An interventional study of ctDNA monitoring in EGF-R Positive Non-Small Cell Lung Cancer, sponsored by Zhejiang University. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-04-24.
Sponsored by Zhejiang University · Not applicable, Interventional, and Treatment
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.
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.
Zhejiang University is the lead sponsor of 355 studies on the registry; 165 are open to participants now.
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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
Exclusion Criteria:
For patients with negative ctDNA after 3 weeks of neoadjuvant TKI treatment, radical resection surgery will be performed after continuing TKI treatment for 9-12 weeks.
Other: ctDNA monitoring
For patients with positive ctDNA after 3 weeks of neoadjuvant TKI treatment, radical resection surgery will be performed after continuing TKI treatment for 9-12 weeks.
Other: ctDNA monitoring
For patients with positive ctDNA after 3 weeks of neoadjuvant TKI treatment, radical resection surgery will be performed after 3 cycles of TKI plus chemotherapy.
Other: ctDNA monitoring
For patients with positive ctDNA after 3 weeks of neoadjuvant TKI treatment, radical resection surgery will be performed after 3 cycles of sequential neoadjuvant PD-1 blockades plus chemotherapy.
Other: ctDNA monitoring
Patients will receive ctDNA monitoring before and after 3 weeks of neoadjuvant 3rd TKI treatment and optimize the neoadjuvant treatment plan based on this.
the rate of major pathological response (MPR)
the proportion of patients who achieve MRP among those receiving pneumonectomy
Time frame: up to 17 weeks
the rate of pathological complete response (pCR)
the proportion of patients who achieve pCR among those receiving pneumonectomy
Time frame: up to 17 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Apr 2024; primary completion for Dec 2026, 32 months later.
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This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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