C349 Bronchus or lung, unspecified Bronchus or lung, unspecified
Conditions
Interventions
None listed
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Part I Screening Part I screening applies only to patients that do not have a pre-existing local positive (Exon 19 deletion or L858R) cobas® EGFR Mutation Test v2 (Roche Diagnostics) in a CLIA-certified (USA sites) or an accredited local laboratory (sites outside of the USA) conducted according to the cobas® EGFR Mutation Test v2 instructions for use. Patients are eligible to be included in the study only if all of the following inclusion criteria apply and none of the Part II screening exclusion criteria numbers 1, 2, 7, 9-11 and 15-20 apply: Informed consent 1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol 2. Provision of signed and dated written informed consent for Part I screening form prior to any mandatory provision of tumor samples for testing of EGFR mutation status. Age and Sex 3. Male and Female patient must be aged at least 18 years. Patients from Japan aged at least 20 years. Type of patient and disease characteristics 4. Patients with histologically documented NSCLC of predominantly non-squamous pathology who present with locally advanced, unresectable (Stage III) disease (according to Version 8 of the International Association for the Study of Lung Cancer [IASLC] Staging Manual in Thoracic Oncology). It is recommended but not required that except for overt cT4 disease, nodal status N2 or N3 should have been proven by biopsy, via endobronchial ultrasound, mediastinoscopy, or thoracoscopy or in absence of biopsy, should have been confirmed with whole body 18F-fluoro-deoxyglucose positron emission tomography (PET) plus contrast-enhanced computed tomography (CT) in addition to or in combination with PET 5. Patient who can provide an unstained archived formalin-fixed paraffin embedded tumor tissue sample in a quantity sufficient to allow for prospective central analysis of EGFR mutation status. Further information is provided page 50 to 54 of the protocol
Exclusion criteria
Exclusion criteria: Part II Screening Patients are eligible to be included in Part II screening process only if none of the exclusion criteria apply: Medical conditions 1. Mixed small cell and non-small cell lung cancer histology 2. History of interstitial lung disease (ILD) prior to chemoradiation. 3. Symptomatic pneumonitis following chemoradiation. 4. Any unresolved toxicity Common Terminology Criteria for Adverse Events (CTCAE) > Grade 2 from the prior chemoradiation therapy. Patients with irreversible toxicity that is not reasonably expected to be exacerbated by study drug may be included (e.g. hearing loss) after consultation with the AstraZeneca medical monitor. 5. Any of the following cardiac criteria: ? Mean resting corrected QT interval (QTc) >470 msec, obtained from 3 ECGs ? Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG, e.g., complete left bundle branch block, third-degree heart block, seconddegree heart block. ? Patient with any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long 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-See section 6.5.2 for more details. Further information is provided page 54 to 56 of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) using Blinded Independent Central Review (BICR) assessment according to RECIST v1.1 NAME OF THE RESULT: Progression free survival (PFS) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Every 8 weeks (± 1 week) for the first 48 weeks and then change to every 12 weeks (relative to randomization) until BICR-confirmed PD | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) using Blinded Independent Central Review (BICR) assessment according to RECIST v1.1 NAME OF THE RESULT: Progression free survival (PFS) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Every 8 weeks (± 1 week) for the first 48 weeks and then change to every 12 weeks (relative to randomization) until BICR-confirmed PD;Time to CNS PFS (time to the earliest of CNS progression or death) using BICR assessments according to RECIST v1.1 NAME OF THE RESULT: Time to CNS PFS (time to the earliest of CNS progression or death) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Every 8 weeks (± 1 week) for the first 48 weeks and then change to every 12 weeks (relative to randomization) until BICR-confirmed PD | — |
Countries
Argentina, China, India, Japan, Korea South, Peru, Spain, Taiwan, Thailand, Turkey, United States, Vietnam
Outcome results
None listed