RecruitingNot Applicable

The Recurrence Gene Profiles of Adjuvant Osimertinib Therapy in Resected Non-Small-Cell Lung Cancer

China60 participantsStarted 2025-12-02

Plain-language summary

This study was a multicenter, real-world observational study aimed at characterizing the genomic landscape of recurrence in patients with EGFR-sensitizing mutation-positive early-stage (clinical stage IB-IIIA) non-small cell lung cancer who received adjuvant osimertinib after surgery.

Who can participate

SexALL

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Inclusion criteria

✓. Informed consent signed;
✓. Age ≥ 18 years;
✓. Histologically confirmed diagnosis of non-squamous non-small cell lung cancer;
✓. Patients with stage IB-IIIA (TNM 8#) NSCLC undergo confirmed radical R0 resection;
✓. Confirmed EGFR sensitive-mutations (exon 19 deletions, 21 L858R point mutations) prior to adjuvant osimertinib therapy;
✓. Recurrence after/on Osimertinib treatment according to RECIST 1.1;
✓. NGS gene test report (tumor or blood sample) at the time of recurrence;
✓. Receiving or not receiving neoadjuvant treatment before surgery.

Exclusion criteria

✕. Patients with stage I-III NSCLC whose surgical resection cannot be confirmed;
✕. Received adjuvant therapy other than that specified in the ADAURA study;
✕. No NGS test report at recurrence;
✕. History of other malignant tumors within 2 years;
✕. Patients assessed by the investigator as unfit for enrollment, such as neurological disorders or metabolic disorders, physical examination or laboratory examination suspected that the patient has a possible disease, or has treatment-related complications High risk etc.

What they're measuring

Recurrence gene profiles

Timeframe: From April 1, 2021 to May 31, 2025, assessed retrospectively from medical records.

Trial details

NCT IDNCT06477055

SponsorHunan Province Tumor Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-03-31

Contact for this trial

Yongchang Zhang, MD

13873123436 zhangyongchang@csu.edu.cn

View on ClinicalTrials.gov More Non-small Cell Lung Cancer trials