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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Lithuania
Lithuanian University of Health Sciences
RECRUITING
Kaunas
Contact Information
Primary
Marius Zemaitis, PhD, professor
marius.zemaitis@kaunoklinikos.lt
+37061256473
Backup
Gediminas Vasiliauskas, PhD student
gediminas.vasiliauskas@kaunoklinikos.lt
+37060403787
Time Frame
Start Date: 2023-04-01
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 120
Treatments
Active_comparator: Cryotherapy and Pembrolizumab monotherapy;
Patients with metastatic non-small cell lung cancer, who are eligible for first-line pembrolizumab monotherapy (PD-L1 expression equal to or greater than 50%, no EGFR mutations or ALK translocations). Bronchoscopic cryotherapy procedure is performed before the start of systemic treatment.
Active_comparator: Cryotherapy and Pembrolizumab with platinum-based chemotherapy;
Patients with metastatic non-small cell lung cancer, who are eligible for first-line pembrolizumab and platinum-based chemotherapy (PD-L1 expression less than 50%, no EGFR mutations or ALK translocations). Bronchoscopic cryotherapy procedure is performed before the start of systemic treatment.
Active_comparator: Pembrolizumab monotherapy;
Patients with metastatic non-small cell lung cancer, who are eligible for first-line pembrolizumab monotherapy (PD-L1 expression equal to or greater than 50%, no EGFR mutations or ALK translocations).
Active_comparator: Pembrolizumab with platinum-based chemotherapy;
Patients with metastatic non-small cell lung cancer, who are eligible for first-line pembrolizumab and platinum-based chemotherapy (PD-L1 expression less than 50%, no EGFR mutations or ALK translocations).
Sponsors
Leads: Lithuanian University of Health Sciences
Collaborators: Research Council of Lithuania

This content was sourced from clinicaltrials.gov