Study for Treatment With TH-4000 (Tarloxotinib) in Epidermal Growth Factor Receptor (EGFR) Mutant, T790M-negative Non-small Cell Lung Cancer (NSCLC) Patients

Key Eligibility Criteria:

Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Confirmed recurrent Stage IV NSCLC which progressed while on treatment with EGFR TKI
Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Documented evidence of an EGFR mutation known to be associated with an EGFR TKI sensitivity
No T790M mutation or small cell transformation including an assessment from tumor biopsy obtained while on or subsequent to the most recent EGFR TKI therapy
Acceptable laboratory results as indicated by protocol
Acceptable cardiac function as indicated by protocol

Key Exclusion Criteria:

Receiving medication that prolongs QT interval, with a risk of causing Torsades de Pointes (TdP) unless ECG meets inclusion criteria while on a stable dose of the medication
Family history of long corrected QT interval (QTc) syndrome
Symptomatic central nervous system (CNS) lesions
Radiation therapy within 2 weeks prior to the first dose of study medication
Major surgery within 4 weeks or minor surgery within 2 weeks prior to the first dose of study medication
Concurrent active malignancy requiring systemic treatment
Any other serious uncontrolled medical disorders or psychological conditions that may interfere with study conduct including but not limited to: clinically significant active infection (e.g., tuberculosis, viral hepatitis, human immunodeficiency virus [HIV]), recent (within 6 months) myocardial infarction or unstable angina, congestive heart failure, poorly-controlled hypertension or diabetes, concurrent active malignancy, or psychiatric condition that may interfere with the patient's ability to follow study procedures
Pregnant or breast-feeding