Liquid Biopsy in Advanced Oligometastatic NSCLC Receiving Surgery

Recruiting

• Conditions: Oligometastatic Disease; Non-small Cell Lung Cancer
• Interventions: Genetic: ctDNA testing and whole exome sequencing

• Registration Number: NCT05648370
• Lead Sponsor: Guangdong Provincial People's Hospital

Brief Summary

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

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 Timeline

• Status Verified: 2022-07
• Study Start: 2022-07-01
• Study First Submitted: 2022-12-05
• Study First Submitted QC: 2022-12-05
• Last Update Submitted: 2022-12-05
• Study First Posted: 2022-12-13
• Last Update Posted: 2022-12-13
• Primary Completion: 2024-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
oligometastatic disease	ctDNA testing and whole exome sequencing	Dynamic blood samples before and after surgery and tissue samples from oligometastatic NSCLC undergone surgery will be obtained for exploratory analysis.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences; 🇨🇳 Guangzhou, Guangdong, China