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Osimertinib + Navitoclax for Lung Cancer
Study Summary
This trial studies the side effects and best dose of osimertinib and navitoclax when given together to treat patients with EGFR-positive non-small cell lung cancer.
- Non-Small Cell Lung Carcinoma
- Lung Cancer
- Non-Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria
You will 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.Side effects data
From 2020 Phase 4 trial • 60 Patients • NCT03853551Awards & Highlights
Trial Design
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Who is running the clinical trial?
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- You have been tested positive for specific mutations in your EGFR gene, which can activate cancer cells.You have a tumor that can be measured by a standard method called Response Evaluation Criteria in Solid Tumors (RECIST 1.1).You must be 18 years or older to participate in this study. This is because lung cancer is very rare in people under 18, and there is no information on how safe the study medication is for children.You are able to perform daily activities without assistance and your overall health is good (Karnofsky score of 70% or higher).You have a type of lung cancer called non-squamous non-small cell lung cancer that has spread and cannot be cured.There are no limits on the number of treatments you have received in the past.You have a history of lung disease or current signs of lung disease that require medication.You may be excluded if you have any of the following heart conditions:You have cancer that is not non-small cell lung cancer (NSCLC) or a history of cancer that may come back during the study period, except for some types of skin cancers.You are pregnant.You are allergic to AZD9291 or any similar drugs with the same chemical structure.You can swallow pills or tablets.You have had a previous biopsy that shows your disease has progressed after treatment with a specific medication. If you do not have a recent biopsy, you must be willing to have one done before starting the trial. In some cases, if you have already been tested for a specific gene mutation, a new biopsy may not be necessary for a certain part of the trial.For the second part of the study, you must have a specific type of tumor that tests positive for EGFR-T790M and have not received a certain type of medication for it before.You have already undergone treatment for your condition with a medication called EGFR TKI, and your disease has progressed. You may have had other treatments before or after EGFR TKI, but you cannot have had a specific type of EGFR TKI called third-generation EGFR TKI for the expansion phase of the trial.You are currently taking part in another study testing a new treatment.You are currently taking medication to prevent blood clots or thin your blood.You can participate in the study regardless of how many treatments you have had before.You must be able to swallow pills or tablets.You are expected to live for at least 3 more months.You may participate if you have had cancer that has spread to your brain before, but only if you meet certain requirements.
- Group 1: Treatment (navitoclax, osimertinib)
- 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
At what number of institutions is this research experiment being conducted?
"This research is actively enrolling patients at Duke University Medical Center, UC Davis Comprehensive Cancer Center, and UPCI with an additional 18 sites."
Has this medical experiment been conducted before?
"Since 2009, research has been conducted on the effectiveness of Osimertinib. The initial clinical trial was organised by AbbVie (previously Abbott) and included 29 participants. Subsequent to this study, Phase 1 drug approval for osimertinib was granted; presently there are 112 active trials located across 54 countries in over 1000 cities."
Are new participants being accepted for this trial at present?
"This clinical trial has ceased to accept enrollment, having initially gone live on March 31st 2016 and last updated on August 2nd 2022. Fortunately for those seeking other studies, there are 3,657 non-small cell lung carcinoma trials currently recruiting as well as 112 osimertinib studies with available spots."
What prior research has been conducted concerning the efficacy of Osimertinib?
"Presently, 19 trials for Osimertinib are in the third phase of development and 112 studies researching this drug exist. Though most of these tests take place at Uniondale in New York State, there is a total of 5506 clinical trial sites that offer it."
What is the quota for enrollees of this research endeavor?
"This clinical trial has ended, with the initial post on March 31st 2016 and last update dated August 2nd 2022. If you are seeking other trials for non-small cell lung carcinoma, 3657 studies are presently recruiting patients while 112 research projects include Osimertinib as a prospective treatment option."
Is Osimertinib associated with any unfavorable side effects?
"Due to the limited data on osimertinib's safety and efficacy, our team evaluated its risk as a 1 on a scale of one to three."
What are the intended outcomes of this research project?
"The primary outcome of this trial, to be measured over a 12 week period (3 cycles), is the incidence of toxicity during dose escalation. Secondary outcomes include biomarkers of apoptosis such as BCL-XL and BIM levels in tumor tissue, pharmacokinetics parameters related to osimertinib with navitoclax dosing changes, and an exploration into change in plasma concentration of EGFR T790M mutations relative to imaging responses."
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