Radiotherapy to Block Oligoprogression In Metastatic Non-Small-Cell Lung Cancer

NCT06686771 | Recruiting Phase 3 DMC FDA Device

• 2 other identifiers: CCTG-BR38NCI-2024-09093
• Study Type: interventional
• Target: 320
• Locations: 2 countries
• Sites: 74

Brief Summary

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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Progression-free survival

  5.5 years

• Overall survival

  5.5 years

Secondary Outcomes (5)

• Number and severity of adverse events

  5.5 years

• Patient-reported adverse events utilizing PRO-CTCAE questionnaire

  5.5 years

• Patient-reported quality of life utilizing EORTC-QLQ-C30 questionnaire

  5.5 years

• Patient-reported quality of life utilizing QLQ-LC-13 questionnaire

  5.5 years

• Cost-effectiveness utilizing EQ-5D-5L questionnaire (Canadian sites only)

  5.5 years

Study Arms (2)

SBRT/Radiotherapy followed by standard of care therapy

EXPERIMENTAL

Radiation: SBRT

Systemic therapy at the investigator's discretion, no SBRT

ACTIVE COMPARATOR

Other: First or second-line standard of care therapy

Interventions

SBRT RADIATION

Please refer to the current NCCN NSCLC guidelines for possible treatment options

SBRT/Radiotherapy followed by standard of care therapy

First or second-line standard of care therapy OTHER

Please refer to the current NCCN NSCLC guidelines for possible treatment options.

Systemic therapy at the investigator's discretion, no SBRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: collaborator
• ECOG-ACRIN Cancer Research Group: collaborator
• Canadian Cancer Trials Group: lead
• SWOG Cancer Research Network: collaborator
• NRG Oncology: collaborator

Study Sites (74)

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, 85054, United States

RECRUITING

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

RECRUITING

City of Hope at Irvine Lennar

Irvine, California, 92618, United States

RECRUITING

Saint Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, 81501, United States

RECRUITING

Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712, United States

RECRUITING

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, 83619, United States

RECRUITING

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, 83642, United States

RECRUITING

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, 83687, United States

RECRUITING

Alton Memorial Hospital

Alton, Illinois, 62002, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

RECRUITING

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, 60115, United States

RECRUITING

Crossroads Cancer Center

Effingham, Illinois, 62401, United States

RECRUITING

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, 60134, United States

RECRUITING

Northwestern Medicine Glenview Outpatient Center

Glenview, Illinois, 60026, United States

RECRUITING

Northwestern Medicine Grayslake Outpatient Center

Grayslake, Illinois, 60030, United States

RECRUITING

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, 60045, United States

RECRUITING

HSHS Saint Elizabeth's Hospital

O'Fallon, Illinois, 62269, United States

RECRUITING

Northwestern Medicine Oak Brook

Oak Brook, Illinois, 60523, United States

RECRUITING

Northwestern Medicine Orland Park

Orland Park, Illinois, 60462, United States

RECRUITING

Memorial Hospital East

Shiloh, Illinois, 62269, United States

RECRUITING

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555, United States

RECRUITING

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, 50023, United States

RECRUITING

Mercy Hospital

Cedar Rapids, Iowa, 52403, United States

RECRUITING

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, 52403, United States

RECRUITING

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Clive, Iowa, 50325, United States

RECRUITING

Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

RECRUITING

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, 50309, United States

RECRUITING

Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314, United States

RECRUITING

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, 50314, United States

RECRUITING

UI Healthcare Mission Cancer and Blood - Pella

Pella, Iowa, 50219, United States

RECRUITING

UI Health Care Mission Cancer and Blood - Waukee Clinic

Waukee, Iowa, 50263, United States

RECRUITING

Miller-Dwan Hospital

Duluth, Minnesota, 55805, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Coborn Cancer Center at Saint Cloud Hospital

Saint Cloud, Minnesota, 56303, United States

RECRUITING

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703, United States

RECRUITING

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, 63376, United States

RECRUITING

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, 63141, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Siteman Cancer Center-South County

St Louis, Missouri, 63129, United States

RECRUITING

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, 63136, United States

RECRUITING

Nebraska Medicine-Bellevue

Bellevue, Nebraska, 68123, United States

RECRUITING

Nebraska Medicine-Village Pointe

Omaha, Nebraska, 68118, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

Northwell Health/Center for Advanced Medicine

Lake Success, New York, 11042, United States

RECRUITING

Mount Sinai Chelsea

New York, New York, 10011, United States

RECRUITING

Mount Sinai West

New York, New York, 10019, United States

RECRUITING

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

Manhattan Eye Ear and Throat Hospital

New York, New York, 10065, United States

RECRUITING

Lenox Hill Hospital

New York, New York, 10075, United States

RECRUITING

Queens Cancer Center

Rego Park, New York, 11374, United States

RECRUITING

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

RECRUITING

State University of New York Upstate Medical University

Syracuse, New York, 13210, United States

RECRUITING

Montefiore Medical Center-Einstein Campus

The Bronx, New York, 10461, United States

RECRUITING

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467, United States

RECRUITING

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

RECRUITING

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

RECRUITING

Geisinger Medical Oncology-Lewisburg

Lewisburg, Pennsylvania, 17837, United States

RECRUITING

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

Mechanicsburg, Pennsylvania, 17050, United States

RECRUITING

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

UPMC-Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, 18711, United States

RECRUITING

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States

RECRUITING

The Don and Sybil Harrington Cancer Center

Amarillo, Texas, 79106, United States

RECRUITING

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, 23235, United States

RECRUITING

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, 23298, United States

RECRUITING

Northwest Wisconsin Cancer Center

Ashland, Wisconsin, 54806, United States

RECRUITING

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

RECRUITING

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

RECRUITING

Odette Cancer Centre- Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

University Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• C. Jillian Tsai

  University Health Network Princess Margaret Hospital, Toronto, ON Canada

  STUDY CHAIR

Central Study Contacts

Pierre-Olivier Gaudreau

CONTACT

613-533-6430; p-ogaudreau@ctg.queensu.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 13, 2024
• Study Start: December 16, 2025
• Primary Completion (Estimated): February 28, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: June 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (70); CA (4)