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Tyrosine Kinase Inhibitor

Osimertinib + Chemotherapy for Lung Cancer

Q: Is this study taking place at more than one hospital in our state?

<p>Hackensack Meridian Health in Hackensack, <a href="https://www.withpower.com/clinical-trials/new-jersey">New jersey</a>; Sarah Cannon Research Institute in Nashville, <a href="https://www.withpower.com/clinical-trials/tennessee">Tennessee</a>; Memorial Sloan Kettering Nassau (Limited Protocol Activities) in Uniondale, <a href="https://www.withpower.com/clinical-trials/california">California</a> are <a href="https://www.withpower.com/clinical-trials/all">all</a> locations where this study is being conducted. There are a total of 12 sites.</p>

Phase 2

Recruiting

Led By Helena Yu, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Willing to use highly effective contraceptive measures if of child-bearing potential or if the patient's sexual partner is a woman of child-bearing potential

Biopsy proven metastatic non-small cell lung cancer, confirmed at enrolling institution

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial will compare osimertinib alone to osimertinib with chemotherapy in people with metastatic lung cancer that has a change in the EGFR gene.

Who is the study for?

This trial is for adults over 18 with metastatic non-small cell lung cancer and a specific EGFR mutation. They must be able to swallow pills, have not had certain treatments before, and their organs must function well. Pregnant women or those with significant health issues like interstitial lung disease or uncontrolled diseases are excluded.Check my eligibility

What is being tested?

Researchers are testing if adding chemotherapy (carboplatin and pemetrexed) to osimertinib, which is the usual treatment for this type of lung cancer, can better stop the cancer from growing compared to osimertinib alone.See study design

What are the potential side effects?

Osimertinib may cause diarrhea, rash, dry skin, nail changes while chemotherapy can lead to nausea, fatigue, low blood counts increasing infection risk. Side effects vary by individual and should be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am willing to use effective birth control if I or my partner can become pregnant.

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My lung cancer has spread and was confirmed with a biopsy.

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I can swallow pills.

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I have a tumor that can be measured and hasn't been treated with radiation.

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My cancer has a specific genetic change known as an EGFR mutation.

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I am 18 years old or older.

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I am able to care for myself but may not be able to do active work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Determine the progression-free survival

Secondary outcome measures

overall response rate

Side effects data

From 2020 Phase 4 trial • 60 Patients • NCT03853551

10%

Blood creatine phosphokinase increased

10%

Fatigue

Decreased appetite

Diarrhoea

Cough

Mucosal inflammation

Rash

Pain in extremity

Constipation

Thrombocytopenia

Paronychia

Dyspnoea

Dengue fever

Disease progression

Cardio-respiratory arrest

Cataract

Mouth Ulceration

Deep Vein Thrombosis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

2Treatment groups

Experimental Treatment

Group I: Osimertinib plus Carboplatin and PemetrexedExperimental Treatment3 Interventions

All patients will receive osimertinib 80mg orally daily. Patients receive Carboplatin (AUC 5 IV q 3 weeks) and Pemetrexed (500mg/m2 IV q 3 weeks) for a total of 4 cycles followed by pemetrexed maintenance from cycle 8 onwards. Patients will be required to complete a pill diary beginning at Cycle 4.

Group II: Osimertinib aloneExperimental Treatment1 Intervention

All patients will receive osimertinib 80mg orally daily. Subjects randomized to Arm A may be dispensed osimertinib for 2 cycles from Cycle 4 onward. Patients will be required to complete a pill diary beginning at Cycle 4.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Osimertinib

2017

Completed Phase 4

~1010

Carboplatin

2014

Completed Phase 3

~6670

Pemetrexed

2014

Completed Phase 3

~5250

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Guardant Health, Inc.Industry Sponsor

19 Previous Clinical Trials

54,644 Total Patients Enrolled

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,327 Total Patients Enrolled

AstraZenecaIndustry Sponsor

4,271 Previous Clinical Trials

288,612,132 Total Patients Enrolled

Media Library

Osimertinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04410796 — Phase 2

Non-Small Cell Lung Cancer Research Study Groups: Osimertinib plus Carboplatin and Pemetrexed, Osimertinib alone

Non-Small Cell Lung Cancer Clinical Trial 2023: Osimertinib Highlights & Side Effects. Trial Name: NCT04410796 — Phase 2

Osimertinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04410796 — Phase 2

Frequently Asked Questions

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

What are the most common reasons that patients take Osimertinib?

"Osimertinib is not only indicated for the treatment of advanced thymoma, but also neuroendocrine carcinoma and testicular cancer."

Answered by AI

Could you explain any risks associated with Osimertinib?

"Osimertinib's safety is based on Phase 2 trial data, meaning that while there is some evidence supporting its safety, there is none indicating that it is an effective treatment."

Answered by AI

Are we still looking for test subjects for this experiment?

"Yes, this information is available on the website clinicaltrials.gov. The trial was posted on May 28th 2020 and has been updated as recently as October 12th of this year."

Answered by AI

What is the total number of people who are allowed to join this trial?

"In order to run this clinical trial, the sponsor, AstraZeneca, needs a total of 571 patients that meet specific inclusion criteria. The research will be conducted in Hackensack Meridian Health and Sarah Cannon Research Institute located in Hackensack, New jersey and Nashville, Tennessee respectively."

Answered by AI

What are the most similar medical studies to Osimertinib?

"Osimertinib was first discovered in 2002 and has undergone 1068 clinical trials since its inception. Out of these 887 are active studies, a large portion of which taking place in Hackensack, New jersey."

Answered by AI

Is this study taking place at more than one hospital in our state?

"Hackensack Meridian Health in Hackensack, New jersey; Sarah Cannon Research Institute in Nashville, Tennessee; Memorial Sloan Kettering Nassau (Limited Protocol Activities) in Uniondale, California are all locations where this study is being conducted. There are a total of 12 sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung Cancers

2020. "Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04410796.

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