Clinical trial NCT05822284: ctDNA-MRD in Stage IIIB-C NSCLC Patients Treated With Induction Chemoimmunotherapy
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Second Xiangya Hospital of Central South University
Sponsor class: OTHER
Collaborators: name: Geneplus-Beijing Co. Ltd.
First posted: 2023-04-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potentially resectable stage IIIB-C driver-negative NSCLC patients receiving induction chemoimmunotherapy

Brief summary: 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.

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

Primary outcomes:
measure: Predicting Progression Free Survival
timeFrame: up to 5 years
measure: Predicting pathologic complete response
timeFrame: Up to 1 year
measure: Predicting Overall Survival
timeFrame: up to 5 years
Secondary outcomes:
measure: Objective response rate(ORR)
timeFrame: Up to 1 year
measure: Adverse events (AEs)
timeFrame: Up to 5 years
measure: Perioperative complications rate
timeFrame: Up to 3 years
measure: Health-related Quality of Life
timeFrame: Up to 5 years
measure: Perioperative pain evaluation
timeFrame: Up to 3 years
measure: Lung cancer-related Quality of Life
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Changsha
country: China
facility: Department of Thoracic Surgery, Second Xiangya Hospital of Central South University, China
state: Hunan
Study officials:
References: