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New treatment option for Non-small Cell Lung Cancer
Official title Radiotherapy to Block Oligoprogression In Metastatic Non-Small-Cell Lung Cancer
ClinicalTrials.gov ID: NCT06686771
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Metastatic disease (stage IV) detected on imaging and histologically and/or cytologically confirmed NSCLC as per the WHO Classification of Tumors and...
- 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...
- Patients with treated CNS disease who have radiologic and clinical evidence of stable brain metastases, with no evidence of cavitation or hemorrhage...
- Candidate for regulatory approved SOC first-line orsecond-line systemic therapy options.
You likely can't join 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...
- 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 how...
See the full eligibility criteria
Who can join
- 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...
- 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 side effects of necessary technologies (e.g., active...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- Participants of childbearing potential must have agreed to use a highly effective contraceptive method.
What rules you out
- 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 how well it works assessment of the investigational regimen are eligible...
- 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 how well it...
- Concurrent treatment with other anti-cancer therapy, including investigational agents.
- Live attenuated vaccination administered within 30 days prior to enrollment/randomization.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Duarte, California, United States
- Irvine, California, United States
- Grand Junction, Colorado, United States
- Newnan, Georgia, United States
- Boise, Idaho, United States
- Fruitland, Idaho, United States
- Meridian, Idaho, United States
- Nampa, Idaho, United States
- Alton, Illinois, United States
- Chicago, Illinois, United States
- Decatur, Illinois, United States
- DeKalb, Illinois, United States
- Effingham, Illinois, United States
- Geneva, Illinois, United States
- Glenview, Illinois, United States
- Grayslake, Illinois, United States
- Lake Forest, Illinois, United States
- O'Fallon, Illinois, United States
- Oak Brook, Illinois, United States
+ 41 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Duarte, California, United States; Irvine, California, United States; Grand Junction, Colorado, United States; Newnan, Georgia, United States; Boise, Idaho, United States and 55 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.