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Adaptive Radiation + Pembrolizumab for Lung Cancer
Study Summary
This trial is testing a new way to give radiation therapy for stage IV lung cancer that may be more effective than the standard treatment.
Timeline
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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- My lung cancer is of a mixed small cell type.My organs are healthy enough for treatment, as confirmed by my doctors.I have had an organ transplant and take medication to suppress my immune system.I am able to get out of my bed or chair and move around.I have received more than one cycle of immunotherapy for my current cancer.I need whole brain radiotherapy for brain metastases.I haven't been hospitalized for lung problems in the last 30 days.I have not received a live vaccine in the last 30 days.I have not taken any prohibited medications in the last 30 days.I am not pregnant or breastfeeding.I have recent (less than 6 months old) tumor samples for PD-L1 testing.I haven't had major surgery in the last 4 weeks.My doctor thinks I am a good candidate for immunotherapy.I am 18 years old or older.I've had radiotherapy that now limits further treatment due to risk to healthy organs.I am using a reliable birth control method during the study.I haven't had any cancer except skin cancer or localized cancer that hasn't spread in the last 3 years.I have been treated for an autoimmune disease in the last year.I haven't taken immunosuppressive drugs in the last 28 days, except for allowed exceptions.I have fluid buildup due to cancer in my abdomen or chest.My brain metastases can be treated with surgery or targeted radiation before starting chemo-immunotherapy.I do not have HIV, hepatitis B or C, or active tuberculosis.My doctor thinks another systemic therapy could work for me.I do not have severe heart issues, uncontrolled blood pressure, severe chest pain, irregular heartbeat, active stomach ulcers, bleeding disorders, or mental health conditions that would limit my participation.My lung cancer is at an advanced stage and can be measured for treatment response.
- Group 1: Option B (carboplatin, paclitaxel, pembrolizumab, radiation)
- Group 2: Option C (pembrolizumab, radiation)
- Group 3: Option A (carboplatin, pemetrexed, pembrolizumab, radiation)
- Group 4: Option D (ipilimumab, nivolumab, 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
What goals are researchers trying to accomplish with this investigation?
"According to the sponsor, Varian Medical Systems, this clinical trial will assess a primary outcome of potential adverse events within 6 months. Additionally, secondary results will be evaluated such as quantitative and qualitative markers of treatment resource utilization when leveraging Ethos for radiation therapy (RT), progression-free survival estimated by Cox proportional hazards model with 95% confidence intervals (CI) presented by group, and overall survival also assessed using the same aforementioned methods."
Is this research accepting new participants?
"Clinicaltrials.gov states that this medical trial is not actively soliciting participants at the moment, despite having been first posted on January 31st 2023 and last updated October 19th 2022. However, there are 2,045 other studies recruiting right now."
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