Your session is about to expire
← Back to Search
Tyrosine Kinase Inhibitor
Osimertinib + Tegavivint for Lung Cancer
Phase 1
Recruiting
Led By Regan M Memmott
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with treated brain metastases are asymptomatic and not requiring ongoing treatment
The patient must be able to swallow pills
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study Summary
This trial is to find out the benefits and side effects of two drugs, osimertinib and tegavivint, in treating patients with lung cancer that has spread to other places in the body.
Who is the study for?
Adults with metastatic non-small cell lung cancer that has a specific mutation (EGFR) can join this trial. They must have good organ function, no history of significant heart disease or other serious illnesses, and not be pregnant or breastfeeding. Prior treatment with EGFR inhibitors disqualifies them.Check my eligibility
What is being tested?
The trial is testing the combination of Osimertinib and Tegavivint as initial treatment for lung cancer to determine the best dose and assess benefits/side effects. These drugs aim to block enzymes that tumor cells need to grow.See study design
What are the potential side effects?
Possible side effects include issues affecting organs due to enzyme inhibition, which could lead to abnormal cell growth control, potential heart problems given past drug reactions, and general risks associated with taking new medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My brain metastases have been treated, I have no symptoms, and I don't need ongoing treatment.
Select...
I can swallow pills.
Select...
My cancer has a specific change in the EGFR gene confirmed by a biopsy.
Select...
I had hepatitis C but have been treated and now have no detectable virus.
Select...
My hepatitis B virus load is undetectable with treatment.
Select...
My lung cancer has spread to other parts of my body.
Select...
I can take care of myself but might not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose
Secondary outcome measures
Duration of response
Heart rate
Overall survival
+1 moreOther outcome measures
Circulating tumor deoxyribonucleic acid (ctDNA)
Positron-Emission Tomography
Osimertinib (AZD9291) PK
+2 moreSide effects data
From 2020 Phase 4 trial • 60 Patients • NCT0385355110%
Blood creatine phosphokinase increased
10%
Fatigue
8%
Decreased appetite
8%
Diarrhoea
8%
Cough
7%
Mucosal inflammation
7%
Rash
7%
Pain in extremity
7%
Constipation
7%
Thrombocytopenia
7%
Paronychia
3%
Dyspnoea
2%
Dengue fever
2%
Disease progression
2%
Cardio-respiratory arrest
2%
Cataract
2%
Mouth Ulceration
2%
Deep Vein Thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (osimertinib, tegavivint)Experimental Treatment2 Interventions
Patients receive osimertinib PO QD on days 1-28 and tegavivint IV on day 1. Treatment repeats every 28 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive osimertinib PO QD on days 1-28. Treatment repeats every 28 days for 4 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
2017
Completed Phase 4
~1010
Tegavivint
2018
Completed Phase 1
~30
Find a Location
Who is running the clinical trial?
Ohio State University Comprehensive Cancer CenterLead Sponsor
320 Previous Clinical Trials
290,149 Total Patients Enrolled
Regan M MemmottPrincipal InvestigatorOhio State University Comprehensive Cancer Center
Regan M Memmott, M.D., Ph.DPrincipal InvestigatorOhio State University Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had lung conditions that required steroid treatment.You must have a certain amount of a type of white blood cell called neutrophils in your blood.My heart condition meets specific medical criteria.I have issues that could affect my ability to absorb pills, like severe nausea or a major gut surgery.My brain metastases have been treated, I have no symptoms, and I don't need ongoing treatment.I can swallow pills.You have a low white blood cell count.My heart's electrical activity is normal, with no significant abnormalities.Your total bilirubin level should be within a certain range, unless you have Gilbert's syndrome.My heart function is classified as class 2B or better, despite my history of heart issues or treatments.I am not pregnant or breastfeeding.I have conditions or take medications that could affect my heart's rhythm.The average time between heartbeats is longer than 470 milliseconds.You are expected to live for more than three months.I have not had a major heart event or clot in the past 6 months.I have NSCLC and no other active cancers, except for certain low-risk or localized cancers.I am not taking any strong CYP3A4 inducers, or can stop them before starting the study treatment.I do not have any unmanaged ongoing illnesses.I have been treated with an EGFR inhibitor before.I haven't taken any experimental drugs or immunotherapy within the last 3 months or five half-lives of the compound, whichever is longer.I am not allergic to BC2059, AZD9291, or their ingredients.Your hemoglobin level is 90 grams per liter or higher.My kidney function, measured by creatinine or GFR, is within the required range.I have recovered from side effects of previous cancer treatments, except for hair loss.My cancer has a specific change in the EGFR gene confirmed by a biopsy.Your platelet count is at least 100,000 per microliter.I had hepatitis C but have been treated and now have no detectable virus.You have a measurable tumor according to specific guidelines.My hepatitis B virus load is undetectable with treatment.My cancer has a T790M mutation and I haven't been treated with EGFR TKIs.Your heart's pumping ability is below the normal range as measured by a heart scan or ultrasound.I am 18 years old or older.My lung cancer has spread to other parts of my body.Your liver function tests should be within a certain range, and if you have liver metastases, the range is a little higher.I can take care of myself but might not be able to do heavy physical work.My doctor says I don't need immediate treatment for my brain metastases or leptomeningeal disease.I have another cancer, but it won't affect this trial's treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (osimertinib, tegavivint)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment a pioneering endeavor?
"In the near decade since Osimertinib was introduced in 2013, a total of 101 studies have been conducted across 51 countries and 1059 cities. This drug developed by AstraZeneca underwent Phase 1 & 2 approval involving 603 volunteer participants. Since then, 31 additional trials have been completed to further evaluate its efficacy."
Answered by AI
Is there capacity for patients to join this clinical trial?
"Correct. Clinicaltrials.gov data indicates that this clinical investigation, which was originally made public on January 18th 2022, is currently accepting applications for participation. This endeavour requires the recruitment of 18 individuals from a single site."
Answered by AI
How many persons have registered for this research endeavor?
"Indeed, the information posted on clinicaltrials.gov indicates that recruitment for this medical trial has been ongoing since January 18th 2022 and continues to this day. Altogether, there are 18 open spots at a single location."
Answered by AI
Is there any evidence of prior research on the efficacy of Osimertinib?
"Currently, there are 17 Phase 3 trials for Osimertinib and 101 active studies in total. While Uniondale, New york is home to several of these programs, 4702 other locations across the world have clinical trials involving this drug."
Answered by AI
Are there any adverse effects associated with the ingestion of osimertinib?
"As this is an early-phase clinical trial there has been limited testing of osimertinib's efficacy and safety, resulting in a score of 1."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger