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Tyrosine Kinase Inhibitor
AZD9291 Combinations for Non-Small Cell Lung Cancer
Phase 1
Waitlist Available
Led By Pasi A Jänne, MD, PhD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up confirmed during the fup period and at least every 12 weeks until the data cut-off for the primary analysis and determination that no further os collection is needed, approximately 5 years, death, or full withdrawal of consent, whichever comes first.
Awards & highlights
Summary
This trial is testing a new lung cancer drug, given with another cancer drug or selumetinib, to see if it is safe and works well against cancer.
Who is the study for?
Adults with advanced lung cancer and specific EGFR mutations who've seen their disease progress on previous EGFR TKI treatments like gefitinib or erlotinib. They must have at least one measurable lesion, be able to take oral meds, and have good organ function. Pregnant women, those with certain heart conditions or active infections, and patients recently on other cancer therapies are excluded.
What is being tested?
The trial is testing the safety and effectiveness of AZD9291 in combination with other drugs (AZD6094 or selumetinib) for treating advanced lung cancer. It's exploring different combinations to see which works best against tumors that have a particular mutation making them resistant to standard treatments.
What are the potential side effects?
Potential side effects may include issues related to drug sensitivity such as allergic reactions, problems from the drugs affecting organs differently than intended, gastrointestinal disturbances due to oral medication intake, blood disorders from bone marrow involvement, and possibly increased risk of infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ confirmed during the fup period and at least every 12 weeks until the data cut-off for the primary analysis and determination that no further os collection is needed, approximately 5 years, death, or full withdrawal of consent, whichever comes first.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~confirmed during the fup period and at least every 12 weeks until the data cut-off for the primary analysis and determination that no further os collection is needed, approximately 5 years, death, or full withdrawal of consent, whichever comes first.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with Adverse Events and/or Dose Limiting Toxicities as a Measure of Safety and Tolerability of AZD9291 when given in combination with AZD6094 or selumetinib
Number of participants with Adverse Events as a measure of Safety and Tolerability of AZD9291 when given in combination with AZD6094 or selumetinib
Secondary study objectives
AUC after single dosing
AUC0-24 after single dosing
AUC0-t after single dosing
+18 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: SelumetinibExperimental Treatment4 Interventions
AZD9291 in combination with selumetinib
Group II: MEDI4736Experimental Treatment2 Interventions
AZD9291 in combination with MEDI4736. Enrolment into the patient cohort that evaluated AZD9291 treatment in combination with MEDI4736 as 1st line treatment has been terminated due to an increased incidence of ILD-like events (interstitial lung disease/pneumonitis), and is no longer being evaluated in this study.
Group III: AZD6094 (monotherapy)Experimental Treatment1 Intervention
AZD6094 in monotherapy (for Japan only)
Group IV: AZD6094Experimental Treatment4 Interventions
AZD9291 in combination with AZD6094
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Who is running the clinical trial?
AstraZenecaLead Sponsor
4,352 Previous Clinical Trials
288,646,465 Total Patients Enrolled
Pasi A Jänne, MD, PhDPrincipal InvestigatorDana-Faber Cancer Institute
2 Previous Clinical Trials
530 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have stomach or intestine problems affecting medication absorption.I am not taking any strong CYP3A4 inducers for the last 3 weeks.I have previously been treated with a specific type of lung cancer medication.I have previously received AZD9291 in this study.I am currently on warfarin or low molecular weight heparin.I haven't had major surgery or significant injury in the last 4 weeks and don't expect to need major surgery during the study.I've had targeted radiation for symptom relief within a week before starting the study, not affecting more than 30% of my bone marrow.I have been treated with a cMET inhibitor if I am to receive AZD9291 and AZD6094.I am currently pregnant or breastfeeding.I have had a bone marrow transplant from another person.My lung cancer has a specific EGFR mutation.I have not had serious heart problems like heart failure or a stroke in the last 6 months.My blood pressure is high (over 150/95) even with medication.My heart's electrical cycle is longer than normal or I have risk factors for it.You have any important irregularities in your heart's electrical activity, like certain types of heart block or prolonged PR interval on an ECG.I haven't had treatment for another invasive cancer in the last 5 years, except for early-stage or non-invasive cancers.I am 18 years old or older.My cancer progressed despite treatment with drugs like gefitinib or erlotinib.My blood, liver, kidney, and clotting tests are all within normal ranges.My tumor has an EGFR mutation sensitive to certain treatments.My tumor's T790M status was confirmed locally with an approved test.I have a measurable tumor that has not been treated or biopsied recently.My tumor's cMET status was confirmed locally before joining the study.I haven't taken EGFR inhibitors like erlotinib or gefitinib in the last 8-10 days.I have hepatitis B or C but meet the specific conditions for treatment or have resolved the infection.I haven't taken any cancer drugs for my advanced lung cancer in the last 14 days.You are allergic to any of the ingredients in AZD6094.I do not have an active serious infection like TB or HIV.I can swallow and keep down pills.I am fully active or able to carry out light work.I am from Japan and at least 20 years old.
Research Study Groups:
This trial has the following groups:- Group 1: MEDI4736
- Group 2: AZD6094
- Group 3: AZD6094 (monotherapy)
- Group 4: Selumetinib
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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