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Stage II-IIIB Non-small Cell Lung CarcinomaPhase 2TARGETNCT05526755

A Study of 5 Years of Adjuvant Osimertinib in Completely Resected Epidermal Growth Factor Receptor Mutation (EGFRm) Non-small Cell Lung Carcinoma (NSCLC)

A Phase 2 study testing Osimertinib 80 mg/40 mg in people with Stage II-IIIB Non-small Cell Lung Carcinoma, run by AstraZeneca at 56 sites in 11 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

To assess the efficacy and safety of osimertinib in participants with EGFRm positive stage II-IIIB NSCLC, following complete tumour resection with or without adjuvant chemotherapy. Read more about this study

Who is it for?
Ages 18 to 130 years
What is being tested?
Osimertinib 80 mg/40 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
188 participants
Where
56 sitesin 11 countries
Study dates
6 Mar 2023to 22 Nov 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 130 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female aged at least 18 years.
  • Histologically confirmed diagnosis of primary NSCLC on predominantly non-squamous histology.
  • Magnetic Resonance Imaging (MRI) or contrast computed tomography (CT) scan of the brain.
  • Participants must be classified post-operatively as Stage II, IIIA, or IIIB on the basis of surgical pathologic criteria.
  • Confirmation by the local laboratory that the tumour harbours one of the two common EGFR mutations (Ex19del, L858R), either alone or in combination with other EGFR mutations including de novo EGFR mutation resulting in substitution of threonine with methionine at amino acid position 790 in exon 20 of EGFR (T790M) or uncommon EGFR mutations G719X, S768I, and L861Q, either alone, in combination with each other, or in combination with other uncommon EGFR mutations (excluding all exon 20 insertions) (Uncommon EGFRm Cohort).
  • Complete surgical resection of the primary NSCLC is mandatory. All gross disease must have been removed at the end of surgery. All surgical margins of resection must be negative for tumour.
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  • Complete recovery from surgery and standard post-operative therapy (if applicable) at start of study intervention.
  • World Health Organisation Performance Status of 0 to 1.
  • Female participants must be using highly effective contraceptive measures, and must have a negative pregnancy test prior to start of dosing if of childbearing potential.
  • Male participants must use effective barrier contraception.

Who cannot join

  • Major surgery (including primary tumour surgery, excluding placement of vascular access) within 4 weeks prior to the first dose of study drug.
  • Participants currently receiving medications or herbal supplements known to be strong inducers of CYP3A4 (at least 3 weeks prior to first dose).
  • Participants who have had only segmentectomies or wedge resections.
  • History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer, or other solid tumours curatively treated with no evidence of disease for > 5 years before the start of study intervention.
  • Treatment with any of the following:
  • Pre-operative or post-operative or planned radiation therapy for the current lung cancer.
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  • Pre-operative (neo-adjuvant) platinum-based or other chemotherapy.
  • Any prior anti-cancer or immunological therapy, including investigational therapy, for treatment of NSCLC other than standard platinum-based doublet post-operative adjuvant chemotherapy.
  • Prior treatment with neoadjuvant or adjuvant EGFR tyrosine kinase inhibitor (TKI).
  • Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of osimertinib.
  • 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).
  • Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD.
  • Inadequate bone marrow reserve or organ function.
  • Women who are breastfeeding.

Trial locations and contacts

56 sites in 11 countries.

56 sites in 11 countries

South Korea15 sites

  • Research Site

    Busan, 48108

  • Research Site

    Busan, 49241

  • Research Site

    Cheongju-si, 28644

  • Research Site

    Daejeon, 35015

  • Research Site

    Goyang-si, 410-769

  • Research Site

    Gyeonggi-do, 13620

  • Research Site

    Incheon, 21565

  • Research Site

    Seongnam-si, 13496

  • Research Site

    Seoul, 03080

  • Research Site

    Seoul, 03722

  • Research Site

    Seoul, 05030

  • Research Site

    Seoul, 05505

  • Research Site

    Seoul, 06273

  • Research Site

    Seoul, 06351

  • Research Site

    Seoul, 06591

Other trials in South Korea

Italy11 sites

  • Research Site

    Avellino, 83100

  • Research Site

    Brescia, 25123

  • Research Site

    Lecce, 73100

  • Research Site

    Milan, 20141

  • Research Site

    Naples, 80131

  • Research Site

    Palermo, 90146

  • Research Site

    Peschiera del Garda, 37019

  • Research Site

    Reggio Emilia, 42123

  • Research Site

    Sondrio, 23100

  • Research Site

    Terni, 05100

  • Research Site

    Udine, 33100

Other trials in Italy

Spain8 sites

  • Research Site

    Badalona, 08013

  • Research Site

    Barcelona, 08036

  • Research Site

    Bilbao, 48013

  • Research Site

    Granada, 18014

  • Research Site

    L'Hospitalet de Llobregat, 08907

  • Research Site

    Madrid, 28007

  • Research Site

    Seville, 41009

  • Research Site

    Valencia, 46026

Other trials in Spain

Taiwan5 sites

  • Research Site

    Hualien City, 970

  • Research Site

    Kaohsiung City, 82445

  • Research Site

    Kaohsiung City, 833401

  • Research Site

    Taichung, 40705

  • Research Site

    Taipei, 10449

Other trials in Taiwan

United States3 sites

  • Research Site

    Las Vegas, Nevada, 89169

  • Research Site

    Santa Rosa, California, 95403

  • Research Site

    White Plains, New York, 10601

Other trials in United States

Hong Kong3 sites

  • Research Site

    Hong Kong, 150001

  • Research Site

    Hong Kong, 999077

  • Research Site

    Hong Kong

Other trials in Hong Kong

Malaysia3 sites

  • Research Site

    Kuala Lumpur, 59100

  • Research Site

    Kuantan, 25100

  • Research Site

    Kuching, 93586

Other trials in Malaysia

Philippines3 sites

  • Research Site

    Cebu, 6000

  • Research Site

    Manila, 1000

  • Research Site

    Quezon City, 1100

Other trials in Philippines

Thailand2 sites

  • Research Site

    Bangkok, 10700

  • Research Site

    Songkhla, 90110

Other trials in Thailand

United Kingdom2 sites

  • Research Site

    London, SW3 6JJ

  • Research Site

    Nottingham, NG5 1PB

Other trials in United Kingdom

Singapore1 site

  • Research Site

    Singapore, 119074

Other trials in Singapore

About this study

Official title: An Open-label, Single-arm, Phase II, Multinational, Multicentre Study to Assess the Efficacy and Safety of 5 Years of Osimertinib in Participants With EGFRm-positive Stage II-IIIB NSCLC, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy

To assess the efficacy and safety of osimertinib in participants with EGFRm positive stage II-IIIB NSCLC, following complete tumour resection with or without adjuvant chemotherapy.

Read the detailed description

This is a phase 2 open-label study to assess the efficacy and safety of osimertinib in participants with stage II-IIIB NSCLC with sensitising EGFR mutations. The study is designed to evaluate 5 years of adjuvant osimertinib therapy.

Being tested
Osimertinib 80 mg/40 mg
Keywords
Stage II-IIIB Non-small Cell Lung Cancer, Adjuvant osimertinib, Adjuvant chemotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Osimertinib 80 mg/40 mgDrug

    Also called AZD9291, TAGRISSO™

    Participants will receive osimertinib (80 mg or 40 mg orally, once daily).

Study groups in NCT05526755
Study groupRoleWhat they receive
OsimertinibExperimentalParticipants will receive osimertinib (AZD9291).
Receives: Drug: Osimertinib 80 mg/40 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Defined as time from date of first dose until disease recurrence, or death due to any cause in the absence of recurrence.

    Measured: 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 5 years.

Secondary outcomes (5)

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

    Defined as the proportion of participants alive and disease free at 3, 4, and 5 years.

    Measured: 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, 4 years, and 5 years.

  2. DFS Rate at 3 and 4 Years (Common EGFRm Cohort)

    Defined as the proportion of participants alive and disease free at 3, and 4 years.

    Measured: 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.

  3. Overall Survival (OS) [Common EGFRm Cohort]

    Defined as time from date of first dose until the date of death due to any cause.

    Measured: 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.

  4. Safety and tolerability in overall population (Common EGFRm Cohort and Uncommon EGFRm Cohort)

    Adverse Events (AEs) graded by CTCAE version 5.0.

    Measured: From date of first dose up to approximately 5 years

  5. Recurrence events in overall population (Common EGFRm Cohort and Uncommon EGFRm Cohort)

    Local/regional, or distant recurrence events assessed.

    Measured: From date of first dose up to approximately 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2022
  2. Study start6 Mar 2023
  3. Primary completion22 Nov 2029 (estimated)
  4. Study completion22 Nov 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
188 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05526755
Sponsor's protocol ID
D5162C00048
Other IDs
2023-508740-21-00, 2021-003024-33, 2023
Acronym
TARGET
Status last verified
Jul 2026
First submitted
1 Sep 2022
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual participant-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Publications

  • Soo RA, de Marinis F, Han JY, Ho JC, Martin E, Servidio L, Sandelin M, Popat S. TARGET: A Phase II, Open-Label, Single-Arm Study of 5-Year Adjuvant Osimertinib in Completely Resected EGFR-Mutated Stage II to IIIB NSCLC Post Complete Surgical Resection. Clin Lung Cancer. 2024 Jan;25(1):80-84. doi: 10.1016/j.cllc.2023.09.005. Epub 2023 Oct 4.

    PubMed 37914594

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Osimertinib 80 mg/40 mg in people with Stage II-IIIB Non-small Cell Lung Carcinoma, run by AstraZeneca at 56 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in South Korea, Italy, Spain, Taiwan, United States and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Estimate the Efficacy of Osimertinib as Measured by Disease Free Survival (DFS) [Common EGFRm Cohort]. (time frame: 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 5 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05526755, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

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