Pulse Radiotherapy to Overcome Metastatic Immune System Evasion in Lung Cancer

Launched by HOUDA BAHIG · Sep 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with advanced non-small cell lung cancer (NSCLC) that has not responded to standard immunotherapy. The researchers want to see if a special kind of radiotherapy, delivered in pulses, can safely work alongside immunotherapy to help the immune system fight the cancer better. The main focus is on ensuring that the treatment is safe for patients, while also looking at how well it helps control the cancer and improves the patients' quality of life. The study plans to include 32 participants.

To be eligible for this trial, participants must be at least 18 years old, currently receiving certain immunotherapy drugs, and show signs that their cancer is progressing. They should have several areas of cancer spread in their body and must be able to safely receive this new treatment. Patients with brain metastases can participate if they are treated according to standard care. However, individuals who are pregnant, have certain medical conditions, or a history of specific complications are not able to join. Those who participate can expect close monitoring throughout the study, and they will be contributing to important research that could lead to new options for lung cancer treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants must be ≥ 18 years old
• • Ability to provide written informed consent
• • Actively receiving PD(L)-1 inhibitors
• • Progressive disease defined as per RECIST criteria 1.1 on CT metrics as a greater than 20% increase in the sum measurement of lesions, non-target unequivocal progressive disease or a new lesion on CT.
• • Radiological progression to ≥ 5 disease sites. Progression at the primary tumor site should be counted within the total number of progressive lesions. For patients with lymph node metastases, each node is counted as one site of metastasis.
• • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• • Patients with brain metastasis are allowed and should be treated as per standard of care
• • All sites of disease can, in the opinion of the investigator, be safely treated and targetable with high-to-intermediate or low dose radiotherapy (taking into account prior local therapy, organ function and underlying medical condition such as inflammatory bowel disease, pulmonary fibrosis, etc.)
• • Patients with prior metastases that have been treated with ablative therapies (e.g. radiotherapy, surgery or radiofrequency ablation) before their current line of systemic therapy, are eligible.
• • Patients receiving additional systemic therapy agents such as chemotherapy are eligible, provided the other systemic agents are temporarily halted during radiation treatment.
• Exclusion Criteria:
• • Pregnant or breastfeeding individuals are excluded.
• • Medical conditions that would hinder the safe administration of radiotherapy or follow-up.
• • Patients who are ineligible for immunotherapy.
• • Patients with a history of pneumonitis are excluded.
• • Presence of an active autoimmune disease.