RecruitingNot ApplicableNCT06000358

The Effect of Combined Cryotherapy and Immunotherapy on Systemic T Cell Changes and Clinical Outcomes in Metastatic Non-small Cell Lung Cancer


Sponsor

Lithuanian University of Health Sciences

Enrollment

120 participants

Start Date

Apr 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Lung cancer remains one of the most commonly diagnosed oncological diseases worldwide and the first in terms of mortality. Although immune checkpoint inhibitors form the backbone of current metastatic non-small cell lung cancer treatments, there is still no ideal predictive marker for its efficacy and patients still achieve suboptimal results in overall response and survival. While immune checkpoint inhibitors are known to shift systemic anti-tumor immune response from suppression to stimulation in some patients, the investigators hypothesize that this effect can be further enhanced by cryotherapy, especially in "cold" tumors. If proven successful, cryotherapy in combination with immunotherapy, could potentiate a more powerful immune response compared to systemic therapy alone, improve overall response rate, patients' survival without disease progression, and overall survival. The investigators, therefore, aim to use combined local tumor cryotherapy, combined with immune checkpoint inhibitor therapy to induce and evaluate systemic anti-tumor T lymphocyte response and achieve improved non-small cell lung cancer patient outcomes than with immunotherapy alone.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining cryotherapy (freezing tumor tissue to destroy it) with immunotherapy improves immune system responses and clinical outcomes in patients with metastatic non-small cell lung cancer (NSCLC). **You may be eligible if...** - You have been diagnosed with metastatic (spread) non-small cell lung cancer, confirmed by biopsy - Your overall health is good (ECOG performance score 0 or 1) - Your tumor has been evaluated for a protein called PD-L1 - Your tumor (or a metastasis) can be reached by bronchoscopy - If you had prior surgery or chemotherapy, it was completed at least 12 months before your current relapse **You may NOT be eligible if...** - You refused to participate or did not sign the consent form - You are under 18 years old - Your primary tumor cannot be accessed by bronchoscopy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBronchoscopic cryotherapy

The cryotherapy procedure is performed before the start of systemic treatment, under visual (for endobronchial cryotherapy) or radial EBUS and fluoroscopy control (for transbronchial cryotherapy), ensuring the correct position of the cryoprobe in the tumor. After being placed in the correct position. After being placed in the correct position, the cryoprobe is cooled using CO2 and allowed to cool passively. The cooling-thawing stages are repeated for a total of 3 cycles.

DRUGPembrolizumab

As a standard of care, patients will receive pembrolizumab.

DRUGPlatinum based chemotherapy

As a standard of care, patients will receive platinum-based chemotherapy in addition to pembrolizumab if PD-L1 expression is less than 50%.


Locations(1)

Lithuanian University of Health Sciences

Kaunas, Lithuania

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NCT06000358


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