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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2030-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SBRT/Radiotherapy followed by standard of care therapy

Group Type EXPERIMENTAL

SBRT

Intervention Type RADIATION

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

No SBRT and switch to second-line standard of care therapy

Group Type ACTIVE_COMPARATOR

Second-line standard of care therapy

Intervention Type OTHER

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

Interventions

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SBRT

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

Intervention Type RADIATION

Second-line standard of care therapy

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

Intervention Type OTHER

Eligibility Criteria

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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 an actionable driver mutation, 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 second-line systemic therapy options if randomized to Arm 2.
* 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.
* 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.
* Patients who are not on actively on ICI or ICI + chemotherapy.
* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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C. Jillian Tsai

Role: STUDY_CHAIR

University Health Network Princess Margaret Hospital, Toronto, ON Canada

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2024-09093

Identifier Type: OTHER

Identifier Source: secondary_id

CCTG-BR38

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

SBRT/Radiotherapy followed by standard of care therapy

SBRT

No SBRT and switch to second-line standard of care therapy

Second-line standard of care therapy

Interventions

SBRT

Second-line standard of care therapy

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Canadian Cancer Trials Group

Alliance for Clinical Trials in Oncology

ECOG-ACRIN Cancer Research Group

NRG Oncology

SWOG Cancer Research Network

Responsible Party

Principal Investigators

C. Jillian Tsai

Locations

City of Hope Comprehensive Cancer Center

City of Hope at Irvine Lennar

Saint Mary's Hospital and Regional Medical Center

Saint Luke's Cancer Institute - Boise

Saint Luke's Cancer Institute - Fruitland

Saint Luke's Cancer Institute - Meridian

Saint Luke's Cancer Institute - Nampa

Alton Memorial Hospital

Northwestern University

Decatur Memorial Hospital

Crossroads Cancer Center

HSHS Saint Elizabeth's Hospital

Memorial Hospital East

Mercy Hospital

Oncology Associates at Mercy Medical Center

Saint Francis Medical Center

Siteman Cancer Center at Saint Peters Hospital

Siteman Cancer Center at West County Hospital

Washington University School of Medicine

Siteman Cancer Center-South County

Siteman Cancer Center at Christian Hospital

Nebraska Medicine-Bellevue

Nebraska Medicine-Village Pointe

University of Nebraska Medical Center

Mount Sinai Chelsea

Mount Sinai West

Mount Sinai Hospital

State University of New York Upstate Medical University

University of Oklahoma Health Sciences Center

Penn State Milton S Hershey Medical Center

Geisinger Medical Oncology-Lewisburg

Vanderbilt University/Ingram Cancer Center

Odette Cancer Centre- Sunnybrook Health Sciences Centre

University Health Network-Princess Margaret Hospital

Countries

Central Contacts

Pierre-Olivier Gaudreau

Facility Contacts

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