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Tyrosine Kinase Inhibitor

Osimertinib for Early-Stage Non-Small Cell Lung Cancer

Phase 2

Waitlist Available

Led By Collin Blakely, MD, PhD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

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

Must have

Documented activating EGFR mutation on tumor samples by CLIA-approved test

Hemoglobin >= 9 g/dL with no blood transfusions in the 28 days prior to study entry

Must not have

Class II to IV heart failure, known coronary artery disease, or LVEF < 50%

Females who are pregnant or breastfeeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing osimertinib to treat early-stage lung cancer. Osimertinib may stop the growth of cancer cells by blocking a protein called EGFR that is found in cancer cells.

Who is the study for?

Adults over 18 with stage I-IIIA non-small cell lung cancer that has a specific EGFR mutation. They must be fit for surgery, have an ECOG Performance Status of 0-1, and meet certain blood test criteria. Excluded are those with advanced cancer stages, active second cancers, certain heart conditions, uncontrolled diseases or infections, pregnancy or breastfeeding women.

What is being tested?

The trial is testing the effectiveness of Osimertinib before surgery in patients with early-stage lung cancer that has a particular genetic change (EGFR mutation). The goal is to see if this drug can halt tumor growth by blocking the mutant proteins.

What are the potential side effects?

Osimertinib may cause side effects like diarrhea, rash, dry skin, nail changes and mouth sores. More serious but less common side effects include lung problems (like shortness of breath), heart issues (like abnormal heartbeat), and eye problems.

Eligibility Criteria

Inclusion Criteria

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

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My tumor has an EGFR mutation confirmed by a certified test.

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My hemoglobin is at least 9 g/dL and I haven't had a blood transfusion in the last 28 days.

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My kidney function is good, with a filtration rate over 50 mL/min.

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I am fully active or can carry out light work.

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A certified surgeon has approved me for lung cancer surgery.

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My PET-CT scan within the last 2 months shows stage I to IIIa lung cancer.

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My tumor is at least 1 cm big.

Exclusion Criteria

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

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I have heart issues like heart failure, artery disease, or low heart pump function.

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I am not pregnant or breastfeeding.

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I have a history of lung scarring or inflammation not caused by an infection.

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I have another cancer, but it's completely treated.

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My cancer is at stage IIIB or has spread to distant areas.

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I have a digestive system condition that affects how my body absorbs food.

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I haven't taken any prohibited medications in the last 14 days.

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I have heart problems that are not being treated or controlled.

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My cancer has spread to the brain or spinal cord.

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I am not on medications that affect heart rhythm or strongly change drug breakdown.

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I have a history of heart problems.

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I do not have severe diseases, active infections, or tuberculosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Percentage of Participants With a Major Pathological Response (MPR)

Secondary study objectives

Disease-free Survival Rate (DFS)

Mean Disease-free Survival (DFS)

Median Percentage Change in Tumor Burden (Depth of Response)

+6 more

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

1Treatment groups

Experimental Treatment

Group I: Treatment (osimertinib)Experimental Treatment2 Interventions

Participants receive 80mg osimertinib orally, once a day (PO QD) on days 1-28. Treatment repeats every 28 days for a minimum of 1 cycle prior to surgery in the absence of disease progression or unacceptable toxicity. Investigators will have the option to give a second cycle of study drug prior to surgery if clinically indicated. Depending on the timing of the final scans, patients may ultimately receive up to two weeks additional therapy with study drug beyond end of cycle 1 (or cycle 2) while awaiting surgery. Patients then undergo surgical resection of their cancer. No treatment with the study drug will be given after surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Osimertinib

2017

Completed Phase 4

~1120

Therapeutic Conventional Surgery

2005

Completed Phase 3

~9630