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Not yet recruiting NCT05822284

ctDNA-MRD in Stage IIIB-C NSCLC Patients Treated With Induction Chemoimmunotherapy

— Observational Non-small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NGS and ctDNA-MRD detection.
Who it may be relevant to
Registry conditions: Non-small Cell Lung Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Role of Dynamic Circulating Tumor DNA-Molecular Residual Disease (ctDNA-MRD) Testing in Stage IIIB-C Oncogene-negative NSCLC Patients Treated With Induction Chemoimmunotherapy in the Multidisciplinary Team (MDT) Model of Diagnosis and Treatment

Overview

The goal of this observational study is to explore whether ctDNA-MRD dynamic monitoring can more effectively predict the therapeutic effect of induction chemoimmunotherapy followed by surgery or non-surgical treatment for stage IIIB-C driver-negative NSCLC in the MDT model, so as to accurately guide clinical diagnosis and treatment.

Detailed description

This study is a single-center, observational, non-interventional, prospective study. 50 patients diagnosed with stage IIIB-C driver-negative NSCLC receiving induction chemoimmunotherapy will be planned to be enrolled in the study. Pre-treatment biopsy tissues of enrolled patients will be collected for next-generation sequencing (NGS) of institutionally-developed 1021-gene panel, and personalized detection panel will be customized based on NGS testing results. Patients will be received induction chemoimmunotherapy followed by surgery or non-surgical treatment in the MDT model and ctDNA-MRD testing will be performed at prespecified time points. For patients who received surgery following induction therapy, peripheral blood will be collected in baseline, 1 day before the third cycle of neoadjuvant therapy, 1 day before surgery, 3 days after surgery and landmark time and pulmonary venous blood will be collected intraoperatively. For patients who received non-surgical treatment following induction therapy, peripheral blood will be collected in baseline, 1 day before the third cycle of neoadjuvant therapy, 1 day before non-surgical therapy and landmark time. All included patients will be regularly followed up for at least 5 years.

Interventions

  • Diagnostic test NGS and ctDNA-MRD detection
    NGS and ctDNA-MRD detection

Primary outcome measures

  • Predicting Progression Free Survival [Time frame: up to 5 years]
  • Predicting pathologic complete response [Time frame: Up to 1 year]
  • Predicting Overall Survival [Time frame: up to 5 years]
Secondary outcome measures (6)
  • Objective response rate(ORR) [Time frame: Up to 1 year]
  • Adverse events (AEs) [Time frame: Up to 5 years]
  • Perioperative complications rate [Time frame: Up to 3 years]
  • Health-related Quality of Life [Time frame: Up to 5 years]
  • Perioperative pain evaluation [Time frame: Up to 3 years]
  • Lung cancer-related Quality of Life [Time frame: Up to 5 years]

Eligibility criteria

Inclusion criteria

  • Histopathology or cytology confirmed the non-small cell lung cancer
  • Age ranging from 18 to 75
  • Agree to participate in this study and sign an informed consent form
  • Treatment-naive tumor
  • Driver gene negativity
  • According to the American Joint Committee on Cancer (AJCC) eighth edition of the Lung Cancer Staging Manual, the clinical stage is stage IIIB-C potentially resectable tumor
  • The Eastern Cooperative Oncology Group (ECOG) performance status (PS) score is 0-1

Exclusion criteria

  • Patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent form
  • Small cell lung cancer
  • Driver gene positivity
  • Tumor directly invades esophagus, heart, aorta, diaphragm, trachea, or carina, or is considered unresectable even following induction therapy
  • Patients with solid organ or blood system transplantation
  • Previous use of recombinant cytotoxic T-lymphocyte associated antigen 4 (CTLA-4), programmed cell death 1 (PD-1), or programmed cell death ligand 1 (PD-L1) immune checkpoint inhibitors
  • Patients with interstitial lung disease
  • Patients with acute or chronic infectious disease
  • Pregnant and lactating women
  • Patients who have undergone other clinical drug trials

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Department of Thoracic Surgery, Second Xiangya Hospital of Central South University, China — Changsha

Identifiers

NCT: NCT05822284 · LYF2023026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗