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Adjuvant aumolertinib in resected EGFR-mutant NSCLC: phase 3 ARTS trial

In Chinese patients with completely resected stage II–IIIA disease, investigators reported improved disease-free survival with adjuvant aumolertinib versus placebo; overall survival was not reported.

  • Liang Zhang, MD; Xiqin Zhang, BS; Lin Wu, MD; Wenqun Xing, BS; Chunling Liu, MS; Peng Zhang, MD; et al.

  • January 12, 2026

  • The Lancet Oncology
  • The Lancet Oncology, Volume 27, Issue 2, Pages 159–168
  • 10.1016/S1470-2045(25)00643-6

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Evidence before this study

Patients with resectable non-small-cell lung cancer (NSCLC) remain at significant risk of recurrence and mortality despite surgical resection. Traditional adjuvant chemotherapy offers modest survival benefits, but recurrence risk remains high, especially among patients with an EGFR mutation. Before this study, osimertinib became the global standard of care for resected EGFR-mutant NSCLC based on the ADAURA trial, which demonstrated significant improvement in disease-free survival and overall survival for patients with stage IB–IIIA disease. Notably, although the EGFR mutation rate in the Chinese population with NSCLC is as high as 39–58%, pivotal trials such as ADAURA demonstrated under-representation of this crucial subgroup (23% Chinese representation).

We did a systematic search of PubMed from database inception to July 24, 2025, using the terms “non-small cell lung cancer”, “tyrosine kinase inhibitor”, “adjuvant therapy” and “epidermal growth factor receptor”, with no language restrictions. Our search identified 43 studies, which showed persistent crucial gaps: despite the higher prevalence of EGFR mutations in Chinese populations, their representation in trials of tyrosine-kinase inhibitor as adjuvant therapy remains inadequate.

Aumolertinib, a novel oral, irreversible, third-generation tyrosine-kinase inhibitor has been approved in China for first-line treatment of adult patients with locally advanced or metastatic NSCLC who have EGFR exon 19 deletions or exon 21 (Leu858Arg) mutations (December, 2021) and for the treatment of patients with locally advanced or metastatic NSCLC with EGFR Thr790Met mutation after progression on previous EGFR tyrosine-kinase inhibitor therapy (March, 2020). Aumolertinib showed promise in a Chinese patient population with advanced NSCLC in the AENEAS trial (), though robust phase 3 evidence supporting its use as an adjuvant treatment was scarce.

Added value of this study

Our study (ARTS ) was designed to address the evidence gaps by directly comparing adjuvant aumolertinib with placebo in patients with completely resected stage II–IIIA NSCLC. As the first randomised, phase 3 trial focusing on Chinese patients with resected EGFR-mutant NSCLC, this study establishes aumolertinib as an effective adjuvant option, showing improved disease-free survival compared with placebo. These pivotal findings directly supported the Chinese National Medical Products Administration approval of aumolertinib as an adjuvant therapy in patients with NSCLC harboring EGFR ex19del or Leu858Arg mutations (May, 2025).

Implications of all the available evidence

The available data provide a rationale for further investigation of adjuvant EGFR tyrosine-kinase inhibitors in resected stage II–IIIB EGFR-mutant NSCLC and offer a new therapeutic option for postoperative adjuvant EGFR-targeted therapy. The ARTS study provides valuable evidence to guide the use of EGFR tyrosine-kinase inhibitors in clinical practice and the treatment of Chinese participants with stage II–IIIB EGFR-mutated NSCLC. These data reinforce the role of aumolertinib as an effective option for adjuvant therapy, showing consistent efficacy in Chinese patients.

Source: The Lancet Oncology

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