Pulse Radiotherapy with Immunotherapy for Lung Cancer That Stopped Responding
Tests pulsed radiation with immunotherapy in adults with lung cancer resistant to immune checkpoint inhibitors.
Plain-language title generated from the registry record
Registry title: Pulse Radiotherapy to Overcome Metastatic Immune System Evasion in Lung Cancer
Key facts
- Where
- Montreal, CanadaSee the site
- Phase
- Phase 1
Where in Canada
- Centre Hospitalier de l'Université de MontréalMontreal, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre hospitalier de l'Université de Montréal (CHUM)
- Trial code
- NCT06622174
- Record updated
- 24 August 2026
- Original description
This phase I study aims to evaluate the safety and effectiveness of adaptive pulsed radiotherapy combined with immunotherapy in patients with metastatic non-small cell lung cancer (NSCLC) resistant to immune checkpoint inhibitors. The primary goal is to assess treatment-related toxicity, while secondary objectives include progression-free survival, overall survival, and quality of life. The study will enroll 32 patients.Read full original descriptionShow less
Pulse Radiotherapy to Overcome Metastatic Immune System Evasion in Lung Cancer (PROMISE) - Phase I Trial
This phase I study aims to evaluate the safety and effectiveness of adaptive pulsed radiotherapy combined with immunotherapy in patients with metastatic non-small cell lung cancer (NSCLC) resistant to immune checkpoint inhibitors. The primary goal is to assess treatment-related toxicity, while secondary objectives include progression-free survival, overall survival, and quality of life. The study will enroll 32 patients.
Inclusion: 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: Patients who are ineligible for immunotherapy; Medical conditions that would hinder the safe administration of radiotherapy or follow-up; Patients with a history of pneumonitis are excluded; Presence of an active autoimmune disease; Pregnant or breastfeeding individuals are excluded.