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Trial Title:
Adjuvant Target Therapy Guided by ctDNA-MRD in Patients With EGFR-mutant II-IIIA Non-small Cell Lung Cancer (ECTOP-1022)
NCT ID:
NCT06323148
Condition:
Lung Cancer
EGFR Gene Mutation
Minimal Residual Disease
Conditions: Official terms:
Lung Neoplasms
Neoplasm, Residual
Osimertinib
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Osimertinib
Description:
Adjuvant osimertinib for three years after radical surgery
Arm group label:
ct-DNA-positive patients receiving adjuvant osimertinib
Intervention type:
Drug
Intervention name:
No adjuvant therapy
Description:
No adjuvant therapy
Arm group label:
ct-DNA-positive patients receiving no adjuvant osimertinib
Summary:
This study plans to conduct ctDNA testing on EGFR mutation-positive stage II-IIIA (N1-N2)
NSCLC patients after radical surgery (R0 resection). Patients with positive ctDNA testing
will receive standard treatment according to clinical guidelines, while patients with
negative ctDNA testing will be assessed based on comprehensive clinical and pathological
characteristics. After receiving or not receiving standard adjuvant chemotherapy,
patients will be randomly assigned in a 1:1 ratio to either the observation follow-up
group (experimental group) or the osimertinib adjuvant treatment group (control group).
The aim is to explore whether observation follow-up for patients with negative ctDNA
after surgery has a prognosis non-inferior to osimertinib treatment, and to investigate
the disease-free survival rate of EGFR mutation-positive stage II-IIIA (N1-N2) NSCLC
patients with positive ctDNA after surgery receiving osimertinib adjuvant treatment,
providing more precise treatment guidance for adjuvant therapy in this specific type of
NSCLC patients with EGFR mutation-positive tumors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age greater than 18 years old, both males and females are eligible.
2. Histologically confirmed diagnosis of non-small cell lung cancer.
3. Diagnosis of stage II-IIIA (N1-N2) non-small cell lung cancer based on the 8th
edition TNM staging guidelines combined with radiological evaluation.
4. EGFR mutation-positive status confirmed through molecular testing (such as ARMS-PCR
or high-throughput sequencing), specifically with mutations 19del or 21L858R.
5. Able to undergo R0 surgical resection.
6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1.
Expected survival of more than 12 months.
7. Baseline blood routine and biochemical indicators meeting the following criteria:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L;
- Lymphocyte count ≥ 0.5 × 10^9/L;
- Platelet count ≥ 100 × 10^9/L;
- Hemoglobin ≥ 9 g/dL.
- Total bilirubin ≤ 1.5 times the upper limit of normal (ULN);
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline
phosphatase (ALP) ≤ 2.5 times ULN.
8. Patients must provide informed consent, either directly or through their legally
authorized representatives, after being informed about the study.
Exclusion Criteria:
1. Pathological diagnosis of mixed-type lung cancer (including a history of small cell
lung cancer or non-adenocarcinoma).
2. Received anti-tumor therapy before surgery (including radiotherapy, chemotherapy,
targeted therapy, immunotherapy, etc.).
3. Rx, R1, R2 surgical resection.
4. Received blood transfusion during surgery or within 2 weeks before surgery.
5. Pregnant or lactating female patients.
6. History of other malignant tumors within the past 5 years, except for cases where
other malignant tumors have been cured solely through surgery with a disease-free
interval of at least 10 years, curable basal cell carcinoma of the skin, and
cervical carcinoma in situ.
7. Any unstable systemic diseases (including active infections, uncontrolled
hypertension, unstable angina pectoris, congestive heart failure, myocardial
infarction within the past year, severe arrhythmias requiring medication, liver,
kidney, or metabolic diseases).
8. Evidence of any other diseases, neurological or metabolic functional disorders,
physical examination findings, or laboratory findings that would place the subject
at high risk of treatment-related complications.
9. Other factors deemed by the investigators to potentially affect the study process.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
April 1, 2024
Completion date:
March 31, 2029
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06323148