Radiotherapy to Block Oligoprogression In Metastatic Non-Small-Cell Lung Cancer
Purpose
This study is being done to answer the following question: Can the chance of lung cancer growing or spreading be lowered by adding targeted radiotherapy to the usual combination of drugs? This study is being done to find out if this approach is better or worse than the usual approach for lung cancer. The usual approach is defined as the care most people get for non-small cell lung cancer.
Condition
- Non-small Cell Lung Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental SBRT/Radiotherapy followed by standard of care therapy |
|
|
|
Active Comparator Systemic therapy at the investigator's discretion, no SBRT |
|
Recruiting Locations
City of Hope Comprehensive Cancer Center
Duarte, California 91010
Duarte, California 91010
City of Hope at Irvine Lennar
Irvine, California 92618
Irvine, California 92618
Contact:
Site Public Contact
877-467-3411
Site Public Contact
877-467-3411
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado 81501
Grand Junction, Colorado 81501
Saint Luke's Cancer Institute - Boise
Boise, Idaho 83712
Boise, Idaho 83712
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho 83619
Fruitland, Idaho 83619
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho 83642
Meridian, Idaho 83642
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho 83687
Nampa, Idaho 83687
Alton Memorial Hospital
Alton, Illinois 62002
Alton, Illinois 62002
Contact:
Site Public Contact
618-463-7323
Site Public Contact
618-463-7323
Northwestern University
Chicago, Illinois 60611
Chicago, Illinois 60611
Decatur Memorial Hospital
Decatur, Illinois 62526
Decatur, Illinois 62526
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois 60115
DeKalb, Illinois 60115
Crossroads Cancer Center
Effingham, Illinois 62401
Effingham, Illinois 62401
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois 60134
Geneva, Illinois 60134
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois 60026
Glenview, Illinois 60026
Contact:
Site Public Contact
312-695-1102
Site Public Contact
312-695-1102
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois 60030
Grayslake, Illinois 60030
Contact:
Site Public Contact
312-695-1102
Site Public Contact
312-695-1102
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois 60045
Lake Forest, Illinois 60045
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois 62269
O'Fallon, Illinois 62269
Northwestern Medicine Oak Brook
Oak Brook, Illinois 60523
Oak Brook, Illinois 60523
Northwestern Medicine Orland Park
Orland Park, Illinois 60462
Orland Park, Illinois 60462
Memorial Hospital East
Shiloh, Illinois 62269
Shiloh, Illinois 62269
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
Warrenville, Illinois 60555
Mercy Hospital
Cedar Rapids, Iowa 52403
Cedar Rapids, Iowa 52403
Contact:
Site Public Contact
319-365-4673
Site Public Contact
319-365-4673
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa 52403
Cedar Rapids, Iowa 52403
Contact:
Site Public Contact
319-363-2690
Site Public Contact
319-363-2690
Miller-Dwan Hospital
Duluth, Minnesota 55805
Duluth, Minnesota 55805
Saint Francis Medical Center
Cape Girardeau, Missouri 63703
Cape Girardeau, Missouri 63703
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri 63376
City of Saint Peters, Missouri 63376
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri 63141
Creve Coeur, Missouri 63141
Washington University School of Medicine
St Louis, Missouri 63110
St Louis, Missouri 63110
Siteman Cancer Center-South County
St Louis, Missouri 63129
St Louis, Missouri 63129
Siteman Cancer Center at Christian Hospital
St Louis, Missouri 63136
St Louis, Missouri 63136
Nebraska Medicine-Bellevue
Bellevue, Nebraska 68123
Bellevue, Nebraska 68123
Nebraska Medicine-Village Pointe
Omaha, Nebraska 68118
Omaha, Nebraska 68118
Contact:
Site Public Contact
402-559-5600
Site Public Contact
402-559-5600
University of Nebraska Medical Center
Omaha, Nebraska 68198
Omaha, Nebraska 68198
Mount Sinai Chelsea
New York, New York 10011
New York, New York 10011
Mount Sinai Hospital
New York, New York 10029
New York, New York 10029
State University of New York Upstate Medical University
Syracuse, New York 13210
Syracuse, New York 13210
Contact:
Site Public Contact
315-464-5476
Site Public Contact
315-464-5476
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
Geisinger Medical Center
Danville, Pennsylvania 17822
Danville, Pennsylvania 17822
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania 17033-0850
Hershey, Pennsylvania 17033-0850
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania 17837
Lewisburg, Pennsylvania 17837
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania 18711
Wilkes-Barre, Pennsylvania 18711
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee 37232
Nashville, Tennessee 37232
Contact:
Site Public Contact
800-811-8480
Site Public Contact
800-811-8480
VCU Massey Cancer Center at Stony Point
Richmond, Virginia 23235
Richmond, Virginia 23235
VCU Massey Comprehensive Cancer Center
Richmond, Virginia 23298
Richmond, Virginia 23298
Northwest Wisconsin Cancer Center
Ashland, Wisconsin 54806
Ashland, Wisconsin 54806
More Details
- Status
- Recruiting
- Sponsor
- Canadian Cancer Trials Group
Detailed Description
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.