Clinical trial · Observational
The Recurrence Gene Profiles of Adjuvant Osimertinib Therapy in Resected Non-Small-Cell 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Cohort 1
- description
- consists of 30 patients who experienced a recurrence more than 6 months after completing 3 years of adjuvant osimertinib.
- label
- Cohort 2
- description
- consists of 30 patients with recurrence during adjuvant osimertinib treatment.
Primary outcomes (1)
- measure
- Recurrence gene profiles
- timeFrame
- From January 2021 to March 2026, assessed retrospectively from medical records.
- description
- To assess the recurrence gene profiles of adjuvant Osimertinib therapy
Secondary outcomes (2)
- measure
- Recurrence gene profiles in patients with different recurrence types (local /distant)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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; 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.
References
Publications (0)
Data not yet available