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AZD9291 Combinations for Non-Small Cell Lung Cancer
Study 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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- 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.
- Group 1: MEDI4736
- Group 2: AZD6094
- Group 3: AZD6094 (monotherapy)
- Group 4: Selumetinib
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is recruitment still underway for this experiment?
"This experiment has concluded and is no longer recruiting participants. Originally posted on August 5th 2014, this trial was last modified on October 12th 2022. Nonetheless, there are still 1367 medical tests actively enrolling patients with advanced non small cell lung cancer (nsclc) and 463 studies searching for participants to join Part A - AZD9291 in combination with AZD6094."
Has this research ever been undertaken before?
"Currently, 463 active trials concerning Part A - AZD9291 in combination with AZD6094 are spread across 1630 cities and 60 different nations. The inaugural trial for this drug regimen was conducted in 2007 by AstraZeneca; it featured 58 participants and successfully completed Phase 1 of the FDA approval process. In total, 209 studies have been undertaken since then."
What are the ultimate objectives of this research endeavor?
"The primary purpose of this clinical trial is to assess the Safety and Tolerability of AZD9291 when given in combination with AZD6094 or selumetinib by collecting data on adverse events from baseline until 28 days after their last dose. Secondary objectives include characterizing the pharmacokinetics of all three drugs through AUC0-t, CL/f, and Cssmin measurements following single dosing and multiple dosing respectively."
What is the maximum capacity for participants in this experiment?
"Unfortunately, this trial is not enrolling new patients. The study was initially made public on August 5th 2014 and its latest update occurred October 12th 2022. If you are exploring other options, there are 1367 clinical trials actively recruiting participants with advanced non-small cell lung cancer (NSCLC) and 463 for Part A - AZD9291 in combination with AZD6094 still searching for volunteers.."
In which locations is this experiment being conducted?
"At the moment, patients can join this clinical trial at 7 different medical centres. The major cities that are covered include Calgary, Atlanta and Boston; other locations exist too. To reduce travel disruption it's advisable to choose a clinic nearby your residence when signing up for the study."
Are there reports detailing the efficacy of a dual therapy involving Part A - AZD9291 and AZD6094?
"Currently, there are 463 studies in progress related to the combination of Part A - AZD9291 and AZD6094. Of those trials, 76 have advanced to Phase 3 with most located in Cordoba, Texas. However, this treatment is also being tested at 19032 other sites globally."
Are there any upper-age restrictions to this experiment?
"This trial requires participants to be aged between 18 and 130 years old."
What is the current Food and Drug Administration status of Part A - AZD9291 combined with AZD6094?
"Our team at Power assigned a score of 1 for the safety and efficacy of AZD9291 in combination with AZD6094 due to limited clinical data. This is a Phase 1 trial."
What are the customary applications of Part A - AZD9291 in conjunction with AZD6094?
"Part A – AZD9291 combined with AZD6094 is an effective method of treating malignant neoplasms, neurofibroma, and advance directives."
Who is eligible to enroll in this research study?
"This study is recruiting 344 participants with advanced non small cell lung cancer (nsclc) aged between 18 and 130. Most importantly, candidates must fulfill the following criteria: Signed informed consent; Male or female patients of at least 18 years old from Japan aged above 20; Histological/cytological validation of EGFRm+ NSCLC plus confirmation that tumours harbor an EGFR mutation associated to TKI sensitivity; Radiological demonstration of disease progression while on prior continuous treatment with a TKI such as Gefitinib/Erlotinib; At least one lesion not previously irradiated, biopsied during screening"
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