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Neoadjuvant Immunoradiation for Lung Cancer
Study Summary
This trial is testing a new cancer treatment that combines immunotherapy and radiation. If it is safe, they will test it on more patients.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I haven't taken any experimental drugs within the last 28 days or 5 half-lives.I have not had major surgery within the last 28 days.I have received an organ transplant from another person.I have or had an autoimmune or inflammatory disorder.People with lasting side effects that won't get worse because of the study drug might still be able to join. For example, if you have hearing loss or peripheral neuropathy.I have not received a live vaccine within the last 30 days.I am not pregnant, breastfeeding, or if capable of having children, I am using effective birth control.You are expected to live for more than 6 months.You weigh more than 30 kilograms.My lung cancer can be removed with surgery according to my thoracic surgeon.I am fully active or can carry out light work.My blood tests for bone marrow and organ function are normal.I am post-menopausal or not currently pregnant.I have had lung inflammation treated with steroids or have ongoing lung inflammation.I do not have any serious ongoing illnesses that could interfere with the study.I do not have active infections like TB, hepatitis B, C, or HIV.I do not have another cancer that needs treatment now or soon.I don't have severe side effects from past cancer treatments.I am not on cancer treatment but may be on hormone therapy for other reasons.I haven't had extensive radiation to my bone marrow or wide field radiation in the last 4 weeks.I haven't taken immunosuppressive drugs in the last 14 days.My condition is stage III non-small cell lung cancer.I am 18 years old or older.I have had radiation therapy to my chest before.A thoracic surgeon has determined I need a pneumonectomy.I have previously been treated with specific immune therapies or cancer vaccines.
- Group 1: Durvalumab and Trememlimumab with Radiation
- Group 2: Durvalumab with Radiation
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many participants have enlisted in this research project?
"At this juncture, no further recruitment is being sought for this trial that was initially posted on December 12th 2017 and last updated November 8th 2022. Nonetheless, there are currently 2045 clinical trials searching for patients with non-small cell lung carcinoma (NSCLC) and 340 studies actively seeking participants to receive Thoracic Radiation."
Is this research endeavor seeking out participants aged 40 or beyond?
"According to the specified requirements, individuals aged 18-100 are eligible for this particular clinical trial. 55 studies permit applicants under 18 years old and 2377 trials accept people over 65."
Is this the inaugural trial of its kind?
"Currently, there are 340 active trials for Thoracic Radiation being conducted in 1327 cities and 58 countries. The first of these studies was sponsored by AstraZeneca and commenced back in 2007 with 37 participants taking part. In the intervening years, 123 investigations have been successfully concluded."
Has Thoracic Radiation earned the Food and Drug Administration's authorization?
"Given the Phase 2 clinical trial, which has yielded some evidence on safety but no data regarding efficacy, our team at Power assessed Thoracic Radiation to be a score of 2."
Which patient demographics are most suited to this trial?
"To qualify for enrollment, applicants must have been diagnosed with non-small cell lung carcinoma and fall within the age range of 18 to 100. A total of 9 patients are being accepted into this trial."
In what scenarios is Thoracic Radiation usually prescribed?
"Thoracic Radiation is often used to treat the progression of Stage III Non-Small cell lung cancer, as well as Metastatic Urothelial Carcinoma and Advance Directives."
Are there any opportunities for individuals to become participants in this experiment?
"As evidenced by clinicaltrials.gov, this medical trial is not recruiting at the present moment; it was initially posted on December 12th 2017 and last modified on November 8th 2022. However, there are an abundance of other trials actively enrolling patients today with a total of 2385 studies available to join."
What are the main goals of this experiment?
"The primary focus of this trial, assessed over a maximum period of 100 days is to determine the practicality of preoperative immunoradiation. Secondary objectives include measuring duration of response with recurrence-free survival by log-rank test and Cox proportional hazards (PH) model., evaluating surgical morbidity & mortality through log-rank test and Cox proportional hazards (PH) model., and assessing overall survival in terms of months alive after preoperative immunoradiation followed by surgery also via log-rank test and Cox proportional hazards (PH) model.."
What prior experiments have been conducted that involve Thoracic Radiation?
"Presently, 340 live clinical studies are researching Thoracic Radiation with 52 of these trials in Phase 3. Of the 13098 sites conducting this research, most are located in Cordoba, Texas."
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