The Feasibility of Dynamic Liquid Biopsy Monitoring During Neoadjuvant Treatment for EGFR-mutated NSCLC

ConditionEGF-R Positive Non-Small Cell Lung Cancer

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorZhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients should voluntarily join this study and sign the informed consent form

Patients diagnosed with resectable stage II-IIIB (T1-4N0-2M0, excluding T4 with invasion of vital structures and bulky or infiltrative N2) NSCLC

Patients with EGFR 19del or L858R mutations.

Age from 18 to 75 years old, both male and female

Disqualifiers

Patients with other primary malignancies within the past 3 years (excluding cured skin basal cell carcinoma and cervical carcinoma in situ)

Patients with active hepatitis B/C

Patients with any active autoimmune diseases or a history of autoimmune diseases

Patients who are using immunosuppressive agents or require systemic hormone therapy

Trial design

Design model

Single group

Treatments tested in this trial

ctDNA monitoring
Other intervention
Patients will receive ctDNA monitoring before and after 3 weeks of neoadjuvant 3rd TKI treatment and optimize the neoadjuvant treatment plan based on this.

Treatment groups

300 Participants

are divided into 4 treatment groups

Group A: group AOther 1 intervention

Group B: group BOther 1 intervention

Group C: group COther 1 intervention

Group D: group DOther 1 intervention

Trial outcomes

Primary outcomes

the rate of major pathological response (MPR)

the proportion of patients who achieve MRP among those receiving pneumonectomy

Time frame

up to 17 weeks

Secondary outcomes

the rate of pathological complete response (pCR)

the proportion of patients who achieve pCR among those receiving pneumonectomy

Time frame

up to 17 weeks

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhejiang University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: