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EGFR TKI

AZD9291 for Non-Small Cell Lung Cancer

Phase 1
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 blood samples collected on day 1 and day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post azd9291 dose in part a.
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if an antifungal medication, itraconazole, affects the effectiveness of a lung cancer drug, AZD9291, in patients whose cancer has not responded to standard treatments. Itraconazole has been studied for its potential anticancer effects.

Eligible Conditions
  • Lung Cancer
  • Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~blood samples collected on day 1 and day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post azd9291 dose in part a.
This trial's timeline: 3 weeks for screening, Varies for treatment, and blood samples collected on day 1 and day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post azd9291 dose in part a. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
AUC of AZD9291
Cmax of AZD9291
Secondary study objectives
AUC of AZ5104
AUC of AZ7550
AUC(0-120) of AZD9291
+7 more

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: AZD9291 alone, AZD9291+itraconozoleExperimental Treatment3 Interventions
Sequential treatments of AZD9291 alone followed by AZD9291+itraconazole, with a washout period in between.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD9291
2014
Completed Phase 3
~1100
Pharmacokinetic sampling
2014
Completed Phase 1
~300
Itraconazole
2017
Completed Phase 2
~830

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,397 Previous Clinical Trials
289,121,618 Total Patients Enrolled
Serban Ghiorghiu, MSDStudy DirectorAstraZeneca
5 Previous Clinical Trials
311 Total Patients Enrolled
~4 spots leftby Nov 2025
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