The study will be conducted in two parts:
The purpose of part 1 is to assess the safety and tolerability of irinotecan liposome injection monotherapy and to determine the irinotecan liposome injection monotherapy dose for part 2 of the study.
The purpose of part 2 is to assess irinotecan liposome injection versus intravenous topotecan in patients with small cell lung cancer who have progressed on or after platinum-based first-line therapy.
Accepting new patients
The primary objectives of part 1 are to describe the safety and tolerability of irinotecan liposome injection monotherapy administered every two weeks and to determine the irinotecan liposome injection monotherapy dose for part 2 of this study.
The primary objective of part 2 is to test whether overall survival, defined as the time from study randomization to date of death, is increased in patients treated with irinotecan liposome injection.
Note: This is only a partial list of eligibility criteria.
Including patients who:
Excluding patients who:
Accepting new patients
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Principal Investigator(s)