Combining cryotherapy and immunotherapy for advanced lung cancer treatment

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

This study tests if using cryotherapy together with immunotherapy can help people with advanced lung cancer live longer and feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Lithuanian University of Health Sciences (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Kaunas)
• Trial ID: NCT06000358 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of combining cryotherapy with immunotherapy in patients with metastatic non-small cell lung cancer. The researchers hypothesize that cryotherapy can enhance the immune response triggered by immune checkpoint inhibitors, potentially leading to improved clinical outcomes. Eligible patients will receive bronchoscopic cryotherapy alongside pembrolizumab and platinum-based chemotherapy. The goal is to assess changes in systemic T cell activity and overall patient survival rates.

Who should consider this trial

Good fit: Ideal candidates include adults with stage IV non-small cell lung cancer who have a good performance status and measurable tumors.

Not a fit: Patients who are under 18, pregnant, or have a high risk of general anesthesia may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to better treatment outcomes and longer survival for patients with advanced lung cancer.

How similar studies have performed: While the combination of cryotherapy and immunotherapy is a novel approach, similar studies have shown promise in enhancing immune responses in cancer treatment.

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.

Where this trial is running

Kaunas

• Lithuanian University of Health Sciences — Kaunas, Lithuania (Recruiting)

Study contacts

• Study coordinator: Marius Zemaitis, PhD, professor

Conditions Lung Cancer Stage IV; Pulmonology; Oncology; Immunotherapy; Cryotherapy