Clinical trial for Non Small Cell Lung Cancer
Official title Pulse Radiotherapy to Overcome Metastatic Immune System Evasion in Lung Cancer
ClinicalTrials.gov ID: NCT06622174
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Radiological progression to ≥ 5 disease sites. Progression at the primary tumor site should be counted within the total number of progressive...
You likely can't join if
- 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.
See the full eligibility 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...
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.