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Tyrosine Kinase Inhibitor

Osimertinib + Surgery + Radiation for Lung Cancer

Phase 2
Waitlist Available
Led By Yasir Elamin
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Females of childbearing potential must not be breast feeding and must have a negative serum or urine pregnancy test
To be eligible for randomization, patients must meet all the inclusion criteria and have no progression of disease after 6-12 weeks of osimertinib per RECIST 1.1
Must not have
Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable
Previous treatment with osimertinib, or a 3rd generation EGFR TKI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

Summary

This trial is studying how well osimertinib, surgery, and radiation therapy work together to treat patients with EGFR mutated non-small cell lung cancer.

Who is the study for?
This trial is for adults with stage IIIB or IV non-small cell lung cancer that has specific EGFR mutations. They must be in good physical condition, not have had certain previous treatments, and be able to take oral medication. Women of childbearing age must use contraception and not be pregnant or breastfeeding.Check my eligibility
What is being tested?
The NORTHSTAR study is testing the combination of osimertinib (a drug blocking enzymes that promote tumor growth), surgery, and radiation therapy to see if they are more effective together in treating advanced lung cancer with EGFR mutations.See study design
What are the potential side effects?
Osimertinib may cause side effects like diarrhea, rash, dry skin, nail changes, mouth sores; less commonly it can affect the heart rhythm or cause inflammation in the lungs. Surgery and radiation can lead to pain, fatigue, scarring at the surgical site and potential complications from anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not pregnant, not breastfeeding, and can become pregnant.
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My cancer hasn't worsened after 6-12 weeks of osimertinib treatment.
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I am fully active and can carry on all pre-disease activities without restriction.
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I am a woman who has not had a period for the last 12 months without other health reasons.
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My EGFR mutation status is confirmed by an approved test.
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My lung cancer is at an advanced stage and cannot be cured with surgery or radiation.

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 stability.
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I have been treated with osimertinib or a similar advanced lung cancer medication.
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I do not have severe illnesses like uncontrolled high blood pressure, active bleeding, or infections like hepatitis or HIV.
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I have had lung conditions that needed steroid treatment.
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I am not pregnant, breastfeeding, or if capable of having children, I am using effective birth control.
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My heart's electrical activity has significant irregularities.
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I cannot take osimertinib due to severe nausea, vomiting, or issues with my digestive system.
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My kidney function is reduced with a creatinine clearance below 50 mL/min.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 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
Progression free survival (PFS)
Secondary outcome measures
Incidence of adverse events
Overall survival
PFS in oligometastatic subgroup
+2 more

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: Group II (no LCT)Experimental Treatment1 Intervention
Patients receive osimertinib PO QD. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Group II: Group I (LCT)Experimental Treatment3 Interventions
Patients receive osimertinib PO QD for 6-12 weeks. Patients then undergo surgery and/or radiation therapy daily for 5 consecutive days every week for up to 8 weeks. Patients continue osimertinib during and after radiation therapy. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9870
Osimertinib
FDA approved

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
Lung cancer treatments, particularly for non-small cell lung cancer (NSCLC), include EGFR Tyrosine Kinase Inhibitors (TKIs) like Osimertinib, which block the activity of the epidermal growth factor receptor (EGFR) that is often mutated in cancer cells, thereby inhibiting tumor growth and proliferation. Chemotherapy works by targeting rapidly dividing cells, causing cell death, while immunotherapy boosts the body's immune system to recognize and attack cancer cells. Radiation therapy uses high-energy rays to kill or shrink tumors. These treatments are crucial as they target specific mechanisms of cancer cell survival and proliferation, offering personalized and effective treatment options for lung cancer patients.
An overview of osimertinib as a treatment of non-small cell lung cancer (NSCLC): an update.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,228 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,002 Previous Clinical Trials
1,794,106 Total Patients Enrolled
National Comprehensive Cancer NetworkNETWORK
117 Previous Clinical Trials
7,652 Total Patients Enrolled

Media Library

Osimertinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03410043 — Phase 2
Lung Cancer Research Study Groups: Group II (no LCT), Group I (LCT)
Lung Cancer Clinical Trial 2023: Osimertinib Highlights & Side Effects. Trial Name: NCT03410043 — Phase 2
Osimertinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03410043 — Phase 2
~20 spots leftby Jun 2025