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Sitravatinib + Pembrolizumab for Non-Small Cell Lung Cancer
Study Summary
This trial is testing a new combination of drugs to treat non-squamous NSCLC that is positive for PD-L1.
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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- If you have an autoimmune disease that has been active in the past 2 years, you cannot participate. However, if you have specific autoimmune conditions like type 1 diabetes, vitiligo, Graves' disease, or hypothyroidism that only need hormone replacement, you can still participate.You have another type of cancer that could be confused with the cancer being studied.You have specific mutations in your genes called EGFR, ROS1, ALK, or BRAF.You have received treatment with drugs that boost the immune system before.Women who could become pregnant must have a negative pregnancy test before joining the study.You have a specific type of lung cancer that has spread to other parts of the body or cannot be removed with surgery.You have already been treated with a medication that works in a similar way as sitravatinib.You had a very serious blood clot in the past 6 months. If you had a less serious blood clot, you can still participate as long as you are getting standard treatment.You have had unstable chest pain or congestive heart failure in the past 6 months, or certain heart rhythm or pumping problems. Your high blood pressure is not well controlled despite treatment.Your HIV is not under control. You may still be able to join the study if you meet certain requirements.You have an ongoing hepatitis C infection, but if you have completed treatment and have no detectable virus and normal liver function, you may be eligible.You had a stroke or mini-stroke in the last 6 months.You have had significant coughing up of blood or bleeding within 4 weeks before the study starts.You have a disease that can be measured using specific guidelines.Your PD-L1 levels are at least 1%, as tested in a certified lab.You have a good level of physical ability, with minimal to no impact on your daily activities.You are expected to live for at least 3 more months.You have leptomeningeal disease.You have brain tumors that are causing symptoms or haven't been treated, except in certain situations where they're stable and don't require strong medications.You have not had any previous treatments for advanced disease, except for chemotherapy for local or locally advanced disease completed more than 6 months ago. You have not had any prior immunotherapy.You have a weakened immune system due to a medical condition or medication, except for certain types of steroids used in specific ways.Your blood counts, liver function, and kidney function must be at certain levels to join the study.
- Group 1: Group 1A: PD-L1 1-49%, Main Study Population
- Group 2: Group 1B: PD-L1 1-49%, Pembrolizumab run-in population
- Group 3: Group 2A: PD-L1 ≥ 50%, Main Study Population
- Group 4: Group 2B: PD-L1 ≥ 50%, Pembrolizumab run-in population
- 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
Are there any vacancies remaining in this research protocol?
"Affirmative. According to information accessible on clinicaltrials.gov, this experiment is actively recruiting patients and was initially shared on February 10th 2022 with its most recent update occurring October 26th of the same year. 70 research participants are required from 3 different sites."
How many individuals are currently participating in this clinical experiment?
"Affirmative, clinicaltrials.gov details that this medical study is actively looking to recruit patients since its first posting on February 10th 2022 and latest update on October 26th 2022. 70 individuals must be enrolled at 3 sites for the trial's completion."
Could you provide a summary of the research conducted on Pembrolizumab?
"Currently, there are 975 clinical trials exploring the efficacy of Pembrolizumab treatment. Of these studies, 124 have reached Phase 3 and many of them originate from Houston, Texas. However, there exists a global network with 36150 sites running research for this medication."
How is Pembrolizumab utilized to treat medical conditions?
"Pembrolizumab is typically used to battle malignant neoplasms, although it has also been known to be successful in treating unresectable melanoma, microsatellite instability high, or chemotherapy-resistant diseases."
Has Pembrolizumab been granted sanction by the FDA?
"Our Power team evaluated pembrolizumab's safety as a 2, owing to the fact that Phase 2 data only provide insight into its security profile and not its efficacy."
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