non-small-cell lung cancer in the title or abstract of the Europe PMC record; the summary reproduces the record's abstract and no figure has been verified against the full paper.; Chosen as a phase 2 or 3 report by the record's publication type or its own wording, not by reading the paper.

## Sources

- N Engl J Med 2020: https://doi.org/10.1056/nejmoa1913662
- PubMed: https://pubmed.ncbi.nlm.nih.gov/31751012/
- Europe PMC: https://europepmc.org/article/MED/31751012
- ClinicalTrials.gov NCT02296125: https://clinicaltrials.gov/study/NCT02296125

## Connected records

- trials: [FLAURA](https://onco.cc/trials/flaura/)
- journals: [New England Journal of Medicine](https://onco.cc/journals/nejm/)
- ideas: [Add a drug when the blood test turns, without stopping the one that works](https://onco.cc/ideas/idea-bio1-molecular-progression-add-on/), [Autonomous closed-loop adaptive therapy driven by blood tests and evolutionary models](https://onco.cc/ideas/idea-moon-closed-loop-adaptive-therapy/), [Slow the tumour's mutation engine with APOBEC inhibitors during targeted therapy](https://onco.cc/ideas/idea-bio1-apobec-inhibitor-adjunct/), [Treat brain metastases as a disease with its own trials programme](https://onco.cc/ideas/idea-fund-brain-metastases-programme/)

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