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Trial Title:
The Feasibility of Dynamic Liquid Biopsy Monitoring During Neoadjuvant Treatment for EGFR-mutated NSCLC
NCT ID:
NCT06287593
Condition:
EGF-R Positive Non-Small Cell Lung Cancer
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
EGFR positive resectable NSCLC
ctDNA
Study type:
Interventional
Study phase:
N/A
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:
Other
Intervention name:
ctDNA monitoring
Description:
Patients will receive ctDNA monitoring before and after 3 weeks of neoadjuvant 3rd TKI
treatment and optimize the neoadjuvant treatment plan based on this.
Arm group label:
group A
Arm group label:
group B
Arm group label:
group C
Arm group label:
group D
Summary:
This study aimed to assess the value of dynamic ctDNA monitoring in guiding the
development of personalized neoadjuvant treatment strategies for EGFR-mutated NSCLC
patients.
Detailed description:
This study aimed to prospectively enroll approximately 300 resectable stage II-IIIB
(T1-4N0-2M0, excluding T4 with invasion of vital structures and bulky or infiltrative N2)
NSCLC patients with histologically confirmed EGFR 19del or L858R mutations. Peripheral
blood samples will be collected at baseline before neoadjuvant 3rd-generationEGFR TKI
therapy, and ctDNA levels will be quantitatively assessed. For patients with positive
baseline ctDNA, peripheral blood will be collected again after 3 weeks of neoadjuvant TKI
therapy to assess if ctDNA has turned negative, and HRCT will be performed to evaluate
the treatment efficiency simultaneously.
In patients with positive baseline ctDNA, for ctDNA-negative patients after 3 weeks of
neoadjuvant TKI treatment, radical resection surgery will be performed after continuing
TKI treatment for 9-12 weeks (Group A). For ctDNA-positive patients after 3 weeks of
neoadjuvant TKI treatment, in combination with imaging changes in the lesions, a
multidisciplinary team (MDT) evaluation will be conducted. After discussion between the
attending physicians and the patient, the subsequent treatment will either continue TKI
treatment for 9-12 weeks (Group B), undergo 3 cycles of TKI plus chemotherapy (Group C),
or undergo sequential neoadjuvant immunotherapy plus chemotherapy for 3 cycles (Group D)
before radical resection surgery.The study intends to evaluate the correlation between
the rate of major pathological response (MPR) and ctDNA levels at 3 weeks after TKI
treatment, to compare the difference in pathological response between ctDNA-negative and
ctDNA-positive groups after 3 weeks of neoadjuvant TKI treatment and to evaluate the
guiding value of dynamic ctDNA monitoring during neoadjuvant therapy for optimizing
subsequent treatments.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients should voluntarily join this study and sign the informed consent form
2. Patients diagnosed with resectable stage II-IIIB (T1-4N0-2M0, excluding T4 with
invasion of vital structures and bulky or infiltrative N2) NSCLC
3. Patients with EGFR 19del or L858R mutations.
4. Age from 18 to 75 years old, both male and female
5. ECOG score 0-1
6. According to the RECIST v1.1 , patients should have at least one measurable lesion
7. For suspicious mediastinal lymph nodes (including pathological enlargement or PET-CT
indicating malignancy, etc.), further sampling is required for pathological
diagnosis by EUBS, thoracoscopy, or mediastinoscopy
8. According clinical evaluation, the lung function of patients (such as FVC, FEV1,
TLC, FRC, DLco, etc.) should be sufficient for pneumonectomy
9. The function of important organs should meet the following requirements: absolute
count of neutrophils ≥ 1.5 × 109/L# Platelets
≥ 100 × 109/L# Hemoglobin ≥ 90g/L; Serum albumin ≥ 35g/L; Thyroid hormone (TSH) ≤ 1
× ULN# Serum bilirubin ≤ 1.5 × ULN# ALT and AST ≤ 3 × ULN# International
standardized ratio (INR) ≤ 1.5 or prothrombin time (PT) ≤ 1.5 × ULN# Serum
creatinine ≤ 1.5 × ULN
10. Female patients at childbearing age are required to use contraceptive measures; for
male patients whose partners are women at childbearing age, effective methods of
contraception should be used during the trial period
Exclusion Criteria:
1. Patients with other primary malignancies within the past 3 years (excluding cured
skin basal cell carcinoma and cervical carcinoma in situ)
2. Patients with active hepatitis B/C
3. Patients with any active autoimmune diseases or a history of autoimmune diseases
4. Patients who are using immunosuppressive agents or require systemic hormone therapy
5. Patients with hypertension but without good control even through antihypertensive
medication treatment ; patients with clinical symptoms or diseases related to
unsatisfying cardiac function
6. Patients with abnormal coagulation function (INR>2.0, PT>16s)
7. Arterial/venous thrombotic events occurred before screening within 6 months
8. Patients with active infection
9. Patients with congenital or acquired immune dysfunction (such as HIV infection)
10. According to the judgment of the researchers, patients have other factors that may
affect the results of the research or cause the research to be terminated
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
April 15, 2024
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Zhejiang University
Agency class:
Other
Source:
Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06287593