Patients with histologically or cytologically documented non-squamous NSCLC with completely resectable (Stage II - IIIB N2) disease MedDRA version: 21.1 Level: PT Classification code 10029518 Term: Non-small cell lung cancer stage II System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10029520 Term: Non-small cell lung cancer stage IIIA System Organ Class: 10029104 - Neoplasms benign, malignant an
Conditions
Interventions
Trade Name: TAGRISSO
Product Name: Osimertinib 80 mg
Product Code: AZD9291
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Osimertinib
CAS Number: 1421373-66-1
Current Sponsor code: AZD9
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female, at least 18 years of age. For patients aged =65 years) yes F.1.3.1 Number of subjects for this age range 175
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 (including any known or suspected synchronous primary lung cancer), 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; Any synchronous Stage IA primary lung cancer that is =2 cm and planned to be resected during surgery for the Stage II to IIIB N2 lung tumour. - 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 great vessels, the carina, the trachea, the oesophagus, the heart, and/or the vertebral body; 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of osimertinib as monotherapy or in combination with chemotherapy compared to chemotherapy alone, as neoadjuvant treatment;Secondary Objective: - To assess the efficacy of osimertinib as monotherapy or in combination with chemotherapy compared to chemotherapy alone as neoadjuvant treatment, by assessment of pCR, EFS, DFS, downstaging and OS - To assess impact of treatment on patients' disease-related symptoms and health-related quality of life - To 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 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 retrospective central cobas® EGFR Mutation Test v2 results from baseline tumour samples. - To characterise the PK of osimertinib and its metabolites;Primary end point(s): Major Pathological Response (MPR) (=10% residual cancer cells in the main tumour, as assessed per central pathology laboratory postsurgery);Timepoint(s) of evaluation of this end point: From date of randomization to an average of 12 weeks after the first | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Complete pathological Response (pCR) (absence of any residual cancer cells in the dissected tumour samples, including the main tumour and lymph nodes, assessed post-surgery); EFS; DFS; Downstaging; Overall Survival (OS) - Change from baseline in Patient reported outcomes (ePRO) - Concordance of EGFRm status between tumour tissue DNA and patient-matched plasma-derived ctDNA - Corcordance of EGFR mutation status between the local and central cobas EGFR mutation test results from baseline tumour samples. - PK plasma concentrations of osimertinib;Timepoint(s) of evaluation of this end point: Approximately 5.5 years after patients are randomized | — |
Countries
Austria, Brazil, Bulgaria, Chile, China, France, Germany, India, Israel, Italy, Japan, Korea, Republic of, Mexico, Peru, Poland, Russian Federation, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States, Viet Nam
Contacts
Public ContactInformation Center
AstraZeneca AB
Outcome results
None listed