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Tyrosine Kinase Inhibitor

AZD9291 for Non-Small Cell Lung Cancer (CAURAL Trial)

Phase 3
Waitlist Available
Led By Leora Horn, MD
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 from baseline up to 3 months after the last dose (up to 24 months).
Awards & highlights

CAURAL Trial Summary

This trial is testing a new drug (AZD9291) to see if it is more effective than existing treatments for a specific type of lung cancer.

CAURAL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to 3 months after the last dose (up to 24 months).
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to 3 months after the last dose (up to 24 months). 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 Subjects With Adverse Events (AEs) as a Measure of the Safety and Tolerability of Osimertinib in Combination With Durvalumab

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%
Rhinorrhoea
18%
Back pain
18%
Productive cough
18%
Nausea
18%
Upper respiratory tract infection
18%
Neutrophil count decreased
18%
Dry skin
18%
Constipation
18%
Pneumonia
12%
Musculoskeletal chest pain
12%
Electrocardiogram QT prolonged
12%
Lung infection
12%
Aspartate aminotransferase increased
12%
Vomiting
12%
Alanine aminotransferase increased
12%
Decreased appetite
12%
Dizziness
12%
Dysphonia
12%
Epistaxis
12%
Rash maculo-papular
6%
Fatigue
6%
Blepharospasm
6%
Orthostatic hypotension
6%
Blepharitis
6%
Catheter site injury
6%
Tinnitus
6%
Hypoaesthesia
6%
Pain of skin
6%
Joint swelling
6%
Insomnia
6%
Hypoacusis
6%
Spontaneous haemorrhage
6%
Ear discomfort
6%
Gastroenteritis
6%
Sinus congestion
6%
Complication associated with device
6%
Asthenia
6%
Hypertension
6%
Anxiety
6%
Anaemia
6%
Onychoclasis
6%
Headache
6%
Ocular hyperaemia
6%
Epigastric discomfort
6%
Gastritis
6%
Mouth ulceration
6%
Ligament sprain
6%
Muscle spasms
6%
Osteoarthritis
6%
Renal vein embolism
6%
Urinary incontinence
6%
Uterine mass
6%
Laryngeal haemorrhage
6%
Rash macular
6%
Organising pneumonia
6%
Hot flush
6%
Dry eye
6%
Eyelid pain
6%
Retinal drusen
6%
Abdominal pain
6%
Flatulence
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%
Osteoporosis
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%
Milia
6%
Palmar-plantar erythrodysaesthesia syndrome
6%
Pruritus generalised
6%
Rash
6%
Skin fissures
6%
Urticaria
6%
Xanthelasma
6%
Urinary tract infection
6%
Pyrexia
6%
Colorectal cancer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Osimertinib 80 mg
Osimertinib 80 mg + Durvalumab 10 mg/kg

CAURAL Trial Design

2Treatment groups
Experimental Treatment
Group I: MEDI4736 & AZD9291 CombinationExperimental Treatment2 Interventions
10mg/kg q2w (IV) infusion & once daily tablet 80 mg
Group II: AZD9291 MonotherapyExperimental Treatment1 Intervention
Once daily tablet 80 mg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD9291
2014
Completed Phase 3
~1100
MEDI4736
2016
Completed Phase 3
~5560

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,256 Previous Clinical Trials
288,593,421 Total Patients Enrolled
Leora Horn, MDPrincipal InvestigatorVanderbilt University, Nashville, USA
3 Previous Clinical Trials
161 Total Patients Enrolled
James CH Yang, MDPrincipal InvestigatorNational Taiwan University Hospital, Taiwan

Frequently Asked Questions

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

Are there any precedents for the clinical trial we are discussing involving AZD9291?

"There are 440 clinical trials investigating AZD9291. 67 of those active clinical trials are in Phase 3. The many studies for AZD9291 are based in Wakayama-shi, Texas, but there are 17509 locations running trials for this treatment."

Answered by AI

Are researchers looking for participants for this clinical trial right now?

"The clinicaltrials.gov website reveals that this trial is not looking for new patients at the moment. This particular trial was first posted on July 15th, 2015 and updated last on August 31st, 2022. That being said, there are 441 other trials that are enrolling patients as we speak."

Answered by AI

What is the status of AZD9291 in the United States?

"This particular medication, AZD9291, is in Phase 3 of clinical trials. This means that while there is data supporting its efficacy, multiple rounds of data are needed to support its safety. Therefore, our team has given it a score of 3."

Answered by AI

What indications does AZD9291 typically address?

"AZD9291 is commonly used to treat unresectable stage iii non-small cell lung cancer. Additionally, this medication can be used to fight other forms of cancer such as metastatic ureter urothelial carcinoma."

Answered by AI

Is this a clinical trial that is open to anyone who meets the qualifications?

"The requirements for patients that wish to take part in this study are that they must have non-small cell lung carcinoma and be between 18 and 130 years old. The trial is currently looking for around 29 more patients."

Answered by AI

Could adolescents potentially benefit from this medication research?

"This particular clinical trial is only for adults aged 18 to 130. There are 6 other trials for patients that are younger and 440 trials for patients that are older."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of AZD9291 Plus MEDI4736 Versus AZD9291 Monotherapy in NSCLC After Previous EGFR TKI Therapy in T790M Mutation Positive Tumours
2015. "Study of AZD9291 Plus MEDI4736 Versus AZD9291 Monotherapy in NSCLC After Previous EGFR TKI Therapy in T790M Mutation Positive Tumours". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02454933.
~3 spots leftby Apr 2025
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