Genetic patterns in recurrences after adjuvant osimertinib for resected EGFR‑mutant lung cancer

A Multicenter, Real-World, Observational Study: Genomic Landscape of Recurrence in Early-Stage (Clinical Stage IB-IIIA) Non-Small Cell Lung Cancer (NSCLC) Patients With EGFR Sensitizing Mutations After Adjuvant Osimertinib Treatment

This study tests whether recurring tumors in adults with early-stage EGFR‑mutant non‑small cell lung cancer who received adjuvant osimertinib share specific genetic changes.

Quick facts

• Study type: Observational
• Enrollment: 60 (estimated)
• Sex: All
• Sponsor: Hunan Province Tumor Hospital (Academic / other)
• Drugs / interventions: osimertinib
• Locations: 2 sites (Changsha, Hunan and 1 other locations)
• Trial ID: NCT06477055 on ClinicalTrials.gov

What this trial studies

This is a multicenter, real‑world, retrospective observational study of 60 patients with resected stage IB–IIIA NSCLC harboring EGFR exon 19 deletions or exon 21 L858R mutations who received adjuvant osimertinib. Patients are divided into two cohorts: 30 with recurrence during adjuvant osimertinib and 30 with recurrence more than six months after completing three years of adjuvant therapy. Next‑generation sequencing of tissue and/or blood at recurrence will be used to characterize the genomic landscape and compare local versus distant recurrence patterns. The study will also describe real‑world treatment choices after progression and explore genomic changes from baseline to recurrence to suggest potential resistance mechanisms.

Who should consider this trial

Good fit: Adults (≥18) with resected non‑squamous stage IB–IIIA NSCLC harboring EGFR exon 19 deletion or exon 21 L858R who received adjuvant osimertinib and have NGS results at recurrence are ideal candidates.

Not a fit: Patients without EGFR‑sensitizing mutations, those who did not receive adjuvant osimertinib, or those lacking NGS data at recurrence are unlikely to benefit from the study findings.

Why it matters

Potential benefit: If successful, the results could help doctors choose targeted treatments after recurrence by identifying common resistance mutations that emerge following adjuvant osimertinib.

How similar studies have performed: Genomic studies in advanced EGFR‑mutant lung cancer have identified common resistance mechanisms, but systematic profiling specifically after adjuvant osimertinib is relatively novel.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients with stage I-III NSCLC whose surgical resection cannot be confirmed;
2. Received adjuvant therapy other than that specified in the ADAURA study;
3. No NGS test report at recurrence;
4. History of other malignant tumors within 2 years;
5. 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.

Where this trial is running

Changsha, Hunan and 1 other locations

• Hunan Provincal Tumor Hospital — Changsha, Hunan, China (Recruiting)
• The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Yongchang Zhang, MD

Conditions Non-small Cell Lung Cancer; EGFR; Osimertinib