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Treatment (osimertinib) for Non-Small Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center, Grosse Pointe Woods, MINon-Small Cell Lung Cancer+3 MoreOsimertinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trialstudies a drug to help stop the growth of advanced or recurring non-small cell lung cancer with an EGFR mutation.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IV Non-small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to 5 years

Year 5
Biomarkers of response to treatment through retrospective analyses of pre-treatment tumor tissue
Characterization of molecular markers of response to treatment in circulating tumor deoxyribonucleic acid (ctDNA)
Year 5
Overall survival (OS)
Year 5
Progression-free survival (PFS)
Up to 5 years
Best objective response
Identification of resistance mechanisms to osimertinib through post-progression tumor biopsies and ctDNA
Incidence of adverse events

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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Osimertinib
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Side Effects for

Single Arm
10%Blood creatine phosphokinase increased
10%Fatigue
8%Decreased appetite
8%Diarrhoea
8%Cough
7%Thrombocytopenia
7%Pain in extremity
7%Constipation
7%Rash
7%Mucosal inflammation
7%Paronychia
3%Dyspnoea
2%Cataract
2%Cardio-respiratory arrest
2%Deep Vein Thrombosis
2%Mouth Ulceration
2%Dengue fever
2%Disease progression
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT03853551) in the Single Arm ARM group. Side effects include: Blood creatine phosphokinase increased with 10%, Fatigue with 10%, Decreased appetite with 8%, Diarrhoea with 8%, Cough with 8%.

Trial Design

1 Treatment Group

Treatment (osimertinib)
1 of 1

Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Treatment (osimertinib) · No Placebo Group · Phase 2

Treatment (osimertinib)
Drug
Experimental Group · 1 Intervention: Osimertinib · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,153 Previous Clinical Trials
41,162,289 Total Patients Enrolled
Zofia PiotrowskaPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with a specific type of lung cancer called non-small cell lung cancer (NSCLC) and it has been confirmed by a pathology report.
You have advanced stage cancer that has either spread to other parts of the body, cannot be treated with multiple therapies, or has come back after being treated before.
Your blood hemoglobin level must be at least 9.0 grams per liter, as measured within four weeks before you join the study.
Your blood test taken within the last month shows that you have enough white blood cells called neutrophils.
You have a specific type of EGFR gene mutation called an "exon 20 insertion mutation" that has been confirmed by a certified lab.
Your testing results will be submitted through a specific online tool, and a study leader will review them.
You have a disease that can be measured and the measurements must have been taken within 4 weeks before joining the study.
You must have received treatment before for your advanced lung cancer. There is no limit on the number of previous treatments.
You should have a good performance status, which means you can carry out daily tasks without difficulty.
Your white blood cell count must be at least 3,000/mcL within the past 4 weeks before you can participate.
References

Frequently Asked Questions

Are there vacancies left in this clinical experiment for participants?

"Affirmative. Clinicaltrials.gov's records show that recruitment for this research is ongoing, beginning with it's initial post on April 5th 2018 and most recently updated on December 10th 2022. The investigation requires 20 people to be recruited from 100 medical facilities." - Anonymous Online Contributor

Unverified Answer

How extensive is the current participant pool for this clinical trial?

"20 participants, who satisfy the necessary requirements, are needed to complete this trial. People can join from two sites: Illinois CancerCare - Washington in Washington, Iowa or Illinois CancerCare-Dixon in Dixon, Kansas." - Anonymous Online Contributor

Unverified Answer

Is this an unprecedented research project?

"Currently, 102 trials are underway for osimertinib in 1061 cities across 51 nations. This medication's evaluation and testing first began in 2013 under the auspices of AstraZeneca with 603 participants. From this point up until now, 31 such studies have been successfully concluded." - Anonymous Online Contributor

Unverified Answer

Has the FDA certified osimertinib for therapeutic use?

"The safety rating of osimertinib is a 2 due to limited evidence in Phase 2 trials that suggests relative security, however there are no results yet indicating its efficacy." - Anonymous Online Contributor

Unverified Answer

Could you please provide a synopsis of the past research done related to osimertinib?

"Currently, there are 102 studies regarding osimertinib in progress with 17 of those trials having reached Phase 3. Most of these investigations into this treatment occur at the Uniondale site; however, 5,031 locations worldwide run clinical experiments for osimertinib." - Anonymous Online Contributor

Unverified Answer

In which sites can this clinical experiment be accessed?

"A multitude of facilities are on-board to facilitate this medical trial, such as Illinois CancerCare - Washington in Washington, Iowa; Illinois CancerCare-Dixon in Dixon, Kansas; and Jennie Edmundson Memorial Hospital in Council Bluffs, Michigan." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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