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Tyrosine Kinase Inhibitor
AZD9291 for Lung Cancer (AURA Trial)
Phase 1 & 2
Waitlist Available
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 recist tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 25 months (at time of analysis)
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a new drug on patients with NSCLC who have already tried other treatments. They will look at side effects, how much of the drug is in the body, and how well it works against the cancer.
Who is the study for?
This trial is for adults with advanced Non-Small Cell Lung Cancer (NSCLC) who have seen their tumor grow after at least one anti-cancer treatment. They must have benefited from EGFR TKI therapy, not be on certain treatments recently, and women must test negative for pregnancy and use contraception. Men should agree to barrier contraception.
What is being tested?
The study tests AZD9291 in patients with NSCLC for the first time to find the best dose for future trials. It will look at side effects, how much drug stays in the body, and its effectiveness against cancer.
What are the potential side effects?
Since this is the first trial of AZD9291 in humans, exact side effects are unknown but may include typical reactions to cancer drugs such as nausea, fatigue, skin issues or potential lung problems based on related treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ recist tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 25 months (at time of analysis)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~recist tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 25 months (at time of analysis)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Best Objective Response (BOR) for Dose Escalation Population
Objective Response Rate (ORR) for Dose Expansion Population
Objective Response Rate (ORR) for Extension Population
Secondary study objectives
Best Objective Response (BOR) for 80mg AZD9291 Extension Population
Duration of Response (DoR) for Dose Expansion Population
Progression-Free Survival (PFS) for Dose Expansion Population
Side effects data
From 2023 Phase 3 trial • 29 Patients • NCT0245493347%
Diarrhoea
41%
Paronychia
41%
Dermatitis acneiform
29%
Stomatitis
29%
Arthralgia
24%
Viral upper respiratory tract infection
24%
Cough
24%
Neutropenia
24%
Dyspnoea
24%
Pruritus
18%
Back pain
18%
Productive cough
18%
Rhinorrhoea
18%
Nausea
18%
Upper respiratory tract infection
18%
Neutrophil count decreased
18%
Dry skin
18%
Constipation
18%
Pneumonia
12%
Electrocardiogram QT prolonged
12%
Aspartate aminotransferase increased
12%
Vomiting
12%
Lung infection
12%
Musculoskeletal chest pain
12%
Alanine aminotransferase increased
12%
Decreased appetite
12%
Dizziness
12%
Dysphonia
12%
Epistaxis
12%
Rash maculo-papular
6%
Osteoporosis
6%
Colorectal cancer
6%
Tinnitus
6%
Flatulence
6%
Epigastric discomfort
6%
Hypertension
6%
Orthostatic hypotension
6%
Anaemia
6%
Spontaneous haemorrhage
6%
Ear discomfort
6%
Blepharitis
6%
Ocular hyperaemia
6%
Hypoacusis
6%
Blepharospasm
6%
Mouth ulceration
6%
Fatigue
6%
Gastritis
6%
Asthenia
6%
Catheter site injury
6%
Complication associated with device
6%
Gastroenteritis
6%
Ligament sprain
6%
Joint swelling
6%
Muscle spasms
6%
Osteoarthritis
6%
Headache
6%
Hypoaesthesia
6%
Anxiety
6%
Insomnia
6%
Renal vein embolism
6%
Urinary incontinence
6%
Milia
6%
Uterine mass
6%
Laryngeal haemorrhage
6%
Organising pneumonia
6%
Sinus congestion
6%
Onychoclasis
6%
Pain of skin
6%
Pruritus generalised
6%
Rash macular
6%
Hot flush
6%
Dry eye
6%
Eyelid pain
6%
Retinal drusen
6%
Abdominal pain
6%
Oesophageal pain
6%
Toothache
6%
Pain
6%
Seasonal allergy
6%
Atypical pneumonia
6%
Cystitis
6%
Influenza
6%
Lower respiratory tract infection
6%
Oral candidiasis
6%
Sinusitis
6%
Avulsion fracture
6%
Fall
6%
Urine analysis abnormal
6%
Bone pain
6%
Musculoskeletal pain
6%
Pain in extremity
6%
Amnesia
6%
Paraesthesia
6%
Vaginal haemorrhage
6%
Nasal congestion
6%
Pleural effusion
6%
Sneezing
6%
Eczema asteatotic
6%
Intertrigo
6%
Palmar-plantar erythrodysaesthesia syndrome
6%
Rash
6%
Skin fissures
6%
Urticaria
6%
Xanthelasma
6%
Urinary tract infection
6%
Pyrexia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Osimertinib 80 mg
Osimertinib 80 mg + Durvalumab 10 mg/kg
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Daily dose of AZD9291Experimental Treatment1 Intervention
Daily oral dose of AZD9291
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD9291
2014
Completed Phase 3
~1100
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,412 Previous Clinical Trials
289,124,177 Total Patients Enrolled
Yuri RukazenkovStudy DirectorAstraZeneca
3 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have taken erlotinib or gefitinib within the last 8 days.You must have tried a specific medication for a certain type of gene mutation and shown improvement, but then your condition got worse even with continued treatment.You have severe or uncontrolled systemic diseases, such as uncontrolled high blood pressure, active bleeding tendencies, or active infection.You have not received any chemotherapy or other cancer medications for at least 14 days before starting the study treatment.You need to have a T790M mutation test done before you can join the study.You have taken AZD9291 in this study before.You have been treated before with a specific type of medication called EGFR TKI, like gefitinib or erlotinib.If you are in the dose expansion or extension groups, you need to have a biopsy to check for a specific T790M mutation in your tumor after your most recent treatment stopped working.Your disease got worse on a previous treatment with certain medications, and you have tried other treatments that did not work.Your tumor has a specific mutation that can be treated with a type of medication called EGFR TKI.For a specific group of participants, it is required that their cancer has a certain mutation and they have not received any treatment before for their advanced cancer.You have been diagnosed with Non Small Cell Lung Cancer through a tissue or fluid sample.You have a history of lung disease or have lung problems that need treatment with steroids.You are feeling well and able to carry out your normal activities, and your doctor expects you to live for at least 12 more weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Daily dose of AZD9291
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.