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

April 17, 2024 updated by: AstraZeneca

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Research Site
      • Hong Kong, Hong Kong, 150001
        • Recruiting
        • Research Site
  • Italy
      • Avellino, Italy, 83100
        • Recruiting
        • Research Site
      • Bergamo, Italy, 24127
        • Recruiting
        • Research Site
      • Brescia, Italy, 25123
        • Recruiting
        • Research Site
      • Lecce, Italy, 73100
        • Recruiting
        • Research Site
      • Lecco, Italy, 23900
        • Recruiting
        • Research Site
      • Milano, Italy, 20141
        • Recruiting
        • Research Site
      • Napoli, Italy, 80131
        • Recruiting
        • Research Site
      • Palermo, Italy, 90146
        • Recruiting
        • Research Site
      • Peschiera Del Garda, Italy, 37019
        • Recruiting
        • Research Site
      • Reggio Emilia, Italy, 42123
        • Recruiting
        • Research Site
      • Sondrio, Italy, 23100
        • Recruiting
        • Research Site
      • Terni, Italy, 05100
        • Recruiting
        • Research Site
      • Udine, Italy, 33100
        • Recruiting
        • Research Site
  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • Recruiting
        • Research Site
      • Busan, Korea, Republic of, 48108
        • Recruiting
        • Research Site
      • Cheongju-si, Korea, Republic of, 28644
        • Recruiting
        • Research Site
      • Daejeon, Korea, Republic of, 35015
        • Recruiting
        • Research Site
      • Goyang-si, Korea, Republic of, 410-769
        • Recruiting
        • Research Site
      • Gyeonggi-do, Korea, Republic of, 13620
        • Recruiting
        • Research Site
      • Incheon, Korea, Republic of, 21565
        • Recruiting
        • Research Site
      • Seongnam-si, Korea, Republic of, 13496
        • Recruiting
        • Research Site
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Research Site
      • Seoul, Korea, Republic of, 05505
        • Recruiting
        • Research Site
      • Seoul, Korea, Republic of, 06591
        • Recruiting
        • Research Site
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Research Site
      • Seoul, Korea, Republic of, 05030
        • Recruiting
        • Research Site
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Research Site
      • Seoul, Korea, Republic of, 06273
        • Recruiting
        • Research Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Recruiting
        • Research Site
      • Kuantan, Malaysia, 25100
        • Recruiting
        • Research Site
      • Kuching, Malaysia, 93586
        • Recruiting
        • Research Site
      • Petaling Jaya, Malaysia, 47500
        • Recruiting
        • Research Site
      • Sungai Petani, Malaysia, 08000
        • Withdrawn
        • Research Site
  • Philippines
      • Bacolod, Philippines, 6100
        • Recruiting
        • Research Site
      • Cebu, Philippines, 6000
        • Recruiting
        • Research Site
      • Manila, Philippines, 1000
        • Recruiting
        • Research Site
      • Quezon City, Philippines, 1100
        • Recruiting
        • Research Site
  • Singapore
      • Singapore, Singapore, 119074
        • Recruiting
        • Research Site
  • Spain
      • Badalona, Spain, 08013
        • Recruiting
        • Research Site
      • Barcelona, Spain, 08036
        • Recruiting
        • Research Site
      • Bilbao, Spain, 48013
        • Recruiting
        • Research Site
      • Granada, Spain, 18014
        • Recruiting
        • Research Site
      • L'Hospitalet de Llobregat, Spain, 08907
        • Recruiting
        • Research Site
      • Madrid, Spain, 28007
        • Recruiting
        • Research Site
      • Sevilla, Spain, 41009
        • Recruiting
        • Research Site
      • Valencia, Spain, 46026
        • Recruiting
        • Research Site
  • Taiwan
      • Hualien, Taiwan, 970
        • Recruiting
        • Research Site
      • Kaohsiung, Taiwan, 82445
        • Recruiting
        • Research Site
      • Kaohsiung City, Taiwan, 833401
        • Recruiting
        • Research Site
      • Taichung, Taiwan, 40705
        • Recruiting
        • Research Site
      • Taipei, Taiwan, 10449
        • Recruiting
        • Research Site
      • Taipei, Taiwan, 11259
        • Recruiting
        • Research Site
  • Thailand
      • Bangkok, Thailand, 10700
        • Recruiting
        • Research Site
      • Phitsanulok, Thailand, 65000
        • Withdrawn
        • Research Site
      • Songkhla, Thailand, 90110
        • Recruiting
        • Research Site
  • United Kingdom
      • Guildford, United Kingdom
        • Withdrawn
        • Research Site
      • London, United Kingdom, SW3 6JJ
        • Recruiting
        • Research Site
      • London, United Kingdom, W12 0HS
        • Withdrawn
        • Research Site
      • Nottingham, United Kingdom, NG5 1PB
        • Recruiting
        • Research Site
      • Surrey, United Kingdom, SM2 5PT
        • Recruiting
        • Research Site
  • United States
    • Arizona
      • Yuma, Arizona, United States, 85364
        • Recruiting
        • Research Site
    • California
      • Los Angeles, California, United States, 90095
        • Withdrawn
        • Research Site
      • Santa Rosa, California, United States, 95403
        • Recruiting
        • Research Site
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Recruiting
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Recruiting
        • Research Site
    • New York
      • White Plains, New York, United States, 10601
        • Recruiting
        • Research Site
    • Virginia
      • Fort Belvoir, Virginia, United States, 22060
        • Withdrawn
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female aged at least 18 years.
  2. Histologically confirmed diagnosis of primary NSCLC on predominantly non-squamous histology.
  3. Magnetic Resonance Imaging (MRI) or contrast computed tomography (CT) scan of the brain.
  4. Participants must be classified post-operatively as Stage II, IIIA, or IIIB on the basis of surgical pathologic criteria.
  5. 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).
  6. 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.
  7. Complete recovery from surgery and standard post-operative therapy (if applicable) at start of study intervention.
  8. World Health Organisation Performance Status of 0 to 1.
  9. 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.
  10. Male participants must use effective barrier contraception.

Exclusion Criteria:

  1. Major surgery (including primary tumour surgery, excluding placement of vascular access) within 4 weeks prior to the first dose of study drug.
  2. Participants currently receiving medications or herbal supplements known to be potent inducers of CYP3A4 (at least 3 weeks prior to first dose).
  3. Participants who have had only segmentectomies or wedge resections.
  4. 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 following the end of study intervention.

  5. Treatment with any of the following:

    • Pre-operative or post-operative or planned radiation therapy for the current lung cancer.
    • Pre-operative (neo-adjuvant) platinum-based or other chemotherapy.
    • Any prior anticancer 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).
  6. 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.

  7. 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).
  8. Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD.
  9. Inadequate bone marrow reserve or organ function.
  10. Women who are breastfeeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Osimertinib
Participants will receive osimertinib (AZD9291).
Drug: Osimertinib 80 mg/40 mg
Participants will receive osimertinib (80 mg or 40 mg orally, once daily).
Other Names:
  • AZD9291

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess 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.
Defined as time from date of first dose until disease recurrence, or death due to any cause in the absence of recurrence.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Free Survival Rate at 3, 4 and 5 Years (Uncommon 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 3 years, 4 years, and 5 years.
Defined as the proportion of participants alive and disease free at 3, 4, and 5 years.
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.
DFS Rate at 3 and 4 Years (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 3 years, and 4 years.
Defined as the proportion of participants alive and disease free at 3, and 4 years.
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.
Overall Survival (OS) [Common EGFRm Cohort]
Time Frame: 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.
Defined as time from date of first dose until the date of death due to any cause.
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.
Safety and tolerability in overall population (Common EGFRm Cohort and Uncommon EGFRm Cohort)
Time Frame: From date of first dose up to approximately 5 years
Adverse Events (AEs) graded by CTCAE version 5.0.
From date of first dose up to approximately 5 years
Recurrence events in overall population (Common EGFRm Cohort and Uncommon EGFRm Cohort)
Time Frame: From date of first dose up to approximately 5 years
Local/regional, or distant recurrence events assessed.
From date of first dose up to approximately 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2023

Primary Completion (Estimated)

April 5, 2029

Study Completion (Estimated)

April 5, 2029

Study Registration Dates

First Submitted

September 1, 2022

First Submitted That Met QC Criteria

September 1, 2022

First Posted (Actual)

September 2, 2022

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5162C00048
  • 2021-003024-33 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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