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Clinical Trials List

Protocol NumberD516AC00001
NCT Number(ClinicalTrials.gov Identfier)NCT04351555
Active

2020-08-21 - 2029-05-31

Phase III

Recruiting7

ICD-10C33

Malignant neoplasm of trachea

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.0

Malignant neoplasm of trachea

A Phase III, Randomised, Controlled, Multi-center, 3-Arm Study of Neoadjuvant Osimertinib as Monotherapy or in Combination With Chemotherapy Versus Standard of Care Chemotherapy Alone for the Treatment of Patients With Epidermal Growth Factor Receptor Mutation Positive, Resectable Non-small Cell Lung Cancer

  • 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 Yuh-Min Chen Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳昭勳 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Gee-chen Chang Division of Thoracic Medicine
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator JIN-YUAN SHIH Division of Thoracic Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Han-Pin Kuo Division of Thoracic Medicine
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Te-Chun Hsia Division of Thoracic Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Epidermal Growth Factor Receptor Mutation Positive, Resectable Non-small Cell Lung Cancer

Objectives

Primary objective: To determine the efficacy of osimertinib as monotherapy or in combination with chemotherapy compared to chemotherapy alone, as neoadjuvant treatment Secondary objectives: To further assess the efficacy of osimertinib as monotherapy or in combination with chemotherapy compared to chemotherapy alone as neoadjuvant treatment, by assessment of pathological complete response (pCR), EFS, DFS, downstaging and Overall survival (OS). To assess impact of treatment on patients’ disease-related symptoms and health-related quality of life in patients To further assess the efficacy of osimertinib as monotherapy or in combination with chemotherapy as compared to chemotherapy alone as neoadjuvant treatment, in patients with or without EGFRm detectable at screening in plasma-derived circulating-free tumour DNA (ctDNA) To compare the baseline tumour EGFR mutation status in screened patients with evaluable results from baseline plasma samples. To compare the local cobas® EGFR Mutation Test v2 and FoundationOne® CDx results used for patient selection with the retrospectivecentral cobas® EGFR Mutation Test v2 results from baseline tumour samples. To characterise the pharmacokinetics (PK) of osimertinib and its metabolites

Test Drug

Osimertinib (AZD9291/TAGRISSOR/泰格莎)

Active Ingredient

Osimertinib

Dosage Form

Film-coated tablet
Film-coated tablet

Dosage

40
80

Endpoints

Primary Outcome Measures :
Major Pathological Response (MPR) [ Time Frame: From date of randomization to an average of 12 weeks after the first dose ]
Defined as ≤10% residual cancer cells in the main tumour, as assessed per central pathology laboratory post-surgery


Secondary Outcome Measures :
Pathological complete response (pCR) [ Time Frame: From date of randomization to an average of 12 weeks after the first dose ]
Defined as absence of any residual cancer cells in the dissected tumour samples, including the main tumour and lymph nodes, assessed post-surgery

Event-free survival (EFS) [ Time Frame: Up to approximately 42 months after the last patient is randomized ]
An event is defined as documented disease progression that precludes surgery or requires non-protocol therapy; recurrence or a new lesion, local or distant (a new primary malignancy confirmed by pathology is not considered to be an EFS event.); death due to any cause

Overall Survival (OS) [ Time Frame: Up to approximately 5.5 years after the last patient is randomized ]
Patients will be followed up to approximately 5.5 years after they are randomized.

Disease free survival (DFS) [ Time Frame: From date of randomization up to approximately 42 months after date of resection ]
DFS is defined as the time from the date of surgery until the first date of disease recurrence (local or distant) or date of death due to any cause, whichever occurs first.

Downstaging [ Time Frame: From date of randomization to an average of 12 weeks after the first dose ]
Measured using pathologic mediastinal lymph node evaluation

Difference between treatment arms in change from baseline in EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 items) [ Time Frame: From randomization to 264 weeks post-surgery ]
Assess disease-related symptoms, functioning, and global health status/quality-of-life in patients

Concordance of EGFRm status between tumour tissue DNA and patient-matched plasma-derived ctDNA [ Time Frame: Baseline ]
Corcordance of EGFR mutation status between the local and central cobas EGFR mutation test results from baseline tumour samples [ Time Frame: Baseline ]
PK plasma concentrations of osimertinib [ Time Frame: From the pre-dose of Cycle 2 to post-dose of Cycle 3 (each cycle is 21 days) ]
Difference between treatment arms in change from baseline in EORTC QLQ-LC13 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 items) [ Time Frame: From randomization to 264 weeks post-surgery ]
Assess lung cancer-associated symptoms and side effects from conventional chemotherapy and radiotherapy


Other Outcome Measures:
Cure rate [ Time Frame: From the surgery until 5 years after surgery ]
The cure rate is defined as the percentage of people in this study who are still alive and disease free for a certain period of time after they finished the surgery. Here 5-year landmark cure rate will be calculated in the same time as OS analysis.

Number of adverse events as assessed by CTCAE 5.0 and other clinical variables for safety and tolerability profile of neoadjuvant osimertinib as monotherapy or in combination with chemotherapy prior to surgery compared with chemotherapy alone [ Time Frame: From the time of enrollment to either 28-days after the last dose of last study treatment for patients who do not undergo surgery, or 90-days post-surgery ]
Other clinical variables include deaths, laboratory data, vital signs (pulse and BP), ECG, LVEF, ECOG performance status, and ophthalmologic assessment

MPR using plasma-derived circulating-free tumour DNA (ctDNA) [ Time Frame: From randomization to 5 years post-surgery ]

Inclution Criteria

Inclusion Criteria:

Male or female, at least 18 years of age. For patients aged <20 years and enrolled in Japan, a written informed consent should be obtained from the patient and his or her legally acceptable representative
Histologically or cytologically documented non-squamous NSCLC with completely resectable (Stage II - IIIB N2) disease (according to Version 8 of the IASLC Cancer Staging Manual [IASLC Staging Manual in Thoracic Oncology 2016]).
Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by a MDT evaluation (which should include a thoracic surgeon, specialised in oncologic procedures).
Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1 at enrolment, with no deterioration over the previous 2 weeks prior to baseline or day of first dosing
A tumour which harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations (ie, T790M, G719X, Exon20 insertions, S7681 and L861Q).

Exclusion Criteria

Exclusion Criteria:

Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
History of another primary malignancy, except for the following: Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of investigational product (IP) and of low potential risk for recurrence; Adequately treated non-melanoma skin cancer or lentigo malignancy without evidence of disease; Adequately treated carcinoma in situ without evidence of disease
Patients who have pre-operative radiotherapy treatment as part of their care plan
Mixed small cell and NSCLC histology
Stages I, IIIB N3, IIIC, IVA, and IVB NSCLC
T4 tumours infiltrating the aorta, the oesophagus and/or the heart; and/or any bulky N2 disease
Patients who are candidates to undergo only segmentectomies or wedge resections
Prior treatment with any systemic anti-cancer therapy for NSCLC including chemotherapy, biologic therapy, immunotherapy, or any investigational drug
Prior treatment with EGFR-TKI therapy
Current use of (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of cytochrome P450 (CYP) 3A4 (at least 3 weeks prior)

The Estimated Number of Participants

  • Taiwan

    35 participants

  • Global

    351 participants

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