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

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ClinicalTrials.gov Identifier: NCT05526755
Recruitment Status : Recruiting
First Posted : September 2, 2022
Last Update Posted : April 18, 2024
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Stage II-IIIB Non-small Cell Lung Carcinoma Drug: Osimertinib 80 mg/40 mg Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 6, 2023
Estimated Primary Completion Date : April 5, 2029
Estimated Study Completion Date : April 5, 2029

Resource links provided by the National Library of Medicine

Drug Information available for: Osimertinib

Arms and Interventions
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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 Name: AZD9291


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05526755


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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Sponsors and Collaborators
AstraZeneca
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT05526755    
Other Study ID Numbers: D5162C00048
2021-003024-33 ( EudraCT Number )
First Posted: September 2, 2022    Key Record Dates
Last Update Posted: April 18, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
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.
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.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
Stage II-IIIB Non-small Cell Lung Cancer
Adjuvant osimertinib
Adjuvant chemotherapy
Additional relevant MeSH terms:
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Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
 Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Osimertinib
Tyrosine Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents