What side effects are associated with this type of intervention?

Common treatments for lung carcinoma, particularly EGFR Tyrosine Kinase Inhibitors like Osimertinib, often have side effects including fatigue, nausea, diarrhea, and increased liver function tests. More severe adverse events can include cardiac issues, pulmonary hemorrhage, and skin reactions. Other treatments, such as chemotherapy combined with immunotherapy (e.g., pembrolizumab), can lead to additional side effects like sensory neuropathy, thrombocytopenia, and immune-related adverse events. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

Osimertinib is an FDA-approved EGFR tyrosine kinase inhibitor (TKI) used for the treatment of non-small cell lung cancer (NSCLC) with specific EGFR mutations. Other FDA-approved EGFR TKIs for NSCLC include erlotinib, gefitinib, and afatinib. These drugs target mutations in the EGFR gene, which are common in a subset of NSCLC patients, particularly non-smokers and those with adenocarcinoma histology. These treatments have shown efficacy in improving progression-free survival and are integral in the personalized treatment approach for EGFR-mutated NSCLC.

What other types of research exist?

Promising novel alternatives to Osimertinib for lung carcinoma patients include Alectinib, Brigatinib, and Lorlatinib. These agents have shown efficacy in clinical trials for ALK-positive NSCLC and may offer benefits for patients with specific genetic mutations. Additionally, emerging treatments such as Selpercatinib and Cabozantinib, which target RET and MET alterations respectively, are also being investigated and may provide new options for patients with specific molecular profiles.

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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

Must not have

Participants who have had only segmentectomies or wedge resections

Any of the following cardiac criteria: Mean resting corrected QT (QTc) interval > 470 msec, obtained from 3 electrocardiograms (ECGs), Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG, Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, Heart failure, congenital long QT interval (QT) syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval and cause Torsades de Pointes (TdP)

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

No Placebo-Only Group

Summary

This trial is testing osimertinib, a lung cancer drug, in patients with specific genetic changes in their cancer. It aims to see if the drug can help prevent cancer from returning after surgery.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung cancer is mainly non-squamous based on tissue analysis.

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I can carry out all my usual activities without help.

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My cancer was classified as Stage II, IIIA, or IIIB after surgery.

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I have fully recovered from any surgery and its follow-up treatments.

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I will use effective barrier methods for birth control.

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My lung cancer was completely removed by surgery with no cancer cells at the edges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have only had minor lung surgery.

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I do not have any major heart issues or a family history of sudden heart-related deaths.

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I have had lung conditions that needed steroid treatment.

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My bone marrow or organs are not functioning well.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Estimate the Efficacy of Osimertinib as Measured by Disease Free Survival (DFS) [Common EGFRm Cohort].

Secondary study objectives

Heart rate

Disease Free Survival Rate at 3, 4 and 5 Years (Uncommon EGFRm Cohort)

Overall Survival (OS) [Common EGFRm Cohort]

+2 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

Osteoporosis

Colorectal cancer

Tinnitus

Flatulence

Epigastric discomfort

Hypertension

Orthostatic hypotension

Anaemia

Spontaneous haemorrhage

Ear discomfort

Blepharitis

Ocular hyperaemia

Hypoacusis

Blepharospasm

Mouth ulceration

Fatigue

Gastritis

Asthenia

Catheter site injury

Complication associated with device

Gastroenteritis

Ligament sprain

Joint swelling

Muscle spasms

Osteoarthritis

Headache

Hypoaesthesia

Anxiety

Insomnia

Renal vein embolism

Urinary incontinence

Milia

Uterine mass

Laryngeal haemorrhage

Organising pneumonia

Sinus congestion

Onychoclasis

Pain of skin

Pruritus generalised

Rash macular

Hot flush

Dry eye

Eyelid pain

Retinal drusen

Abdominal pain

Oesophageal pain

Toothache

Pain

Seasonal allergy

Atypical pneumonia

Cystitis

Influenza

Lower respiratory tract infection

Oral candidiasis

Sinusitis

Avulsion fracture

Fall

Urine analysis abnormal

Bone pain

Musculoskeletal pain

Pain in extremity

Amnesia

Paraesthesia

Vaginal haemorrhage

Nasal congestion

Pleural effusion

Sneezing

Eczema asteatotic

Intertrigo

Palmar-plantar erythrodysaesthesia syndrome

Rash

Skin fissures

Urticaria

Xanthelasma

Urinary tract infection

Pyrexia

100%

80%

60%

40%

20%

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: OsimertinibExperimental Treatment1 Intervention

Participants will receive osimertinib (AZD9291).

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for lung carcinoma, particularly non-small cell lung cancer (NSCLC) with EGFR mutations, include EGFR tyrosine kinase inhibitors (TKIs) like Osimertinib. These inhibitors work by blocking the activity of the EGFR protein, which is often mutated and overactive in NSCLC, leading to uncontrolled cell growth. By inhibiting EGFR, these drugs can reduce tumor growth and spread. This is crucial for lung carcinoma patients as it offers a targeted approach that can be more effective and have fewer side effects compared to traditional chemotherapy. Other treatments include monoclonal antibodies like cetuximab, which also target the EGFR pathway, and immunotherapies that enhance the body's immune response against cancer cells. These targeted therapies are significant because they provide personalized treatment options based on the genetic profile of the tumor, potentially improving outcomes and quality of life for patients.

New targeted treatments in lung cancer--overview of clinical trials.