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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 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)
This trial's timeline: 3 weeks for screening, Varies for treatment, and recist tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 25 months (at time of analysis) for reporting.

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 • NCT02454933
47%
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

AZD9291 (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01802632 — Phase 1 & 2
Non-Small Cell Lung Cancer Research Study Groups: Daily dose of AZD9291
Non-Small Cell Lung Cancer Clinical Trial 2023: AZD9291 Highlights & Side Effects. Trial Name: NCT01802632 — Phase 1 & 2
AZD9291 (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01802632 — Phase 1 & 2
~47 spots leftby Dec 2025