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Tyrosine Kinase Inhibitor

osimertinib for Non-Small Cell Lung Cancer

Phase 2

Waitlist Available

Led By Thomas Stinchcombe, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

Study Summary

This trial is testing a new drug to treat advanced lung cancer in patients who have not had previous treatment.

Eligible Conditions

Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate as Assessed by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1)

Secondary outcome measures

Number of Participants With Adverse Events (AEs) as Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03

Overall Survival as Noted by Follow-up Via Composite of Telephone or Medical Record Review.

Progression Free Survival (PFS) as Measured by Response Evaluation Criteria In Solid Tumors (RECIST 1.1)

Side effects data

From 2022 Phase 2 trial • 17 Patients • NCT03434418

76%

Diarrhea

53%

Fatigue

41%

Anorexia

41%

Weight loss

35%

Dyspnea

29%

Abdominal pain

29%

Vomiting

24%

Maculopapular rash

24%

Acneiform rash

24%

Cough

Thromboembolic event

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Osimertinib

Trial Design

1Treatment groups

Experimental Treatment

Group I: osimertinibExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

osimertinib

2018

Completed Phase 2

~150

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,359 Previous Clinical Trials

3,420,292 Total Patients Enrolled

Thomas Stinchcombe, MDPrincipal InvestigatorDuke University

6 Previous Clinical Trials

139 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any precedential studies that have explored the efficacy of osimertinib?

"Presently, there are 101 trials in progress examining the effects of osimertinib. Out of these studies, 17 have entered Phase 3 testing and 4702 different centres have begun running their own investigations into this potential treatment. The primary location for these live clinical trials is Uniondale, New york."

Answered by AI

To what extent has enrollment in this research project been successful?

"Unfortunately, this trial is no longer accepting new participants. It was initially posted on June 30th 2018 and its last update occurred on the same day in 2022. If you are looking for other opportunities to participate in a clinical trial, there are presently 2045 trials searching for patients with non-small cell lung carcinoma (nsclc) and 101 studies recruiting volunteers that could benefit from osimertinib treatment."

Answered by AI

What potential adverse effects may arise from the use of osimertinib?

"Osimertinib's safety is assessed as a 2 on the scale of 1-3 since this Phase 2 trial has collected some data confirming its safety, yet there are no records to demonstrate efficacy."

Answered by AI

Are there any vacant slots for participants in this clinical trial?

"Currently, this trial is not recruiting new participants. Originally posted on June 30th 2018 and last updated two years ago, it has reached its conclusion for the time being. However, there are presently 2045 clinical trials actively enrolling patients with non-small cell lung carcinoma (nsclc) as well as 101 studies administering Osimertinib that have available spots to fill."

Answered by AI

Is this particular investigation unprecedented in its field?

"Initially researched in 2013, osimertinib was sponsored by AstraZeneca and trialled with 603 patients. After the initial study yielded positive results, Phase 1 & 2 drug approval were granted to it. Currently there are over a thousand cities worldwide participating in 101 live clinical trials of this medication across 51 nations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Osimertinib in Patients With Stage 4 Non-small Cell Lung Cancer With Uncommon EGFR Mutations

2018. "A Study Osimertinib in Patients With Stage 4 Non-small Cell Lung Cancer With Uncommon EGFR Mutations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03434418.