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Tyrosine Kinase Inhibitor

Osimertinib + Chemotherapy for Lung Cancer

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 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
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

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

Find a Location

Who is running the clinical trial?

Guardant Health, Inc.Industry Sponsor
19 Previous Clinical Trials
59,111 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,940 Previous Clinical Trials
588,321 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,287 Previous Clinical Trials
288,619,565 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
~97 spots leftby May 2025
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