What side effects are associated with this type of intervention?

Common treatments for lung cancer, especially those involving EGFR Tyrosine Kinase Inhibitors like Osimertinib, often have side effects such as fatigue, diarrhea, rash, and increased liver function tests. Other treatments, such as chemotherapy combined with immunotherapy (e.g., pembrolizumab), can cause adverse effects including nausea, anemia, neutropenia, and severe skin reactions. Antiangiogenic therapies may lead to tumor-related bleeding, particularly in patients with squamous cell histology or centrally located tumors. Overall, while these treatments can be effective, they are associated with a range of side effects that need to be managed carefully.

What prior FDA approvals exist?

Osimertinib is an FDA-approved EGFR tyrosine kinase inhibitor (TKI) used for treating non-small cell lung cancer (NSCLC) with specific EGFR mutations. Other FDA-approved EGFR TKIs for NSCLC include erlotinib, gefitinib, and afatinib, which target various EGFR mutations. Additionally, sotorasib and adagrasib are approved for KRAS G12C-mutated NSCLC. These targeted therapies have shown efficacy in patients with specific genetic alterations, providing personalized treatment options for lung cancer.

What other types of research exist?

Promising alternatives to Osimertinib for lung cancer patients include other EGFR TKIs such as Afatinib and Dacomitinib. Additionally, novel therapies like combination treatments involving immunotherapy (e.g., Pembrolizumab) and chemotherapy (e.g., platinum-doublet chemotherapy) have shown improved outcomes. Investigational agents like Amivantamab, a bispecific antibody targeting EGFR and MET, and novel multitargeted kinase inhibitors such as Mobocertinib are also emerging as potential options.

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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

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial tests a combination of osimertinib, surgery, and radiation therapy in patients with advanced lung cancer with specific genetic mutations. It focuses on patients who haven't responded to or have become resistant to previous treatments. The treatment aims to stop cancer cell growth, remove tumors, and eliminate remaining cancer cells. Osimertinib is a medication approved for treating certain types of lung cancer, including those resistant to earlier treatments.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

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

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

Primary study objectives

Progression free survival (PFS)

Secondary study objectives

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

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

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

~9890

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

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.