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Tyrosine Kinase Inhibitor
Osimertinib + Ramucirumab for Lung Cancer
Phase 2
Waitlist Available
Led By Xiuning Le, MD PhD
Research Sponsored by Xiuning Le
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The patient's urinary protein is ≤ 1+ on dipstick or routine urinalysis (UA; if urine dipstick or routine analysis is ≥ 2+, a 24-hour urine collection for protein must demonstrate < 1000 mg of protein in 24 hours to allow participation in this protocol).
Age ≥ 18 years at the time of consent.
Must not have
The patient has a prior history of GI perforation/fistula (within 6 months of first dose of protocol therapy) or risk factors for perforation.
The patient has experienced any Grade 3-4 GI bleeding within 3 months prior to first dose of protocol therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether adding ramucirumab to osimertinib improves progression-free survival for EGFR-mutated lung cancer patients.
Who is the study for?
Adults with non-squamous, non-small cell lung cancer (NSCLC) that has specific EGFR mutations and is advanced or metastatic. Participants must be able to swallow pills, have good organ function, no significant bleeding risks or recent serious blood clots, and not have had certain other cancers in the last 2 years. They should not have used drugs like osimertinib before and need to use contraception if of childbearing potential.
What is being tested?
The trial tests whether adding Ramucirumab to Osimertinib improves progression-free survival compared to using Osimertinib alone in NSCLC patients. Progression-free survival means how long patients live without their disease getting worse. The study randomly assigns participants into two groups following a 2:1 ratio favoring the combination treatment.
What are the potential side effects?
Possible side effects include issues related to liver function changes, bleeding complications, high blood pressure, gastrointestinal problems such as perforation or fistula formation, heart-related events including abnormal rhythm or thromboembolic events like stroke or heart attack.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My urine protein levels are low enough to meet the trial's requirements.
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I am 18 years old or older.
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My cancer has spread and cannot be cured with surgery or radiation.
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My lung cancer has a specific genetic change (EGFR Exon 19 deletion).
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I am fully active or can carry out light work.
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My lung cancer is non-squamous and confirmed by lab tests.
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My kidney function, measured by creatinine levels or clearance, is within the required range.
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My liver enzymes are within acceptable limits, even with liver metastasis.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a GI perforation or am at risk for one in the last 6 months.
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I have had severe GI bleeding in the last 3 months.
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I have severe liver disease with complications like confusion or fluid in my abdomen.
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I have been treated with EGFR inhibitors like erlotinib or osimertinib.
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I have had a serious blood clot, excluding minor ones, in the last 3 months.
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I have not coughed up blood or have a tumor invading major blood vessels.
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I have been treated with medications like bevacizumab or similar.
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I have not had major surgery in the last 28 days or minor surgery in the last 7 days, and I do not plan to have major surgery during the trial.
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I have an eye condition that hasn't been diagnosed.
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I have not had a serious wound, ulcer, or bone fracture in the last 28 days.
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I have had lung conditions like ILD or radiation pneumonitis that needed steroids.
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I have conditions or take medications that could affect my heart's rhythm.
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I cannot take osimertinib due to severe nausea, vomiting, gut diseases, swallowing issues, or major bowel surgery.
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My heart health meets the study's requirements.
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I have not had a heart attack or stroke in the last 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
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
Assess frequency and severity of adverse events
Disease control rate (DCR)
Objective Response Rate (ORR)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Arm B (Osimertinib)Active Control1 Intervention
Osimertinib
Group II: Arm A (Osimertinib and Ramucirumab)Active Control2 Interventions
Osimertinib and Ramucirumab
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyIndustry Sponsor
2,675 Previous Clinical Trials
3,463,823 Total Patients Enrolled
Xiuning LeLead Sponsor
M.D. Anderson Cancer CenterOTHER
3,068 Previous Clinical Trials
1,802,519 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your platelet count should be at least 100,000 per cubic millimeter.I have had a GI perforation or am at risk for one in the last 6 months.My brain metastases are stable, treated, or symptom-free, and I'm on low or no steroids.My high blood pressure has not been controlled with medication for over 4 weeks.I have had severe GI bleeding in the last 3 months.My spinal cord compression is stable or I have no symptoms.I cannot stop taking certain medications that affect my body's enzyme levels or heart rhythm.Your SGOT and SGPT levels are not more than three times the upper limit of normal, unless you have liver metastasis.My urine protein levels are low enough to meet the trial's requirements.I have severe liver disease with complications like confusion or fluid in my abdomen.I am 18 years old or older.I am a woman who can have children and have a recent negative pregnancy test.My cancer has spread and cannot be cured with surgery or radiation.I have been treated with EGFR inhibitors like erlotinib or osimertinib.I have had a serious blood clot, excluding minor ones, in the last 3 months.Your heart's electrical activity, measured as the QT interval, is longer than 470 milliseconds when you are resting.My lung cancer has a specific genetic change (EGFR Exon 19 deletion).My NSCLC has the EGFR L858R mutation, confirmed by a certified test.I don't have severe side effects from past treatments, except for possible hair loss.I am fully active or can carry out light work.Your hemoglobin level is at least 9 grams per deciliter.I agree to use birth control as required if I can have children or if I am a man not sterilized and with a partner who can have children.I have not coughed up blood or have a tumor invading major blood vessels.I have been treated with medications like bevacizumab or similar.Your bilirubin levels in the blood should not be too high, unless you have a specific condition called Gilbert Syndrome, in which case slightly higher levels are acceptable.I have not had major surgery in the last 28 days or minor surgery in the last 7 days, and I do not plan to have major surgery during the trial.My lung cancer is non-squamous and confirmed by lab tests.You have abnormal heart rhythms or patterns on your resting ECG.I have an eye condition that hasn't been diagnosed.I have not had a serious wound, ulcer, or bone fracture in the last 28 days.I haven't had cancer in the last 2 years, except for certain skin, cervical, prostate, or thyroid cancers.I do not have severe illnesses or infections that could affect my trial participation.My blood clotting levels are within safe limits and I have been on a stable dose of blood thinners for at least 14 days without recent bleeding.I have had lung conditions like ILD or radiation pneumonitis that needed steroids.My blood, liver, and kidney functions are all within normal ranges.I have conditions or take medications that could affect my heart's rhythm.You have had a bad reaction to osimertinib or ramucirumab in the past.I cannot take osimertinib due to severe nausea, vomiting, gut diseases, swallowing issues, or major bowel surgery.My heart health meets the study's requirements.You have a disease that can be measured according to specific guidelines.Your absolute neutrophil count is at least 1,500 per cubic millimeter.I have not had a heart attack or stroke in the last 6 months.I have had chemotherapy or immunotherapy before.My kidney function, measured by creatinine levels or clearance, is within the required range.My liver enzymes are within acceptable limits, even with liver metastasis.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (Osimertinib)
- Group 2: Arm A (Osimertinib and Ramucirumab)
Awards:
This trial has 1 awards, including:- 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.
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