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Poster Display session

130TiP - Adjuvant osimertinib in patients with completely resected, stage IB-IIIB non-small cell lung cancer with uncommon EGFR mutations: A phase II, open-label, single arm, multicenter, exploratory study


31 Mar 2023


Poster Display session


Chengwu Liu


Journal of Thoracic Oncology (2023) 18 (4S): S106-S115.


C. Liu1, J. Mei2, F. Lin2, Y. Lin3, Y. Chen3, L. Liu2

Author affiliations

  • 1 Sichuan/CN
  • 2 West China Hospital of Sichuan University, Sichuan/CN
  • 3 AstraZeneca, Shanghai/CN


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Abstract 130TiP


Epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKI) show decreased sensitivity and suboptimal treatment outcomes in non-small cell lung cancer (NSCLC) patients (pts) with uncommon EGFR mutations (EGFRm) compared to pts with common EGFRm. 2022 ‘ESMO expert consensus statements on the management of EGFR mutant non-small-cell lung cancer’ recommends osimertinib as the preferred first-line treatment for late-stage NSCLC pts with major uncommon EGFRm (G719X/L861Q/S768I). ADAURA study showed osimertinib adjuvant treatment has overwhelming DFS benefit among IB to IIIA NSCLC pts with complete tumor resection and optional, standard post-operative adjuvant chemotherapy. Data on adjuvant osimertinib treatment in NSCLC with uncommon EGFRm is not available. Hence, this study has been planned to evaluate the efficacy and safety of adjuvant osimertinib in completely resected NSCLC pts with uncommon EGFRm.

Trial design

This is a phase II, open-label, single-arm, multicenter, exploratory study conducting at 10 hospitals in China. 50 completely resected, histologically confirmed stage IB-IIIB non-squamous NSCLC pts with any uncommon EGFRm (G719X/L861Q/S768I/de novo T790M) but without EGFR Ex19del/L858R/exon 20 insertion, will be enrolled. Pts who have received prior neoadjuvant or adjuvant EGFR-TKI/radiotherapy/chemotherapy (except adjuvant platinum doublet chemotherapy) will be excluded. Pts will receive 80 mg osimertinib QD orally for a maximum of 3 years or until the discontinuation criterion is met. The primary endpoint is 3-year DFS rate by investigator assessment. Secondary endpoints include DFS rates at 2, 4, and 5 years and overall survival (OS) rates at 2, 3, 4, and 5 years. Safety assessments include adverse events, physical examinations, vitals, electrocardiogram, echocardiogram and clinical laboratory assessments. Exploratory analysis of tumor and blood samples will be performed in a retrospective manner to investigate the molecular mechanism of recurrence. Trial recruitment is ongoing and the first patient is anticipated to be enrolled in Feb 2023.

Clinical trial identification


Editorial acknowledgement

Medical writing support was provided by Ramandeep Singh of Indegene and was funded by AstraZeneca.

Legal entity responsible for the study





Y. Lin: Non-Financial Interests, Institutional, Full or part-time Employment, The author declares employment at AstraZeneca and has no AstraZeneca stock ownership: AstraZeneca. Y. Chen: Non-Financial Interests, Institutional, Full or part-time Employment, The author declares employment at AstraZeneca and has no AstraZeneca stock ownership: AstraZeneca. All other authors have declared no conflicts of interest.

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