Your session is about to expire
← Back to Search
Adjuvant Osimertinib for Lung Cancer (TARGET Trial)
Phase 2
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed diagnosis of primary NSCLC on predominantly non-squamous histology
World Health Organisation Performance Status of 0 to 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of first dose until the date of death due to any cause, up to approximately 5 years. assessed at 3 years, 4 years, and 5 years.
Awards & highlights
TARGET Trial Summary
This trial looks at how safe and effective a drug is for people with lung cancer after surgery and/or chemo.
Who is the study for?
Adults with a confirmed diagnosis of non-squamous NSCLC, who have had complete surgical removal of the tumor and are in stage II-IIIB. They must have specific EGFR mutations, be fully recovered from surgery, not pregnant or breastfeeding, using effective contraception if applicable, and without a history of certain heart conditions or other cancers.Check my eligibility
What is being tested?
The trial is testing the effectiveness and safety of osimertinib for patients with EGFRm positive stage II-IIIB NSCLC after full tumor resection. It may include those who've had adjuvant chemotherapy. The focus is on long-term outcomes over five years.See study design
What are the potential side effects?
Osimertinib can cause side effects like diarrhea, rashes, dry skin, nail changes, mouth sores; less commonly it might affect lung function (ILD), heart rhythm (QT prolongation), or liver enzymes.
TARGET Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is mainly non-squamous based on tissue analysis.
Select...
I can carry out all my usual activities without help.
Select...
My cancer was classified as Stage II, IIIA, or IIIB after surgery.
Select...
I have fully recovered from any surgery and its follow-up treatments.
Select...
I will use effective barrier methods for birth control.
Select...
My lung cancer was completely removed by surgery with no cancer cells at the edges.
TARGET Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of first dose until date of disease recurrence or death (by any cause in the absence of recurrence), up to approximately 5 years. assessed at 3 years, and 4 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of first dose until date of disease recurrence or death (by any cause in the absence of recurrence), up to approximately 5 years. assessed at 3 years, and 4 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assess the Efficacy of Osimertinib as Measured by Disease Free Survival (DFS) [Common EGFRm Cohort].
Secondary outcome measures
Heart rate
Disease Free Survival Rate at 3, 4 and 5 Years (Uncommon EGFRm Cohort)
Overall Survival (OS) [Common EGFRm Cohort]
+2 moreSide 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%
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%
Joint swelling
6%
Orthostatic hypotension
6%
Fatigue
6%
Blepharospasm
6%
Blepharitis
6%
Catheter site injury
6%
Tinnitus
6%
Hypoaesthesia
6%
Pain of skin
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
TARGET Trial Design
1Treatment groups
Experimental Treatment
Group I: OsimertinibExperimental Treatment1 Intervention
Participants will receive osimertinib (AZD9291).
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,272 Previous Clinical Trials
288,612,495 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can carry out all my usual activities without help.You have had a scan of your brain using MRI or contrast CT.I do not have any major heart issues or a family history of sudden heart-related deaths.I am not taking strong CYP3A4 inducers for the last 3 weeks.I have fully recovered from any surgery and its follow-up treatments.I have only had minor lung surgery.I will use effective barrier methods for birth control.My cancer was classified as Stage II, IIIA, or IIIB after surgery.My lung cancer is mainly non-squamous based on tissue analysis.I am 18 years old or older.My tumor has specific EGFR mutations.I have had cancer before, but it was either skin cancer treated well, a cancer that was removed completely, or any cancer that has not come back in over 5 years.I have not had major surgery in the last 4 weeks.I am using reliable birth control and not pregnant if I can have children.I have had lung conditions that needed steroid treatment.You have received certain types of treatments for lung cancer in the past, such as radiation therapy, chemotherapy, or specific medications. You also have certain digestive problems that may affect how well you can absorb the study drug.My lung cancer was completely removed by surgery with no cancer cells at the edges.My bone marrow or organs are not functioning well.
Research Study Groups:
This trial has the following groups:- Group 1: Osimertinib
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals over the age of 65 excluded from participating in this trial?
"This clinical trial is seeking participants who have attained the age of majority, yet are younger than 130 years old."
Answered by AI
Who is able to participate in this exploration?
"The eligibility criteria for this clinical trial necessitates a diagnosis of lung carcinoma, and the patient must be between 18-130 years old. Up to 180 participants are being accepted."
Answered by AI
What potential risks are associated with Osimertinib consumption?
"Our team at Power determined that osimertinib achieved a rating of 2 on the safety scale. This is due to Phase 2 trial data suggesting some level of security, but there being no evidence yet proving its efficacy."
Answered by AI
How many qualified persons are being enrolled in this experiment?
"Affirmative. According to the information on clinicaltrials.gov, this medical research began recruitment activities in March 6th 2021 and was last updated at the end of month. The study requires 180 volunteers from 54 different sites around the country."
Answered by AI
How many medical facilities are currently conducting this research?
"Currently, this study is hosted in 54 centres spread throughout the nation. These locations include Santa Rosa, Rockville and Fort Belvoir as well as other sites that may be closer to you. It is advised for participants to choose a site near them so they can minimize travel demands."
Answered by AI
Is this clinical research currently enrolling participants?
"Affirmative, the information hosted on clinicaltrials.gov implies that this medical experiment is currently seeking out individuals to partake in it. The trial was first made available on March 6th 2023 and has since been amended with its last update coming later on 28th of the same month. 180 participants are being sought from 54 distinct sites."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger