RecruitingRecruiting
Radiotherapy to Block Oligoprogression In Metastatic Non-Small-Cell Lung Cancer
NCT06686771 · Canadian Cancer Trials Group
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Consolidative Use of Radiotherapy to Block (CURB2) Oligoprogression In Patients With Metastatic Non-Small-Cell Lung Cancer
About this study
The usual approach for patients who are not in a study and whose disease has gotten worse is to switch treatments. Sometimes, combinations of drugs or radiotherapy are used. The study doctor can explain which treatment may be best. These treatments can reduce symptoms and may stop the tumour from growing for several months or longer.
Eligibility criteria
Inclusion Criteria:
* Metastatic disease (stage IV) detected on imaging and histologically and/or cytologically confirmed NSCLC as per the WHO Classification of Tumors and AJCC 8th Edition TNM Classification, without a driver mutation with an actionable first-line targeted therapy, for whom either ICI alone or combination ICI + chemotherapy is indicated
* Oligoprogression on first-line ICI +/- chemotherapy systemic therapy after at least 3 cycles.
* All sites of oligoprogression can be safely treated with SBRT or ablative radiotherapy as determined by radiation treatment preplan, including availability and tolerability of necessary technologies (e.g., active breathing control, MRLinac, fiducial insertion, etc.) and accounting for previous radiotherapy overlap. Safety must be assessed and determined by a radiation oncologist.
* Patients with treated CNS disease who have radiologic and clinical evidence of stable brain metastases, with no evidence of cavitation or hemorrhage in the brain lesion, are eligible providing that they are asymptomatic and do not require corticosteroids (must have discontinued steroids at least 1 week prior to randomization).
* Candidate for regulatory approved SOC first-line orsecond-line systemic therapy options.
* Participants must be ≥ 18 years of age.
* ECOG performance status of 0, 1 or 2.
* Participants that received prior adjuvant/neoadjuvant/consolidation systemic therapy (including chemotherapy and ICI ) are eligible if at least 6 months have elapsed between the completion of prior therapy and start of first-line treatment for metastatic disease.
* Participants must have recovered to ≤ grade 1 from all reversible toxicity related to prior systemic therapy. If participants experienced prior immune-mediated toxicity and have not yet re-initiated ICI therapy, please contact CCTG. Please also contact CCTG if participants have ongoing toxicity ≥ grade 1 felt to be clinically insignificant.
* Previous surgery related to NSCLC in the curative or metastatic disease setting is permitted. Previous major surgery is permitted provided that surgery occurred at least 28 days prior to participant enrollment and that wound healing has occurred.
* Prior external beam radiation related to NSCLC in the metastatic disease setting is permitted provided a minimum of 14 days (2 weeks) have elapsed between the last dose of radiation and date of enrollment. Patients that received prior external beam radiation therapy in the NSCLC curative disease setting (including the primary lesion) are eligible. Oligoprogressive lesions previously treated with external beam radiation are eligible as long they are clinically asymptomatic, and re-treatment is possible according to the investigator.
* Prior conventional, non-stereotactic radiotherapy for palliative purposes is allowed, and if the palliated lesion subsequently progressed but asymptomatic not requiring immediate RT, the lesion can still be counted toward one of the five oligoprogressive lesions.
* For Arm 1, SBRT must be initiated within 3 weeks of participant enrollment.
* Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and/or health utility questionnaires in either English, French, or Spanish.
* Reimbursement of continued SOC ICI and chemotherapy systemic therapies may not be uniform across all sites. In the event that site/investigator is unable to provide access to the drug, participant will not be eligible for this trial.
* Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
* Participants of childbearing potential must have agreed to use a highly effective contraceptive method.
Exclusion Criteria:
* Large-cell neuroendocrine carcinoma (LCNEC), pulmonary carcinoid tumour or mixed small cell and non-small cell lung cancer are not eligible.
* Presence of leptomeningeal disease.
* Pregnancy.
* Serious medical conditions in which radiotherapy of target lesions is contraindicated (e.g., scleroderma, Ataxia Telangiectasia (ATM), interstitial lung disease (ILD), Child-Pugh C liver function).
* Any other condition in which in the judgement of the investigator would make the patient inappropriate for study entry.
* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
* Concomitant medications should only exclude participants from trial participation when clinically relevant known or predicted drug-drug interactions or potential overlapping toxicities will impact safety or efficacy; please consult the relevant product monographies.
* Concurrent treatment with other anti-cancer therapy, including investigational agents.
* Live attenuated vaccination administered within 30 days prior to enrollment/randomization.
Study design
Enrollment target: 320 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-12-16
Estimated completion: 2030-12-31
Last updated: 2026-07-14
Interventions
Radiation: SBRTOther: First or second-line standard of care therapy
Primary outcomes
- • Progression-free survival (5.5 years)
- • Overall survival (5.5 years)
Sponsor
Canadian Cancer Trials Group · network
With: Alliance for Clinical Trials in Oncology, ECOG-ACRIN Cancer Research Group, NRG Oncology, SWOG Cancer Research Network
Contacts & investigators
ContactPierre-Olivier Gaudreau · contact · p-ogaudreau@ctg.queensu.ca · 613-533-6430
InvestigatorC. Jillian Tsai · study_chair, University Health Network Princess Margaret Hospital, Toronto, ON Canada
All locations (75)
Mayo Clinic Hospital in ArizonaRecruiting
Phoenix, Arizona, United States
City of Hope Comprehensive Cancer CenterRecruiting
Duarte, California, United States
City of Hope at Irvine LennarRecruiting
Irvine, California, United States
Saint Mary's Hospital and Regional Medical CenterRecruiting
Grand Junction, Colorado, United States
CTCA at Southeastern Regional Medical CenterRecruiting
Newnan, Georgia, United States
Saint Luke's Cancer Institute - BoiseRecruiting
Boise, Idaho, United States
Saint Luke's Cancer Institute - FruitlandRecruiting
Fruitland, Idaho, United States
Saint Luke's Cancer Institute - MeridianRecruiting
Meridian, Idaho, United States
Saint Luke's Cancer Institute - NampaRecruiting
Nampa, Idaho, United States
Alton Memorial HospitalRecruiting
Alton, Illinois, United States
Northwestern UniversityRecruiting
Chicago, Illinois, United States
Decatur Memorial HospitalRecruiting
Decatur, Illinois, United States
Northwestern Medicine Cancer Center KishwaukeeRecruiting
DeKalb, Illinois, United States
Crossroads Cancer CenterRecruiting
Effingham, Illinois, United States
Northwestern Medicine Cancer Center DelnorRecruiting
Geneva, Illinois, United States
Northwestern Medicine Glenview Outpatient CenterRecruiting
Glenview, Illinois, United States
Northwestern Medicine Grayslake Outpatient CenterRecruiting
Grayslake, Illinois, United States
Northwestern Medicine Lake Forest HospitalRecruiting
Lake Forest, Illinois, United States
HSHS Saint Elizabeth's HospitalRecruiting
O'Fallon, Illinois, United States
Northwestern Medicine Oak BrookRecruiting
Oak Brook, Illinois, United States
Northwestern Medicine Orland ParkRecruiting
Orland Park, Illinois, United States
Memorial Hospital EastRecruiting
Shiloh, Illinois, United States
Northwestern Medicine Cancer Center WarrenvilleRecruiting
Warrenville, Illinois, United States
UI Health Care Mission Cancer and Blood - Ankeny ClinicRecruiting
Ankeny, Iowa, United States
Mercy HospitalRecruiting
Cedar Rapids, Iowa, United States
Oncology Associates at Mercy Medical CenterRecruiting
Cedar Rapids, Iowa, United States
UI Health Care Mission Cancer and Blood - West Des Moines ClinicRecruiting
Clive, Iowa, United States
Iowa Methodist Medical CenterRecruiting
Des Moines, Iowa, United States
UI Health Care Mission Cancer and Blood - Des Moines ClinicRecruiting
Des Moines, Iowa, United States
Mercy Medical Center - Des MoinesRecruiting
Des Moines, Iowa, United States
UI Health Care Mission Cancer and Blood - Laurel ClinicRecruiting
Des Moines, Iowa, United States
UI Healthcare Mission Cancer and Blood - PellaRecruiting
Pella, Iowa, United States
UI Health Care Mission Cancer and Blood - Waukee ClinicRecruiting
Waukee, Iowa, United States
Miller-Dwan HospitalRecruiting
Duluth, Minnesota, United States
Mayo Clinic in RochesterRecruiting
Rochester, Minnesota, United States
Coborn Cancer Center at Saint Cloud HospitalRecruiting
Saint Cloud, Minnesota, United States
Saint Francis Medical CenterRecruiting
Cape Girardeau, Missouri, United States
Siteman Cancer Center at Saint Peters HospitalRecruiting
City of Saint Peters, Missouri, United States
Siteman Cancer Center at West County HospitalRecruiting
Creve Coeur, Missouri, United States
Washington University School of MedicineRecruiting
St Louis, Missouri, United States
Siteman Cancer Center-South CountyRecruiting
St Louis, Missouri, United States
Siteman Cancer Center at Christian HospitalRecruiting
St Louis, Missouri, United States
Nebraska Medicine-BellevueRecruiting
Bellevue, Nebraska, United States
Nebraska Medicine-Village PointeRecruiting
Omaha, Nebraska, United States
University of Nebraska Medical CenterRecruiting
Omaha, Nebraska, United States
Northwell Health/Center for Advanced MedicineRecruiting
Lake Success, New York, United States
Mount Sinai ChelseaRecruiting
New York, New York, United States
Mount Sinai WestRecruiting
New York, New York, United States
Mount Sinai HospitalRecruiting
New York, New York, United States
Manhattan Eye Ear and Throat HospitalRecruiting
New York, New York, United States
Lenox Hill HospitalRecruiting
New York, New York, United States
Queens Cancer CenterRecruiting
Rego Park, New York, United States
University of RochesterRecruiting
Rochester, New York, United States
Stony Brook University Medical CenterRecruiting
Stony Brook, New York, United States
State University of New York Upstate Medical UniversityRecruiting
Syracuse, New York, United States
Montefiore Medical Center-Einstein CampusRecruiting
The Bronx, New York, United States
Montefiore Medical Center - Moses CampusRecruiting
The Bronx, New York, United States
Ohio State University Comprehensive Cancer CenterRecruiting
Columbus, Ohio, United States
University of Oklahoma Health Sciences CenterRecruiting
Oklahoma City, Oklahoma, United States
Geisinger Medical CenterRecruiting
Danville, Pennsylvania, United States
Penn State Milton S Hershey Medical CenterRecruiting
Hershey, Pennsylvania, United States
Geisinger Medical Oncology-LewisburgRecruiting
Lewisburg, Pennsylvania, United States
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer PavilionRecruiting
Mechanicsburg, Pennsylvania, United States
Thomas Jefferson University HospitalRecruiting
Philadelphia, Pennsylvania, United States
UPMC-Shadyside HospitalRecruiting
Pittsburgh, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer CenterRecruiting
Wilkes-Barre, Pennsylvania, United States
Vanderbilt University/Ingram Cancer CenterRecruiting
Nashville, Tennessee, United States
The Don and Sybil Harrington Cancer CenterRecruiting
Amarillo, Texas, United States
VCU Massey Cancer Center at Stony PointRecruiting
Richmond, Virginia, United States
VCU Massey Comprehensive Cancer CenterRecruiting
Richmond, Virginia, United States
Northwest Wisconsin Cancer CenterRecruiting
Ashland, Wisconsin, United States
Cross Cancer InstituteRecruiting
Edmonton, Alberta, Canada
CancerCare ManitobaRecruiting
Winnipeg, Manitoba, Canada
Odette Cancer Centre- Sunnybrook Health Sciences CentreRecruiting
Toronto, Ontario, Canada
University Health Network-Princess Margaret HospitalRecruiting
Toronto, Ontario, Canada