Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Osimertinib

Mitogens

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Subjects successfully enrolled into the study will receive 80mg osimertinib QD p.o. until completion of planned treatment duration, recurrence of disease, or other treatment discontinuation criteria is met. The maximum treatment duration period is 3 years.

AstraZeneca Clinical Study Information Center

This is an open-label, multi-centre, single-arm study assessing the efficacy and safety of osimertinib as adjuvant treatment in stage IB-IIIB (8th AJCC) NSCLC with uncommon EGFRm after receiving complete surgical resection with or without adjuvant chemotherapy.

Study to Assess the Efficacy and Safety of Adjuvant Osimertinib in NSCLC With Uncommon EGFRm

An Open-label, Prospective, Multi-center, Single-arm Study to Assess the Efficacy and Safety of Adjuvant Osimertinib in Non-small Cell Lung Cancer (NSCLC) With Uncommon Epidermal Growth Factor Receptor Mutations (EGFRm)

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

DFS is defined as the time from the first dosing of study treatment until the date of disease recurrence by investigator assessment or death by any cause in the absence of disease recurrence. DFS rate at 3 years is defined as the proportion of patients alive and disease free at 3 years from the first dosing of study treatment as estimated by Kaplan-Meier method, respectively. Patients who are disease-free and alive at the time of analysis will be censored at the date of their latest follow-up assessment known to be disease-free

DFS is defined as the time from the first dosing of study treatment until the date of disease recurrence by investigator assessment or death by any cause in the absence of disease recurrence. DFS rate at 2 years is defined as the proportion of patients alive and disease free at 2 years from the first dosing of study treatment as estimated by Kaplan-Meier method, respectively. Patients who are disease-free and alive at the time of analysis will be censored at the date of their latest follow-up assessment known to be disease-free.

DFS is defined as the time from the first dosing of study treatment until the date of disease recurrence by investigator assessment or death by any cause in the absence of disease recurrence. DFS rate at 5 years is defined as the proportion of patients alive and disease free at 5 years from the first dosing of study treatment as estimated by Kaplan-Meier method, respectively. Patients who are disease-free and alive at the time of analysis will be censored at the date of their latest follow-up assessment known to be disease-free.

OS (Overall survival) is defined as the time from the first dosing of study treatment to the date of death from any cause; OS rate at 2 years is defined as the proportion of patients alive at 2 years from the first dosing of study treatment; Following disease recurrence, patients will be followed up for survival every 24 weeks until study completion

OS (Overall survival) is defined as the time from the first dosing of study treatment to the date of death from any cause; OS rate at 3 years is defined as the proportion of patients alive at 3 years from the first dosing of study treatment; Following disease recurrence, patients will be followed up for survival every 24 weeks until study completion

OS (Overall survival) is defined as the time from the first dosing of study treatment to the date of death from any cause; OS rate at 4 years is defined as the proportion of patients alive at 4 years from the first dosing of study treatment; Following disease recurrence, patients will be followed up for survival every 24 weeks until study completion

OS (Overall survival) is defined as the time from the first dosing of study treatment to the date of death from any cause; OS rate at 5 years is defined as the proportion of patients alive at 5 years from the first dosing of study treatment; Following disease recurrence, patients will be followed up for survival every 24 weeks until study completion

DFS is defined as the date from first dosing of study treatment until the date of disease recurrence by investigator assessment or death from any cause in the absence of disease recurrence.Patients will be evaluated for disease recurrence at 12 weeks, 24 weeks, relative to enrollment, and then every 24 weeks until recurrence or 5 years. It is important to follow the assessment schedule as closely as possible.

DFS is defined as the time from the first dosing of study treatment until the date of disease recurrence by investigator assessment or death by any cause in the absence of disease recurrence. DFS rate at 4 years is defined as the proportion of patients alive and disease free at 4 years from the first dosing of study treatment as estimated by Kaplan-Meier method, respectively. Patients who are disease-free and alive at the time of analysis will be censored at the date of their latest follow-up assessment known to be disease-free.

Spots Global Cancer Trial Database for Study to Assess the Efficacy and Safety of Adjuvant Osimertinib in NSCLC With Uncommon EGFRm

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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