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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study 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 belowSelect...
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.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
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 moreSide effects data
From 2020 Phase 4 trial • 60 Patients • NCT0385355110%
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
~9850
Osimertinib
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,508 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,143 Total Patients Enrolled
National Comprehensive Cancer NetworkNETWORK
115 Previous Clinical Trials
7,462 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a bad reaction to osimertinib or similar drugs in the past.I have brain metastases causing symptoms and affecting my stability.I can swallow pills.I have not had a complete response to osimertinib or prior treatments, leaving no visible lesions treatable by LCT.My NSCLC has specific EGFR mutations and I haven't had certain treatments.You have a tumor that can be measured according to specific guidelines.I am eligible for targeted therapy on at least one cancer site.I am not pregnant, not breastfeeding, and can become pregnant.You are expected to live for at least 12 more weeks.My cancer hasn't worsened after 6-12 weeks of osimertinib treatment.I have been treated with osimertinib or a similar advanced lung cancer medication.I am a man who can father children and will use birth control during and 3 months after the study.I do not have severe illnesses like uncontrolled high blood pressure, active bleeding, or infections like hepatitis or HIV.I have had lung conditions that needed steroid treatment.I am not pregnant, breastfeeding, or if capable of having children, I am using effective birth control.My heart's electrical activity has significant irregularities.I am fully active and can carry on all pre-disease activities without restriction.I have signed and understand the consent form according to international and local laws.I am not taking, or can stop taking, strong CYP3A4 inducers 3 weeks before starting the study treatment.I cannot take osimertinib due to severe nausea, vomiting, or issues with my digestive system.My bilirubin levels are higher than normal due to my liver condition or Gilbert's syndrome.Your platelet count is less than 100,000 per microliter.Your hemoglobin level is less than 9.0 grams per deciliter.I don't have severe side effects from previous treatments, except for possible hair loss.Your liver enzymes (AST and ALT) are higher than the normal range, especially if you have cancer that has spread to your liver.I am a woman who has not had a period for the last 12 months without other health reasons.I agree to use birth control from 2 weeks before until 3 months after my study medication.Your body has too few infection-fighting white blood cells.My EGFR mutation status is confirmed by an approved test.My lung cancer is at an advanced stage and cannot be cured with surgery or radiation.My kidney function is reduced with a creatinine clearance below 50 mL/min.
Research Study Groups:
This trial has the following groups:- Group 1: Group II (no LCT)
- Group 2: Group I (LCT)
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How extensive is the participation of individuals in this research endeavor?
"Affirmative. According to information available on clinicaltrials.gov, this research is actively enlisting participants; the protocol was first distributed in January 17th 2018 and most recently adjusted on September 22nd 2022. The trial necessitates 143 individuals from 4 sites for completion."
Answered by AI
Is there still an opportunity to be a participant in this trial?
"As per clinicaltrials.gov, this medical trial is presently recruiting patients. The experiment was first announced on January 17th 2018 and the most recent update occurred on September 22nd 2022."
Answered by AI
What verifiable evidence exists that demonstrates Osimertinib's safety for treatment?
"Considering the lack of evidence demonstrating its efficacy, our team at Power gave Osimertinib a safety rating of 2."
Answered by AI
What is the breadth of locales in which this experiment is being conducted?
"At present, 4 medical centres across America are enrolling patients for this clinical trial. In addition to Houston, Denver and San Francisco, there is another clinic located in a nearby city. To reduce travel requirements it would be advisable to select the centre closest to you if you decide to participate."
Answered by AI
Can you outline the previous research conducted on Osimertinib?
"Osimertinib was initially studied in 2013 at Research Site and has since been the focus of 169 completed clinical trials. There are presently 101 active studies occurring, with many of these being conducted out of Houston, Texas."
Answered by AI
Is this an innovative research effort?
"AstraZeneca sponsored the earliest clinical trial of Osimertinib in 2013, involving 603 participants. After successful Phase 1 & 2 trials were completed, there are now 101 active studies for this drug occurring across 1059 cities in 51 countries worldwide."
Answered by AI
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