NCT06477055 The Recurrence Gene Profiles of Adjuvant Osimertinib Therapy in Resected Non-Small-Cell Lung Cancer
| NCT ID | NCT06477055 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hunan Province Tumor Hospital |
| Condition | Non-small Cell Lung Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-12-02 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2025-12-02 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06477055 clinical trial?
This trial is open to participants of all sexes, studying Non-small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06477055 currently recruiting?
Yes, NCT06477055 is actively recruiting participants. Contact the research team at zhangyongchang@csu.edu.cn for enrollment information.
Where is the NCT06477055 trial being conducted?
This trial is being conducted at Changsha, China, Hangzhou, China.
Who is sponsoring the NCT06477055 clinical trial?
NCT06477055 is sponsored by Hunan Province Tumor Hospital. The trial plans to enroll 60 participants.
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