Liquid Biopsy in Advanced Oligometastatic NSCLC Receiving Surgery

Non-small Cell Lung Cancer Clinical Trial

Official title:

Liquid Biopsy in Advanced Oligometastatic NSCLC Receiving Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05648370
• Other study ID #: LB4S
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: July 2022
• Source: Guangdong Provincial People's Hospital
• Contact: Wen-Zhao Zhong, Ph.D
• Phone: +86 02083827812
• Email: syzhongwenzhao[@]scut.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer
• Oligometastatic Disease

Intervention

Genetic:
• ctDNA testing and whole exome sequencing
Blood samples will be obtained for ctDNA testing and tumor tissue for whole exome sequencing.

Locations

Country	Name	City	State
China	Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Construction of a survival-prediction model	The survival-prediction model based on clinicopathological and genomic characteristics.	Through study completion, up to 5 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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