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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

Must not have

Currently receiving (or unable to stop prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of CYP3A4

Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am taking or can't stop taking strong CYP3A4 inducers.

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I do not have active infections like hepatitis B, C, or HIV.

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I do not have any severe illnesses or uncontrolled high blood pressure.

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I cannot take pills due to severe nausea, vomiting, or past major gut surgery.

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I have not had major surgery in the last 2 weeks.

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I have had lung conditions that needed steroid treatment.

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My heart health meets the study's requirements.

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I have a serious lung condition affecting the tissue and space around the air sacs.

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I haven't taken any experimental drugs recently.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine the progression-free survival

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1120

Carboplatin

2014

Completed Phase 3

~6120