The Effect of Combined Cryotherapy and Immunotherapy on Systemic T Cell Changes and Clinical Outcomes in Metastatic Non-small Cell Lung Cancer
Lithuanian University of Health Sciences
120 participants
Apr 1, 2023
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
Inclusion Criteria6
- Patients with Eastern Cooperative Oncology Group (ECOG) performance score 0 - 1;
- Patients with histologically confirmed metastatic non-small cell lung cancer and PD-L1 expression on tumor cells was evaluated;
- CT examination shows measurable tumor formations according to the RECIST 1.1 criteria;
- Primary lung tumor or metastasis accessible to flexible bronchoscopy;
- Patients may have received surgery, adjuvant or neoadjuvant chemotherapy prior to the study if it was completed at least 12 months before relapse;
- Patients informed about the purpose and course of the study and provided a written consent to participate.
Exclusion Criteria11
- Patients who refused to participate in the clinical trial and did not sign the informed consent form;
- Men and women under the age of 18, pregnant women;
- Patients belonging to a vulnerable social group;
- High risk of general anesthesia, defined as American Society of Anesthesiologists (ASA) class 4 - 6;
- Documented allergy to medications used during general and local anesthesia, systemic cancer treatment;
- Patients previously treated with immune checkpoint inhibitors;
- EGFR mutations or ALK translocations have been identified in patients;
- Patients with previously diagnosed autoimmune diseases, active viral hepatitis, uncontrolled human immunodeficiency virus (HIV) infection or untreated tuberculosis;
- Patients treated with immunosuppressive drugs, systemic corticosteroids, with equivalent doses of prednisolone exceeding 10 mg/day;
- Patients with an increased risk of bleeding during an interventional procedure;
- Acute untreated conditions that would make it impossible to perform an interventional lung procedure.
Interventions
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.
As a standard of care, patients will receive pembrolizumab.
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)
View Full Details on ClinicalTrials.gov
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NCT06000358