Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Written informed consent obtained prior to any screening procedures.
Histologically documented locally advanced or metastatic, stage IIIB/ IIIC or stage IV NSCLC with documented EGFR activating mutation (L858R or ex19del)
Provision of a tumor tissue sample to allow for retrospective analysis of EGFR mutation status
No prior treatment with any systemic antineoplastic therapy in the advanced setting
Recovered from all toxicities related to prior treatment
Presence of at least one measurable lesion according to RECIST 1.1
Eastern Cooperative Oncology Group (ECOG) performance ≤1
Meet the following laboratory values at the screening visit:
* Absolute Neutrophil Count ≥1.5 x 109/L
* Platelets ≥75 x 109/L
* Hemoglobin (Hgb) ≥9 g/dL
* Creatinine Clearance ≥ 45 mL/min using Cockcroft-Gault formula
* Total bilirubin ≤1.5 x ULN
* Aspartate transaminase (AST) ≤ 3.0 x ULN, except for patients with liver metastasis, who may only be included if AST ≤5.0 x ULN
* Alanine transaminase (ALT) ≤ 3.0 x ULN, except for patients with liver metastasis, who may only be included if ALT ≤5.0 x ULN
You may not be if
Prior treatment with EGFR-TKI.
Known T790M positive mutation. Any other known EGFR activating mutations other than L858R or ex19del. Patients whose tumors harbor other EGFR mutations concurrent with L858R or ex19del EGFR mutations are eligible.
Symptomatic brain metastases
History of interstitial lung disease or interstitial pneumonitis
Any medical condition that would, in the investigator's judgment, the patient's in the study due to safety concerns, compliance with clinical study procedures or interpretation of study results
Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years..
Presence of clinically significant ophthalmologic abnormalities
Bullous and exfoliative skin disorders of any grade
Presence or history of microangiopathic hemolytic anemia with thrombocytopenia.
Known history of testing positive for human immunodeficiency virus (HIV) infection
Cardiac or cardiac repolarization abnormality
Major surgery: ≤4 weeks to starting study treatment or who have not recovered from side effects of such procedure.
Unable or unwilling to swallow tablets or capsules
Female patients who are either pregnant or nursing
Women of child bearing potential who refuse or are not able to use a highly effective method of contraception as defined in the study protocol.
Sexually active males unless they use a condom during intercourse while taking drug and for 3 months after the last dose of study treatment.
Clareo Health | Phase III Study of Nazartinib (EGF816) Versus Erlotinib/Gefitinib in First-line Locally Advanced / Metastatic NSCLC With EGFR Activating Mutations
