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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
Histological or cytological confirmation of EGFRm+ NSCLC
Male or female aged at least 18 years and older
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

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.

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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer has a specific EGFR mutation.
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I am 18 years old or older.
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My cancer progressed despite treatment with drugs like gefitinib or erlotinib.
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My blood, liver, kidney, and clotting tests are all within normal ranges.
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My tumor has an EGFR mutation sensitive to certain treatments.
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My tumor's T790M status was confirmed locally with an approved test.
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I have a measurable tumor that has not been treated or biopsied recently.
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My tumor's cMET status was confirmed locally before joining the study.
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I can swallow and keep down pills.
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I am fully active or able to carry out light work.
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I am from Japan and at least 20 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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
AUC after single dosing
AUC0-24 after single dosing
AUC0-t after single dosing
+18 more

Trial 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

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,238 Previous Clinical Trials
288,471,077 Total Patients Enrolled
Pasi A Jänne, MD, PhDPrincipal InvestigatorDana-Faber Cancer Institute
2 Previous Clinical Trials
530 Total Patients Enrolled

Media Library

AZD6094 (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02143466 — Phase 1
Non-Small Cell Lung Cancer Research Study Groups: MEDI4736, AZD6094, AZD6094 (monotherapy), Selumetinib
Non-Small Cell Lung Cancer Clinical Trial 2023: AZD6094 Highlights & Side Effects. Trial Name: NCT02143466 — Phase 1
AZD6094 (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02143466 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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.."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Are there any upper-age restrictions to this experiment?

"This trial requires participants to be aged between 18 and 130 years old."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI
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~33 spots leftby Mar 2025