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Clinical Trials List

Protocol NumberD516FC00001
NCT Number(ClinicalTrials.gov Identfier)NCT05120349
Active

2021-12-01 - 2032-12-31

Phase III

Recruiting8

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

A Phase III, Double-blind, Randomised, Placebo-Controlled, International Study to Assess the Efficacy and Safety of Adjuvant Osimertinib Versus Placebo in Participants With EGFR Mutation-positive Stage IA2-IA3 Non-small Cell Lung Cancer, Following Complete Tumour Resection

  • Trial Applicant

  • Sponsor

    AstraZeneca

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator kang-Yun LEE Division of Thoracic Medicine
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator JIN-SHING CHEN Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSUNG -YING YANG Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Gee-chen Chang Division of Hematology & Oncology
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Han-Shui Hsu Division of Thoracic Surgery
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 黃才旺 Division of Thoracic Surgery
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yau-Lin Tseng Division of Thoracic Surgery
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Cheng-Ta Yang Division of Thoracic Medicine
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Non-Small Cell Lung Cancer

Objectives

This is a Phase III, double-blind, randomised, placebo-controlled, 2-arm, international study assessing the efficacy and safety of adjuvant osimertinib versus placebo in participants with stage IA2-IA3 EGFRm Non-Small Cell Lung Cancer, who have previously undergone complete tumour resection. All participants must have had a tumour which harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R).

Test Drug

TAGRISSO Film-coated Tablets 40 mg/ TAGRISSO Film-coated Tablets 80 mg

Active Ingredient

Osimertinib
Osimertinib

Dosage Form

Tablets
Tablets

Dosage

40mg
80mg

Endpoints

Disease-Free Survival (DFS) in high-risk stratum
DFS is defined as the time from the date of randomisation until the date of disease recurrence or date of death (by any cause in the absence of recurrence), whichever occurs first.

Inclution Criteria

Male or female, at least ≥ 18 years.
NSCLC, of non-squamous histology.
Stage IA2 or IA3 disease, based on TNM8 classification.
Complete surgical resection (R0) of the primary NSCLC by lobectomy, segmentectomy or sleeve resection.
Complete recovery from surgery at the time of randomisation. Study intervention cannot commence within 4 weeks following surgery. No more than 12 weeks may have elapsed between surgery and randomisation for participants.
World Health Organization performance status of 0 or 1.
Provision of tumour sample for central pathology assessment of pathologic risk factors and to assess EGFR mutation status prior to randomisation.
A tumour which harbours one of the 2 EGFR mutations (Ex19del, L858R) by cobas® EGFR Mutation Test v2 (Roche Diagnostics) or FoundationOne® test.
Minimum life expectancy of > 6 months.
Females must be using highly effective contraceptive measures, and must have a negative pregnancy test prior to start of dosing if of child-bearing potential, or must have evidence of non-child-bearing potential. Male subjects must be willing to use barrier contraception.

Exclusion Criteria

Mixed small cell and non-small cell cancer history.
Participants with incomplete (R1/R2) resection, or who have undergone pneumonectomy, bilobectomy or only wedge resection.
Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C and HIV.
History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 5 years before the first dose of study intervention and of low potential risk for recurrence.
Any of the following cardiac criteria:

Mean resting QTc interval > 470 ms, obtained from triplicate ECGs performed at screening.
Any abnormalities in rhythm, conduction, or morphology of resting ECG,
Any factors that increase the risk of QTc prolongation or risk of arrhythmic events.
History of interstitial lung disease.
Inadequate bone marrow reserve or organ function.
Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study intervention.
Prior treatment with any anticancer therapy for NSCLC (including chemotherapy, radiotherapy, immunotherapy, and EGFR-TKIs).
Major surgery or significant traumatic injury within 4 weeks of the first dose of study intervention.
Participants currently receiving medications or herbal supplements known to be strong inducers of CYP3A4.

The Estimated Number of Participants

  • Taiwan

    70 participants

  • Global

    380 participants

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