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

NCT06287593 | Not Yet Recruiting

• 1 other identifier: NeoLiq
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

EGF-R Positive Non-Small Cell Lung Cancer

Keywords

EGFR positive resectable NSCLC; ctDNA

Outcome Measures

Primary Outcomes (1)

• the rate of major pathological response (MPR)

  the proportion of patients who achieve MRP among those receiving pneumonectomy

  up to 17 weeks

Secondary Outcomes (1)

• the rate of pathological complete response (pCR)

  up to 17 weeks

Study Arms (4)

group A

OTHER

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

group B

OTHER

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

group C

OTHER

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

group D

OTHER

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

Interventions

ctDNA monitoring OTHER

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

group A; group B; group C; group D

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• ECOG score 0-1
• According to the RECIST v1.1 , patients should have at least one measurable lesion
• 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
• According clinical evaluation, the lung function of patients (such as FVC, FEV1, TLC, FRC, DLco, etc.) should be sufficient for pneumonectomy
• 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
• 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

You may not qualify if:

• 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
• Patients with hypertension but without good control even through antihypertensive medication treatment ; patients with clinical symptoms or diseases related to unsatisfying cardiac function
• Patients with abnormal coagulation function (INR\>2.0, PT\>16s)
• Arterial/venous thrombotic events occurred before screening within 6 months
• Patients with active infection
• Patients with congenital or acquired immune dysfunction (such as HIV infection)
• 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

Sponsors & Collaborators

• Zhejiang University: lead

Study Officials

• Weijia Fang, MD

  The First Affiliated Hospital, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuqi Sun, MD

CONTACT

+86-18767186629; sunxq@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 1, 2024
• Study Start: April 15, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share