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Tyrosine Kinase Inhibitor

Osimertinib for Non-Small Cell Lung Cancer (ELIOS Trial)

Phase 2
Waitlist Available
Led By Zosia Piotrowska, MD
Research Sponsored by AstraZeneca
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 at baseline and every 8 weeks from enrolment until 3.5 years and every 10 weeks until disease progression or death or end of study for max 4.2 years
Awards & highlights

ELIOS Trial Summary

This trial is testing a new cancer drug for people with a specific type of lung cancer. The trial is open to anyone who meets the criteria, and the drug will be given to them for free.

Eligible Conditions
  • Non-Small Cell Lung Cancer with EGFR Mutation

ELIOS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and every 8 weeks from enrolment until 3.5 years and every 10 weeks until disease progression or death or end of study for max 4.2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and every 8 weeks from enrolment until 3.5 years and every 10 weeks until disease progression or death or end of study for max 4.2 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
Proportion of patients with a given tumour genetic and proteomic marker at the point of disease progression as defined by the Investigator
Secondary outcome measures
Disease Control Rate
Duration of Response (DoR)
ORR in patient subgroups defined by molecular profile
+8 more
Other outcome measures
Adverse events graded by Common Terminology Criteria for Adverse Events version 4.0

Side effects data

From 2020 Phase 4 trial • 60 Patients • NCT03853551
10%
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

ELIOS Trial Design

1Treatment groups
Experimental Treatment
Group I: OsimertinibExperimental Treatment1 Intervention
An oral, potent, selective, irreversible inhibitor of both EGFR-tyrosine kinase inhibitor sensitizing and resistance mutations in non-small cell lung cancer
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
2017
Completed Phase 4
~1010

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,257 Previous Clinical Trials
288,593,630 Total Patients Enrolled
ParexelIndustry Sponsor
303 Previous Clinical Trials
100,670 Total Patients Enrolled
Zosia Piotrowska, MDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
284 Total Patients Enrolled

Media Library

Osimertinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03239340 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Osimertinib
Non-Small Cell Lung Cancer Clinical Trial 2023: Osimertinib Highlights & Side Effects. Trial Name: NCT03239340 — Phase 2
Osimertinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03239340 — Phase 2

Frequently Asked Questions

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

How can I sign up for the clinical trial?

"This study aims to enroll 154 individuals that have been diagnosed with lung cancer. All participants must be between 18-130 years old."

Answered by AI

Has the food and drug administration allowed osimertinib to be sold?

"Osimertinib's safety is estimated to be a 2. This is based on it being in Phase 2 of clinical trials, where there is some evidence backing its safety but none for efficacy."

Answered by AI

How many individuals are taking part in this research project?

"Unfortunately, this study is no longer looking for participants. However, when it was active, the trial was posted on 5/30/2018 and edited on 9/28/2022. If you are interested in other studies, there are1959 trials for patients with lung cancer and 105 osimertinib studies that are still recruiting individuals."

Answered by AI

Are middle-aged patients eligible for this research?

"According to the inclusion criteria, people aged 18-130 are eligible for this trial. There have been 45 studies done on people younger than 18 and 2056 trials completed with patients over the age of 65."

Answered by AI

What are the most similar drugs to Osimertinib that have been studied before?

"First appearing in 2013, osimertinib has had 29 completed studies. Right now, 105 more are underway with numerous sites in Atlanta, Georgia."

Answered by AI

Does this clinical trial break new ground?

"As of now, there are 105 clinical trials underway for Osimertinib in 1061 cities and 51 different nations. The first study was completed in 2013 by AstraZeneca. This initial research had 603 individuals taking part and cleared Phase 1 & 2 of drug approval. In the 8 years since 2013, 29 more studies have been carried out."

Answered by AI

Are you looking for more participants for this clinical trial?

"The study you are referencing is not looking for patients at this time, however that may change in the future. Last updated on 9/28/2022, this study was first posted on 5/30/2018. It's worth noting that there are 2064 other studies which are currently recruiting patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Molecular Profiling Study of Patients With EGFR Mutation-positive Locally Advanced or Metastatic NSCLC Treated With Osimertinib
2018. "A Molecular Profiling Study of Patients With EGFR Mutation-positive Locally Advanced or Metastatic NSCLC Treated With Osimertinib". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03239340.
~23 spots leftby Apr 2025
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