Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Carcinoma, Non-Small-Cell Lung

Carcinoma

Lung Neoplasms

Neoplasm, Residual

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Neoplastic Processes

ctDNA positivity in pretreatment and posttreatment plasma samples was defined by accessing the presence of one or more mutations identified in match tumor samples. A mutation was considered present when at least one consensus read contained the mutation and passed the local polishing pipeline. The MRD positive cohort was randomly divided into two groups, one group for interventional treatment and the other group for observation.

ctDNA negative in pretreatment and posttreatment plasma samples was defined by accessing the presence of no mutation identified in match tumor samples. According to the clinical prognostic characteristics of the MRD negative group, the clinician decides to observe or treat.

Patients with stage IB-IIA NSCLC after curative surgery were treated with adjuvant chemotherapy. The blood samples of the patients before and after adjuvant chemotherapy will be collected to examine the MRD status

Adjuvants, Pharmaceutic

Yunfeng Ni

Tao Jiang, MD

Yunfeng Ni, MD

Tao Jiang

This clinical trial aims to explore the minimal residual disease (MRD) status of early NSCLC after curative surgery and the clinical outcomes of adjuvant chemotherapy. Next-generation sequencing technique will be used to examine the circulating tumor DNA (ctDNA) from MRD of 150 postoperative patients with stage IB-IIA NSCLC who received adjuvant chemotherapy.

Minimal residual disease (MRD) refers to the small number of malignant cells that remain after curative treatments (curative intent surgical resection, radiotherapy, and/or chemotherapy). MRD is common in patients with blood cancer, and is known to be associated with recurrence and poor prognosis. Recent studies also reported that MRD-negative in postoperative solid tumors such as colorectal/colon cancer and breast cancer is associated with better survival outcomes. However, the clinical values of MRD monitoring for adjuvant therapy in postoperative NSCLC remain inadequate.

Circulating tumor DNA (ctDNA), a type of cell-free DNA, refers to the DNA fragments that are derived from tumor cells and circulate in the blood. Recently, next-generation sequencing (NGS) was successfully applied to monitor NPM1, RUNX1 and FLT3 mutations in multiple myeloma. Thus, NGS technique is a promising tool for sensitive MRD monitoring, which provides the ctDNA profiling from MRD, and then provides future decision-making treatment for postoperative NSCLC patients. Thus, this clinical study aims to monitor the ctDNA status of MRD, and to explore the clinical value of MRD monitoring in decision-making adjuvant therapy for patients with stage IB-IIA NSCLC after curative surgery.

A total of 150 patients with primary curable stage IB-IIA NSCLC will be recruited in this clinical trial. The following samples will be collected from each patient including 1) preoperative blood samples; 2) surgical tissue samples; 3) blood samples 3-7 days after surgery; 4) blood samples every 3-6 month during adjuvant chemotherapy; and 5) white blood control samples. In addition, demographic and tumor characteristics of the patients will be collected for subsequent analysis, including age, sex, tumor stage, pathological stage, disease couse time, PS score, etc. NGS will be used to analyze the whole exons of potential driver genes to obtain the MRD status. Statistical analyses will be performed to analyze the survival outcomes of MRD-positive and MRD-negative group and to explore the clinical value of MRD monitoring for adjuvant therapy in postoperative NSCLC.

Circular DNA from the blood samples of NSCLC patients before and after adjuvant chemotherapy were collected and examined by NGS

Clinical Value of MRD Monitoring for Adjuvant Therapy in Postoperative NSCLC

Utility of ctDNA In Predicting Whether Giving Adjuvant Chemotherapy In Patients With Stage IB-IIA Resected Non-small Cell Lung Cancer: A Prospective Cohort Study

DFS defined as the time from randomization to occurrence of any of the following events, whichever occurs first:

Locoregional recurrence or distant metastases as determined by an independent central radiology assessment.

Occurrence of the second primary (same or other) cancer as determined by an independent central radiology assessment.

Death from any cause. Loss to follow-up is censored.

Change of Circulating tumor DNA (ctDNA) status (every 3 months)

Occurrence of treatment emergent adverse event (TEAE)

Occurrence of dose reduction and discontinuation of IMP due to a TEAE

Follow-up of the patients will be conducted to analyze 3-year and 5-year overall survival

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Clinical Value of MRD Monitoring for Adjuvant Therapy in Postoperative NSCLC	NCT05167604	Carcinoma, Non-... Next-Generation... Chemotherapy, A... Neoplasm, Resid... Circulating Tum...	Adjuvants, Phar...	18 Years - 70 Years	Tang-Du Hospital
Clinical Value of MRD Monitoring for Adjuvant Therapy in Postoperative NSCLC	NCT05167604	Carcinoma, Non-... Next-Generation... Chemotherapy, A... Neoplasm, Resid... Circulating Tum...	Adjuvants, Phar...	18 Years - 70 Years	Tang-Du Hospital

Spots Global Cancer Trial Database for adjuvants, pharmaceutic