This is a Phase 2 and open-label (subject will know the treatment he or she is receiving) study. The subject will receive either Erlotinib alone or Erlotinib + CS-7017 in this study. The study will determine what effect adding CS-7017 to Erlotinib has on safety and length of survival in subjects with advanced non-small cell lung cancer who failed the first treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
DHHA
Denver, Colorado, United States
Gabrail Cancer Center
Canton, Ohio, United States
Summary of Analysis of Progression-Free Survival Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy
Progression-free survival (PFS) was defined as the time from randomization date of the first objective documentation of disease progression or death resulting from any cause, whichever comes first.
Time frame: Baseline to disease progression or death, up to approximately 2.5 years
Analysis of Overall Survival Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy
Overall survival (OS) was defined as the time from randomization until death from any cause.
Time frame: Baseline to death, up to approximately 2.5 years
Overall Response Rate Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy
The overall response rate (ORR) was defined as the proportion of participants who achieved best overall response of complete response (CR) or partial response (PR); ORR = CR + PR. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, CR was defined as the disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
Time frame: Baseline to disease progression or death, up to approximately 2.5 years
Summary of Treatment-Emergent Adverse Events (TEAEs) Occurring in ≥10% of Participants Following Administration of CS-7017 and Erlotinib in Participants With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy
A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset date on or after the first dose of CS-7017 or erlotinib up to and including 30 days after the last dose of any study drug, or worsened in severity after the first dose of CS-7017 or erlotinib relative to the pre-treatment state.
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Providence Regional Medical Center Everett
Everett, Washington, United States
Zentrum fur Pneumologie und Thoraxchirurgie
Gauting, Germany
King George Hospital
Visakhapatnam, Andhra Pradesh, India
Vedanta Institute of Medical Sciences
Ahmedabad, Gujarat, India
Kodlikeri Memorial Hospital
Aurangabad, Maharashtra, India
Tata Memorial Hospital
Mumbai, Maharashtra, India
Noble Hospital
Pune, Maharashtra, India
Apollo Speciality Hospital
Chennai, Tamil Nadu, India
...and 7 more locations
Time frame: Baseline to 30 days after last dose, up to approximately 2.5 years