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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.
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.Side effects data
From 2020 Phase 4 trial • 60 Patients • NCT03853551Trial Design
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Who is running the clinical trial?
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- I have recovered from past treatment side effects, except for hair loss and mild nerve pain.I have a history of lung conditions needing steroid treatment.I haven't taken strong medication or supplements that affect liver enzymes in the last week.I am on blood thinners, but there may be exceptions.I have a condition that increases my risk of bleeding or am currently experiencing significant bleeding.My tumor is EGFR-T790M positive and I haven't received EGFR TKI treatment.I am mostly active and can care for myself.You are currently taking any other experimental medications.My cancer has a specific EGFR mutation.You have a measurable tumor according to specific guidelines for evaluating tumors.I am 18 years old or older.I can swallow pills.You have a white blood cell count of at least 3,000 cells per microliter.You must have at least 100,000 platelets per microliter of blood.My kidney function is normal, with creatinine levels at or below 2.0 mg/dL or clearance above 50 mL/min.I finished my last chemotherapy more than 3 weeks ago or radiotherapy more than 2 weeks ago.I haven't had bleeding issues due to low platelet count not caused by chemotherapy in the last year.I have a significant history of heart disease.I have not had major surgery in the last 3 weeks.Your white blood cell count needs to be at least 1,500 per microliter.Your total bilirubin level should be less than or equal to 1.5 times the upper limit of normal, unless you have Gilbert's syndrome.Your AST and ALT levels should not be more than three times the normal limit at the medical center where you are being treated.I do not have any severe illnesses that could interfere with the study.My lung cancer is non-squamous and cannot be cured, but has spread.I have had previous treatments for my condition.You are expected to live for more than 3 months.I can provide tissue samples from a recent biopsy after my cancer progressed, or I am willing to have a new biopsy.I have HIV and am on antiretroviral therapy.You have had a bad reaction to AZD9291 or any of its ingredients in the past.I stopped my previous EGFR-TKI treatment at least a week ago.My heart health meets the study's requirements.I have had brain metastases but meet certain conditions for treatment.Your hemoglobin level should be 8.0 grams per deciliter or higher.Your blood clotting time is within a certain range.My cancer progressed after treatment with an EGFR inhibitor.I have NSCLC or skin cancer that won't affect the study.
- 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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