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This is an expanded access protocol designed to make Lucanix® available to subjects with advanced non-small cell lung cancer (NSCLC) who are not eligible for the Phase III Protocol, NR001-03. A total of 45 patients will be enrolled into the study.
Full description
The primary objective of this study is to increase the overall survival of the study subjects by providing expanded access to Lucanix. Overall survival and progression-free survivals will be compared with historical controls.
The secondary objectives of this study are:
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Inclusion criteria
Signed informed consent
≥ 18 years
Histological confirmed non-curable stage III or IV NSCLC.
Must have completed at least one (1) regimen of anti-cancer therapy.
Following frontline therapy, subjects must observe the following wash- out periods:
All subjects who have received two (2) or more regimens of therapy must have received the last anti-cancer therapy at least one (1) month prior to enrollment.
Performance status (ECOG) ≤ 2
Absolute granulocyte count ≥ 1,500/mm3
Platelet count ≥ 100,000/mm3
Total Bilirubin ≤ 2× Upper Limit of Normal
AST and ALT ≤ 2× Upper Limit of Normal
Creatinine ≤ 2× Upper Limit of Normal
Negative pregnancy test for women of childbearing potential.
Exclusion criteria
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Data sourced from clinicaltrials.gov
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