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Radiation Therapy
SABR for Lung Cancer (SUPPRESS-NSCLC Trial)
Phase 2
Recruiting
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Oligoprogression while on ICI or TKI (any line)
Metastatic NSCLC enrolled in our CRCHUM Lung Cancer Registry and co-enrolled to the PERa registry
Must not have
Presence of spinal cord compression Metastatic disease that invades the GI tract (including esophagus, stomach, small or large bowel)
Any lesion beyond 5 cm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether a new cancer treatment is better than the current standard of care.
Who is the study for?
This trial is for adults with metastatic non-small cell lung cancer who have limited progression in up to 5 body sites while on current cancer drugs. They must be able to consent, have a performance status of 0-3, and not be pregnant or breastfeeding. Lesions must be smaller than 5 cm and not involve the GI tract.
What is being tested?
The study compares standard care options versus adding stereotactic ablative radiotherapy (SABR) to existing systemic therapy for patients whose lung cancer has progressed but remains limited. Patients are randomly assigned to either continue/change their current treatment or receive SABR alongside it.
What are the potential side effects?
Potential side effects from SABR may include skin reactions, fatigue, shortness of breath, chest pain, and inflammation around treated areas. The severity can vary based on individual health conditions and previous treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has spread in a limited way while on immunotherapy or targeted therapy.
Select...
I am registered in the CRCHUM Lung Cancer and PERa registries with metastatic NSCLC.
Select...
I am 18 years old or older.
Select...
I can care for myself but may not be able to do heavy physical work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My cancer has spread to my spine or digestive system.
Select...
I have a tumor larger than 5 cm.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
OS
PFS
Secondary study objectives
Grade ≥ 3 toxicity
Local control
Quality of life 5-level EQ-5D (EQ-5D-5L)
+2 moreSide effects data
From 2007 Phase 4 trial • 552 Patients • NCT001108907%
Diarrhoea
7%
Vomiting
3%
Nausea
3%
Nasopharyngitis
3%
Muscle spasms
1%
Angina pectoris
1%
Myocardial infarction
1%
Pericarditis
1%
Chest discomfort
1%
Hernia
1%
Jaundice
1%
Gastroenteritis
1%
Arteriovenous fistula thrombosis
1%
Joint dislocation
1%
Joint injury
1%
Shunt occlusion
1%
Shunt thrombosis
1%
Blood potassium increased
1%
Fluid retention
1%
Hypovolaemia
1%
Pancreatic carcinoma
1%
Cognitive disorder
1%
Skin ulcer
1%
Catheter placement
1%
Hypertensive crisis
1%
Arteriovenous fistula occlusion
1%
Orthostatic hypotension
1%
Cardiac arrest
1%
Chest pain
1%
Pyrexia
1%
Cholecystitis
1%
Arthritis bacterial
1%
Bacterial sepsis
1%
Fall
1%
Back pain
1%
Pain in extremity
1%
Dyspnoea
1%
Nephrectomy
1%
Hypotension
1%
Peripheral ischaemia
1%
Atrial flutter
1%
Cardiac asthma
1%
Abdominal pain
1%
Sudden cardiac death
1%
Transplant rejection
1%
Perianal abscess
1%
Pneumonia
1%
Urinary tract infection
1%
Ankle fracture
1%
Arteriovenous fistula site complication
1%
Rib fracture
1%
Cerebral infarction
1%
Gastrointestinal haemorrhage
1%
Catheter related infection
1%
Atrial fibrillation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard Care
Cinacalcet
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental SABR armExperimental Treatment1 Intervention
Definitive SABR to oligoprogressive lesions + continue current systemic therapy
Group II: Standard of careActive Control1 Intervention
Switch to subsequent systemic therapy line, best supportive care or continue current systemic line
Find a Location
Who is running the clinical trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
377 Previous Clinical Trials
131,452 Total Patients Enrolled
Houda Bahig, MD PhDStudy ChairCentre hospitalier de l'Université de Montréal (CHUM)
1 Previous Clinical Trials
106 Total Patients Enrolled
Bertrand Routy, MD PhDStudy ChairCentre hospitalier de l'Université de Montréal (CHUM)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to my spine or digestive system.My cancer has spread to 1-5 spots outside the brain, affecting up to 3 organs, and is under 5cm.My cancer has spread in a limited way while on immunotherapy or targeted therapy.I had treatments like radiation or surgery for cancer spread before my current treatment.I am registered in the CRCHUM Lung Cancer and PERa registries with metastatic NSCLC.My cancer can be safely targeted with SABR according to my doctor.I have brain metastasis but it's being treated according to standard care.I am 18 years old or older.I can care for myself but may not be able to do heavy physical work.I have a tumor larger than 5 cm.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of care
- Group 2: Experimental SABR arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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