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Trial Title:
The Recurrence Gene Profiles of Adjuvant Osimertinib Therapy in Resected Non-Small-Cell Lung Cancer
NCT ID:
NCT06477055
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Recurrence
Osimertinib
Conditions: Keywords:
EGFR
Osimertinib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Osimertinib
Description:
Osimertinib, 80mg, po, qd.
Arm group label:
Experimental group
Summary:
This is a phase II, prospective, multicenter, study to evaluate the recurrence gene
profiles of adjuvant osimertinib therapy in resected EGFR-mutated NSCLC.
Detailed description:
This is aprospective, multicenter, phase II study to evaluate the recurrence gene
profiles of adjuvant osimertinib therapy in resected EGFR-mutated NSCLC. Approximately 60
NSCLC patients with EGFR-sensitive mutations (19del, L858R) who received adjuvant
osimertinib after complete resection were enrolled. The primary endpoint was to assess
the recurrence gene profiles of adjuvant Osimertinib therapy. The secondary endpoint was
to explore of subgroups recurrence gene profiles of different recurrence types (local
/distant) after adjuvant Osimertinib therapy and to describe the diverse treatment
patterns in real clinical practice after the disease progressed.
Criteria for 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.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Start date:
October 1, 2024
Completion date:
June 15, 2027
Lead sponsor:
Agency:
Hunan Province Tumor Hospital
Agency class:
Other
Source:
Hunan Province Tumor Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06477055
