# LUX-Lung 3

Source: https://onco.cc/trials/lux-lung-3/  
OnCo record `lux-lung-3` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Showed that the second-generation EGFR pill afatinib beats chemotherapy for lung cancers driven by an EGFR mutation, and that the benefit is largest for the two common mutations.

## Summary

LUX-Lung 3 screened 1,269 patients and randomised 345 with EGFR-mutant stage IIIB or IV lung adenocarcinoma 2:1 to afatinib 40 mg daily or to cisplatin with pemetrexed for up to six cycles, stratified by mutation type (exon 19 deletion, L858R, or other) and race.

Median progression-free survival by independent review was 11.1 months with afatinib against 6.9 months with chemotherapy (hazard ratio 0.58, 95 percent confidence interval 0.43 to 0.78, p=0.001). Among the 308 patients with an exon 19 deletion or L858R, it was 13.6 against 6.9 months (hazard ratio 0.47, 0.34 to 0.65, p=0.001). Diarrhoea, rash or acne and stomatitis were the characteristic afatinib toxicities; patient-reported cough, breathlessness and pain were better controlled with afatinib.

Afatinib is a covalent pan-ErbB inhibitor, and the later pooled analysis of LUX-Lung 2, 3 and 6 is the main evidence for treating the uncommon EGFR mutations G719X, L861Q and S768I, for which it holds a distinct FDA indication, granted in 2018, that osimertinib does not.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-25
- Registry id: NCT00949650
- Phase: 3
- Setting: Untreated stage IIIB or IV lung adenocarcinoma with an EGFR mutation: afatinib 40 mg daily versus up to six cycles of cisplatin with pemetrexed, with progression-free survival by independent review as the primary endpoint
- Sponsor: Boehringer Ingelheim
- Enrolled: 345
- Result: Median progression-free survival 11.1 against 6.9 months (hazard ratio 0.58); 13.6 against 6.9 months in exon 19 deletion or L858R disease.
- Outcomes: Progression-free survival (independent review): Afatinib 11.1 months vs Cisplatin and pemetrexed 6.9 months, HR 0.58; Progression-free survival, exon 19 deletion or L858R: Afatinib 13.6 months vs Cisplatin and pemetrexed 6.9 months, HR 0.47
- Replication: LUX-Lung 6 reproduced the result in an Asian population with gemcitabine and cisplatin as the comparator; FLAURA later made osimertinib the first-line standard for the common mutations.

## Sources

- ClinicalTrials.gov NCT00949650: https://clinicaltrials.gov/study/NCT00949650
- LUX-Lung 3 (Journal of Clinical Oncology 2013): https://doi.org/10.1200/JCO.2012.44.2806

## Connected records

- cancers: [Adenocarcinoma of the lung](https://onco.cc/cancers/lung-adenocarcinoma/), [EGFR-mutated non-small-cell lung cancer](https://onco.cc/cancers/egfr-mutant-nsclc/), [Lung cancer (all types)](https://onco.cc/cancers/lung-cancer/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [Platinum agents](https://onco.cc/technologies/platinum/), [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [EGFR](https://onco.cc/targets/egfr/)
- drugs: [Afatinib](https://onco.cc/drugs/afatinib/), [Cisplatin](https://onco.cc/drugs/cisplatin/), [Pemetrexed](https://onco.cc/drugs/pemetrexed/)
- companies: [Boehringer Ingelheim](https://onco.cc/companies/boehringer-ingelheim/)
- terms: [EGFR exon 19 deletion & L858R](https://onco.cc/terms/egfr-exon19-l858r/), [EGFR mutation subtypes (exon 19 deletion, L858R, exon 20 insertion, T790M)](https://onco.cc/terms/egfr-mutation-subtypes/), [Tyrosine kinase inhibitor (TKI)](https://onco.cc/terms/tki-term/)
- trials: [ARCHER 1050](https://onco.cc/trials/nct01774721/), [FLAURA](https://onco.cc/trials/flaura/)

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