Liquid Biopsy in Advanced Oligometastatic NSCLC Receiving Surgery

A prospective, observational study that assesses the clinical feasibility of ctDNA-based liquid biopsy in patients with oligometastatic NSCLC receiving surgery.

Study Overview

• Status: Recruiting
• Conditions: Non-small Cell Lung Cancer; Oligometastatic Disease
• Intervention / Treatment: Genetic: ctDNA testing and whole exome sequencing

Detailed Description

60 eligible patients will be enrolled. Dynamic blood samples before and after surgery and tissue samples will be obtained for exploratory analysis.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Wen-Zhao Zhong, Ph.D; Phone Number: +86 02083827812; Email: syzhongwenzhao@scut.edu.cn
• Study Contact Backup: Name: Rui Fu, M.D.; Phone Number: +86 02083827812; Email: ruifu66@foxmail.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences
      • Contact: Wen-Zhao Zhong, Ph.D; Phone Number: +86 02083827812; Email: syzhongwenzhao@scut.edu.cn
      • Contact: Rui Fu, M.D.; Phone Number: +86 02083827812; Email: ruifu66@foxmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Stage IV NSCLC patients with oligometastases at initial diagnosis or oligoresidual or oligoprogression or oligorelapses after systemic therapy

Description

Inclusion Criteria:

• Written informed consent must be obtained from patients and ability for patients to comply with the requirements of the study；
• Patients must be a man or woman of more than 18 years;
• ECOG PS ≦1；
• The function of the organs was evaluated by the surgeon to tolerate local surgical treatment；
• The classification was evaluated as simultaneous oligometastases at initial treatment or oligoresidual/oligoprogression/oligorecurrence after induction therapy; [Define: Initial treatment of simultaneous oligometastases: without systemic treatment, at the time of diagnosis, up to 5 metastases and up to 3 organs were involved, excluding pleural metastases or myeloid metastases.

Oligoresidual after induction therapy: after systemic therapy, distant metastases were stable or reduced, primary lesions were stable or reduced, PET/CT metabolism was reduced, and no more than 5 residual lesions and no more than 3 organs were involved.

Oligoprogression after induction therapy: After systemic therapy, some lesions were stable or reduced, while some original lesions were larger than before.

Oligorelapses after induction therapy: after systemic therapy, systemic lesions were stable or reduced, and new local lesions appeared.]

• Lesion evaluation can be surgically removed. [Definition of operable resection: the lesion is limited and can be completely removed through surgery as assessed by the surgeon, with no significant impact on postoperative quality of life. Pulmonary surgical procedures include lobectomy, segmental resection and wedge resection. Pneumonectomy is not included.]

Exclusion Criteria:

• Patients with a confirmed or suspected autoimmune disease;
• Patients with a history of human immunodeficiency virus (HIV) positive or acquired immunodeficiency syndrome (AIDS);
• Patients with a history of any arterial thrombosis within 6 months and history of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolism within 3 months;
• Patients with any unstable systemic disease (eg, active infection, high-risk hypertension, unstable angina, congestive heart failure, etc.);
• Patients with a history of other malignancies in the past 5 years;
• Patients identified by the investigators patients with contraindications to local treatment;
• Patients with serious mental illness;
• Patients who cannot sign informed consent;
• Patients who cannot be followed up as scheduled;

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
oligometastatic disease; Dynamic blood samples before and after surgery and tissue samples from oligometastatic NSCLC undergone surgery will be obtained for exploratory analysis.	Genetic: ctDNA testing and whole exome sequencing; Blood samples will be obtained for ctDNA testing and tumor tissue for whole exome sequencing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between perioperative ctDNA-MRD characteristics and rogression-free survival	To explore the potential association among perioperative ctDNA-MRD characteristics and rogression-free survival within 2 years.	2-year PFS
Construction of a survival-prediction model	The survival-prediction model based on clinicopathological and genomic characteristics.	Through study completion, up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association among ctDNA status before surgery, systemic treatment times, and survival	To explore the potential association among plasma ctDNA status surgery, systemic treatment time duration, PFS and OS.	Through study completion, up to 5 years
Genomic characteristics and clonal evolution after systemic treatment	Using whole-exome sequencing to identify genomic characteristics and clonal evolution after systemic treatment	Through study completion, up to 5 years
Potential drug-resistance mechanism identified by plasma ctDNA	Using plasma ctDNA-MRD to identify the potential drug-resistance mechanism.	Through study completion, up to 5 years
Assess whether ctDNA-MRD is associated with radiological and pathological response after systematic therapy before surgery	Association among perioperative ctDNA-MRD characteristics, imaging response, and pathological response.	60 patients underwent surgery
Heterogeneity in Genomic and transcriptome between primary and metastatic tumors	Using whole-exome sequencing and whole transcriptome sequencing to identify genomic and transcriptome heterogeneity between primary and metastatic tumors.	60 patients underwent surgery

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital
• Investigators: Principal Investigator: Wen-Zhao Zhong, Ph.D, Guangdong Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): June 30, 2025

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: December 5, 2022
• First Posted (Actual): December 13, 2022

Study Record Updates

• Last Update Posted (Actual): December 13, 2022
• Last Update Submitted That Met QC Criteria: December 5, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: LB4S

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No