Testing the Addition of an Antibody to Standard Chemoradiation Followed by the Antibody for One Y… (NCT04092283) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Testing the Addition of an Antibody to Standard Chemoradiation Followed by the Antibody for One Year to Standard Chemoradiation Followed by One Year of the Antibody in Patients With Unresectable Stage III Non-Small Cell Lung Cancer
United States, Guam660 participantsStarted 2020-04-29
Plain-language summary
This phase III trial studies how well an antibody (durvalumab) with chemotherapy and radiation therapy (chemoradiation) works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This study is being done to see if adding durvalumab to standard chemoradiation followed by additional durvalumab can extend patients life and/or prevent the tumor from coming back compared to the usual approach of chemoradiation alone followed by durvalumab.
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:
* STEP 1 INCLUSION ELIGIBILITY CRITERIA - CONCURRENT THERAPY
* Patient must be \>= 18 years old
* Patient must have one of the following:
* Newly diagnosed stage IIIA/B/C non-small cell lung cancer (NSCLC) (per the American Joint Committee on Cancer \[AJCC\] 8th edition) that is unresectable and is histologically and/or cytologically confirmed
* Nodal recurrence after surgery for early stage NSCLC
* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Patient must have a body weight \> 30 kg
* Patient must not have unintentional weight loss \> 10% within 30 days prior to registration
* Patient must have a baseline electrocardiography (ECG) obtained within 6 weeks prior to registration
* Patient must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. Baseline imaging assessments and measurements used to evaluate all measurable or non-measurable sites of disease must be done within 4 weeks prior to registration
* Absolute neutrophil count (ANC) \>= 1500 cells/uL (obtained =\< 7 days prior to registration)
* White blood cells (WBC) counts \>= 2500/uL (obtained =\< 7 days prior to registration)
* Platelet count \>= 100,000/uL (obtained =\< 7 days prior to registration)
* Hemoglobin \>= 9.0 g/dL (obtained =\< 7 days prior to registration)
* Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) with the following exception: patients with known Gilbert dise…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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 (OS)
Timeframe: From randomization to death from any cause, assessed up to 10 years