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Trial Title:
The Effect of Combined Cryotherapy and Immunotherapy on Systemic T Cell Changes and Clinical Outcomes in Metastatic Non-small Cell Lung Cancer
NCT ID:
NCT06000358
Condition:
Lung Cancer Stage IV
Conditions: Official terms:
Lung Neoplasms
Pembrolizumab
Conditions: Keywords:
Pulmonology
Oncology
Immunotherapy
Cryotherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Bronchoscopic cryotherapy
Description:
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.
Arm group label:
Cryotherapy and Pembrolizumab monotherapy;
Arm group label:
Cryotherapy and Pembrolizumab with platinum-based chemotherapy;
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
As a standard of care, patients will receive pembrolizumab.
Arm group label:
Cryotherapy and Pembrolizumab monotherapy;
Arm group label:
Cryotherapy and Pembrolizumab with platinum-based chemotherapy;
Arm group label:
Pembrolizumab monotherapy;
Arm group label:
Pembrolizumab with platinum-based chemotherapy;
Intervention type:
Drug
Intervention name:
Platinum based chemotherapy
Description:
As a standard of care, patients will receive platinum-based chemotherapy in addition to
pembrolizumab if PD-L1 expression is less than 50%.
Arm group label:
Cryotherapy and Pembrolizumab with platinum-based chemotherapy;
Arm group label:
Pembrolizumab with platinum-based chemotherapy;
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Lithuanian University of Health Sciences
Address:
City:
Kaunas
Zip:
LT 44307
Country:
Lithuania
Status:
Recruiting
Contact:
Last name:
Rimantas Benetis, PhD, professor
Phone:
+37037327200
Email:
rektoratas@lsmuni.lt
Start date:
April 1, 2023
Completion date:
March 31, 2026
Lead sponsor:
Agency:
Lithuanian University of Health Sciences
Agency class:
Other
Collaborator:
Agency:
Research Council of Lithuania
Agency class:
Other
Source:
Lithuanian University of Health Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06000358
