Testing the Addition of the Drug Atezolizumab to the Usual Radiation Treatment for Patients With … (NCT04214262) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Testing the Addition of the Drug Atezolizumab to the Usual Radiation Treatment for Patients With Early Non-small Cell Lung Cancer
United States415 participantsStarted 2020-08-13
Plain-language summary
This phase III trial studies how well atezolizumab added to the usual radiation therapy works in treating patients with stage I-IIA non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy, such as stereotactic body radiation therapy, uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving atezolizumab and radiation therapy may work better than radiation therapy alone in treating patients with early non-small cell lung cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient must have histologically or cytologically proven stage I-IIA or limited T3N0M0 non-small cell lung cancer (NSCLC), without radiographic evidence of nodal or distant involvement (N0M0). Patient may have T3 disease with the exclusion of pericardial involvement. Patients with multifocal tumors with no more than two lesions confirmed or suspected to be synchronous early stage NSCLCs are eligible provided at least one lesion is histologically or cytologically proven to be NSCLC and meets one or more high-risk features
* Disease must have one or more of the following high-risk features:
* Tumor diameter \>= 2 cm (inclusive of any non-solid, ground glass component) as assessed by diagnostic CT
* Tumor standard uptake value (SUV) max \>= 6.2 as assessed by FDG PET/CT
* Moderately differentiated, poorly differentiated, or undifferentiated histology
* Patient must have undergone diagnostic chest CT with or without contrast (IV contrast preferred) within 42 days prior to randomization. PET-CT may be used if the CT portion is of comparable diagnostic quality to a stand-alone CT. All disease must be assessed within 42 days prior to randomization
* Patient must have undergone FDG PET/CT of chest within 90 days prior to randomization
* Patient must not have evidence of hilar or mediastinal nodal involvement. Any patient with radiographically suspicious hilar or mediastinal nodes (including features such as non-calcified nodes with a short axis diameter …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial adds atezolizumab, an immunotherapy drug, to standard radiation for early-stage non-small cell lung cancer — can you walk me through what the known side effects of combining these two treatments look like, and how that compares to radiation alone?
2Since this is a Phase 3 trial measuring overall survival as its main goal, does that mean there's still uncertainty about whether adding atezolizumab actually helps people live longer, and what does the evidence look like so far?
3The trial is no longer enrolling new patients — does that affect my options in any way, and are there similar trials or approaches involving immunotherapy for early-stage lung cancer that I should know about?
4Given that this trial is for Stage I and Stage II non-small cell lung cancer, would my specific stage and tumor characteristics even make me a good candidate to discuss this kind of approach, and is standard radiation alone still considered effective for someone in my situation?
5For people with early-stage non-small cell lung cancer like mine, how does adding immunotherapy to radiation compare to surgery as a treatment path, and is one option generally preferred over the other at this stage?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall survival
Timeframe: From date of randomization to date of death due to any cause, assessed up to 3 years