What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies, chemotherapy, and radiation therapy. Targeted therapies, such as EGFR-TKIs, can cause side effects like diarrhea, rashes, anorexia, and anemia. Chemotherapy often leads to nausea, vomiting, fatigue, and increased risk of infection. Radiation therapy can result in skin irritation, fatigue, and difficulty swallowing. Procedures like EBUS-TFNA or EUS-FNA used for lymph node sampling are generally safe but can occasionally cause bleeding, infection, or pneumothorax.

What prior FDA approvals exist?

FDA approvals for the treatment of Non-Small Cell Lung Cancer (NSCLC) include several targeted therapies and immunotherapies. For instance, pembrolizumab combined with chemotherapy has been approved for first-line treatment of metastatic nonsquamous NSCLC, as demonstrated in the KEYNOTE-189 trial. Additionally, the combination of atezolizumab, bevacizumab, and chemotherapy (ABCP) has shown improved progression-free survival and overall survival in the IMpower 150 trial for advanced nonsquamous NSCLC. These treatments align with the focus on advanced NSCLC and the importance of accurate nodal assessment through procedures like EBUS-TFNA or EUS-FNA.

What other types of research exist?

Promising novel alternatives to lymph node sampling for NSCLC patients include advanced imaging techniques such as PET/CT and MRI, which can provide detailed information on nodal involvement. Additionally, liquid biopsy, which analyzes circulating tumor DNA (ctDNA) in the blood, is emerging as a non-invasive method to detect metastatic disease and monitor treatment response. These methods offer the potential for accurate assessment of nodal disease with less invasiveness compared to traditional sampling techniques.

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Lymph Node Sampling for Lung Cancer

N/A

Recruiting

Led By Inderdeep Dhaliwal, MD

Research Sponsored by Lawson Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a needle guided by ultrasound to sample lymph nodes and precise high-dose radiation to treat patients with advanced lung cancer. It aims to see if sampling lymph nodes gives better information about cancer spread compared to imaging tests alone.

Who is the study for?

This trial is for adults over 18 with Non-Small Cell Lung Cancer (NSCLC) who have undergone recent staging investigations. It's aimed at those with a good performance status, up to 5 metastases, and plans for radical treatment of all cancer sites. Pregnant women, individuals unable to consent, or those with contraindications to EBUS/EUS or chest radiotherapy cannot participate.

What is being tested?

The study tests if sampling lymph nodes using EBUS-TFNA or EUS-FNA can better determine the extent of nodal disease in NSCLC compared to imaging alone. Participants will also receive Stereotactic Ablative Radiotherapy (SABR), a precise high-dose radiation therapy.

What are the potential side effects?

Potential side effects from the procedures may include discomfort at the biopsy site, bleeding, infection risk from needle aspiration and general risks associated with anesthesia. SABR may cause skin irritation, fatigue, shortness of breath and other localized symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes to treatment intent and/or plan

Secondary study objectives

Determine the proportion of patients with complications of endoscopic procedure

Determine the proportion of patients with occult mediastinal metastasis

Determine the sensitivity and specificity of radiologic staging of hilar/mediastinal lymph nodes

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment ArmExperimental Treatment2 Interventions

Small pieces of suspicious chest lymph nodes will be removed with a procedure called endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TFNA) or transesophageal ultrasound-guided fine needle aspiration (EUS-FNA).

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies, chemotherapy, and radiation therapy. Targeted therapies inhibit specific molecular pathways, such as EGFR or ALK mutations, that drive cancer growth. Chemotherapy works by killing rapidly dividing cells, including cancer cells, through interference with cell division. Radiation therapy uses high-energy rays to destroy cancer cells by damaging their DNA. Accurate lymph node sampling using EBUS-TFNA or EUS-FNA is essential for precise staging and molecular diagnosis, which helps in selecting the most effective targeted therapies and treatment plans for NSCLC patients.

Accuracy of endoscopic ultrasound-guided needle aspiration specimens for molecular diagnosis of non-small-cell lung carcinoma.