Assessing liquid biopsy in patients with advanced lung cancer undergoing surgery

Liquid Biopsy in Advanced Oligometastatic NSCLC Receiving Surgery

This study is testing if a simple blood test can help doctors better understand and treat patients with advanced lung cancer who are having surgery.

Quick facts

• Study type: Observational
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Guangdong Provincial People's Hospital (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05648370 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the clinical feasibility of using circulating tumor DNA (ctDNA) through liquid biopsy in patients with oligometastatic non-small cell lung cancer (NSCLC) who are receiving surgical treatment. A total of 60 eligible patients will be enrolled, and dynamic blood samples will be collected before and after surgery, along with tissue samples for exploratory analysis. The study will focus on understanding the potential of ctDNA testing and whole exome sequencing in this patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old with oligometastatic NSCLC who are eligible for surgical treatment.

Not a fit: Patients with extensive metastatic disease or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the monitoring and management of oligometastatic NSCLC, potentially leading to improved patient outcomes.

How similar studies have performed: While the use of liquid biopsy in cancer monitoring is gaining traction, this specific approach in oligometastatic NSCLC is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

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;

Where this trial is running

Guangzhou, Guangdong

• Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Wen-Zhao Zhong, Ph.D — Guangdong Provincial People's Hospital
• Study coordinator: Wen-Zhao Zhong, Ph.D

Conditions Non-small Cell Lung Cancer; Oligometastatic Disease