What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC), particularly EGFR Tyrosine Kinase Inhibitors (TKIs) like Osimertinib, often cause side effects such as diarrhea, rash, dry skin, and nail toxicity. Other EGFR TKIs, such as erlotinib and gefitinib, share similar side effects. Additionally, immune checkpoint inhibitors like pembrolizumab can lead to fatigue, nausea, and increased liver function tests. Chemotherapy agents, frequently used in combination with these targeted therapies, may result in neutropenia, anemia, and gastrointestinal disturbances.

What prior FDA approvals exist?

Osimertinib is an FDA-approved EGFR Tyrosine Kinase Inhibitor (TKI) used for the treatment of NSCLC with specific EGFR mutations. Other FDA-approved EGFR TKIs for NSCLC include Erlotinib and Afatinib, which target EGFR mutations to inhibit cancer cell growth. Additionally, Sotorasib and Adagrasib are approved for NSCLC with KRAS G12C mutations. Immunotherapies such as Pembrolizumab and Nivolumab, often combined with chemotherapy, are also approved for various subtypes of NSCLC, providing a broader range of treatment options.

What other types of research exist?

Currently, osimertinib remains the best first-line treatment for NSCLC patients with EGFR mutations. EGFR-TKI plus chemotherapy combination therapies are being investigated but are not yet established as standard alternatives.

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Tyrosine Kinase Inhibitor

Osimertinib + SRS for Lung Cancer

Phase 2

Recruiting

Led By Shilo V Lefresne, MD, FRCPC

Research Sponsored by British Columbia Cancer Agency

Eligibility Criteria Checklist

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

Must have

ECOG performance status 0-2

Epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations (either alone or in combination with other EGFR mutations)

Must not have

Patients with symptomatic CNS metastases who are neurologically unstable

Patients taking any drugs that are known to prolong QT interval that can't be withdrawn prior to Osimertinib

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial is testing osimertinib alone and with precise radiation therapy in patients with a specific type of lung cancer that has spread to the brain. Osimertinib blocks a protein that helps cancer grow, while the radiation therapy targets brain tumors with focused radiation.

Who is the study for?

This trial is for adults with a specific lung cancer (NSCLC) that has spread to the brain, who have not had prior treatment and whose cancer cells show certain mutations (EGFR). Participants must be in stable condition, able to follow study procedures, and willing to use effective contraception. Those with other active cancers, severe brain symptoms, or conditions affecting study participation are excluded.

What is being tested?

The study compares two approaches: one group receives Osimertinib alone while the other gets Osimertinib plus Stereotactic RadioSurgery (SRS), which is a precise radiation therapy. This phase II trial aims to determine if adding SRS improves outcomes for patients with brain metastases from NSCLC.

What are the potential side effects?

Osimertinib may cause diarrhea, rash, dry skin, nail changes and mouth sores. Rarely it can affect heart rhythm or cause lung problems. SRS might lead to headaches or fatigue shortly after treatment; long-term effects include potential memory issues.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself and perform daily activities.

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My cancer has specific EGFR mutations.

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I am eligible for and agree to follow the treatment plan with osimertinib as my first line of therapy.

Exclusion Criteria

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

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I have brain metastases causing symptoms and affecting my neurological stability.

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I am not taking any medication that affects my heart's rhythm.

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I have been diagnosed with multiple sclerosis.

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I have brain metastases causing symptoms other than headache, nausea, or controlled seizures.

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I have had brain surgery or radiation for brain metastases.

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I do not have uncontrolled lupus, scleroderma, or similar conditions that would prevent radiotherapy.

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My cancer has spread to the lining of my brain and spinal cord.

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I am not taking, nor can I stop taking, drugs or supplements that affect liver enzyme CYP3A4.

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I need surgery to relieve pressure in my brain from cancer spread.

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I haven't taken any experimental drugs recently.

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I have been treated with osimertinib or another EGFR inhibitor.

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

Intracranial progression free survival

Secondary study objectives

Exposure to osimertinib

Intracranial overall response rate

Neurocognitive function

+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

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Osimertinib aloneExperimental Treatment1 Intervention

Osimertinib 80mg PO daily

Group II: SRS + OsimertinibActive Control2 Interventions

Stereotactic radiotherapy will be delivered in 1-5 fractions to each brain metastases according to the volume and location of the metastases and clinician discretion. Osimertinib will start 1-7 days post radiotherapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Osimertinib

FDA approved

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include EGFR Tyrosine Kinase Inhibitors (TKIs) like Osimertinib, chemotherapy, and immunotherapy. Osimertinib targets and inhibits the epidermal growth factor receptor (EGFR) tyrosine kinase, which is often mutated in NSCLC, thereby blocking the signaling pathways that promote cancer cell growth and survival. Chemotherapy works by killing rapidly dividing cells, including cancer cells, but can also affect normal cells, leading to side effects. Immunotherapy, such as pembrolizumab, enhances the body's immune response against cancer cells by targeting immune checkpoints. These treatments are crucial for NSCLC patients as they offer targeted and systemic approaches to control and potentially eradicate the cancer, improving survival rates and quality of life.

An overview of osimertinib as a treatment of non-small cell lung cancer (NSCLC): an update.