# Dacomitinib versus gefitinib as first-line treatment for patients with EGFR-mutation-positive non-small-cell lung cancer (ARCHER 1050): a randomised, open-label, phase 3 trial

Source: https://onco.cc/key-papers/paper-archer-1050-lancet-oncol-2017/  
OnCo record `paper-archer-1050-lancet-oncol-2017` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The primary report of ARCHER 1050: dacomitinib held untreated EGFR-mutant lung cancer for a median of 14.7 months against 9.2 months on gefitinib, at the cost of more rash and diarrhoea.

## Summary

International, multicentre, randomised, open-label phase 3 trial at 71 academic centres in seven countries or regions in adults with newly diagnosed advanced non-small-cell lung cancer and one EGFR mutation (exon 19 deletion or Leu858Arg). Patients were randomised 1:1 to oral dacomitinib 45 mg a day or gefitinib 250 mg a day, stratified by race and EGFR mutation type. The primary endpoint was progression-free survival by masked independent review in the intention-to-treat population.

Between May 2013 and March 2015, 452 patients were randomised (227 dacomitinib, 225 gefitinib). Median progression-free survival was 14.7 months (95% CI 11.1 to 16.6) with dacomitinib and 9.2 months (95% CI 9.1 to 11.0) with gefitinib (hazard ratio 0.59, 95% CI 0.47 to 0.74). The most common grade 3 to 4 adverse events on dacomitinib were dermatitis acneiform (14 percent) and diarrhoea (8 percent). Funded by SFJ Pharmaceuticals Group and Pfizer.

## Fields

- Kind: Key paper
- Last checked: 2026-09-24
- Journal: The Lancet Oncology
- Year: 2017
- DOI: 10.1016/S1470-2045(17)30608-3
- Authors: Wu YL, Cheng Y, Zhou X, et al.
- Findings: Median progression-free survival 14.7 vs 9.2 months by masked independent review; hazard ratio 0.59 (95% CI 0.47 to 0.74).; 452 patients randomised between May 2013 and March 2015; median follow-up for progression-free survival 22.1 months.; Grade 3 to 4 dermatitis acneiform in 14% and diarrhoea in 8% on dacomitinib.
- What it means: ARCHER 1050 supported dacomitinib's 2018 US first-line approval and was the first head-to-head win of a second-generation EGFR inhibitor over a first-generation one on progression-free survival. FLAURA, reported the same year, made osimertinib the usual first choice, so dacomitinib is now rarely used.
- Caveats: Open-label; patients with brain metastases were excluded, so the result does not speak to the commonest site of EGFR-mutant relapse.; Overall survival was reported separately (Mok 2018).; Dose reductions were needed in two thirds of dacomitinib patients according to the US label.

## Sources

- The Lancet Oncology 2017: https://doi.org/10.1016/S1470-2045(17)30608-3
- PubMed: https://pubmed.ncbi.nlm.nih.gov/28958502/
- ClinicalTrials.gov NCT01774721: https://clinicaltrials.gov/study/NCT01774721

## Connected records

- cancers: [EGFR-mutated non-small-cell lung cancer](https://onco.cc/cancers/egfr-mutant-nsclc/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- targets: [EGFR](https://onco.cc/targets/egfr/)
- drugs: [Dacomitinib](https://onco.cc/drugs/dacomitinib/), [Gefitinib](https://onco.cc/drugs/gefitinib/)
- companies: [Pfizer (incl. Seagen)](https://onco.cc/companies/pfizer/)
- trials: [ARCHER 1050](https://onco.cc/trials/nct01774721/)
- people: [Tony S. K. Mok](https://onco.cc/people/tony-mok/), [Yi-Long Wu](https://onco.cc/people/wu-yi-long/)
- journals: [The Lancet Oncology](https://onco.cc/journals/lancet-oncology/)

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