NCT06622174RecruitingPhase 1
Pulse Radiotherapy to Overcome Metastatic Immune System Evasion in Lung Cancer
Pulse Radiotherapy to Overcome Metastatic Immune System Evasion in Lung Cancer (PROMISE) - Phase I Trial
Source: ClinicalTrials.gov · Last updated 24 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- First submitted
- 21 Sept 2024
- Start date
- 20 Aug 2026
- Primary completion date
- Jul 2028
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Diseases
- Lung cancer
- NCT number
- NCT06622174
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 32
- From 20 Aug 2026 to the primary completion date, Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who are ineligible for immunotherapy.
Other illness
- 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.
Other
- Pregnant or breastfeeding individuals are excluded.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier de l'Université de Montréal Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.