Small Cell Lung Cancer Clinical Trial
Official title:
Randomized Phase II Study of Cabazitaxel Versus Topotecan in Small Cell Lung Cancer Patients With Progressive Disease During or After a First Line Platinum Based Chemotherapy
Primary Objective:
To demonstrate progression free survival (PFS) improvement for cabazitaxel compared to
topotecan in participants with sensitive or resistant/refractory small cell lung cancer
following a first line platinum based chemotherapy.
Secondary Objectives:
- To assess disease progression free rate at 12 weeks
- To assess Response Rate (Response Evaluation Criteria in Solid Tumor [RECIST] 1.1) and
duration of response
- To assess Overall Survival (OS)
- To assess the Safety (National Cancer Institute - Common Toxicity Criteria [NCI-CTC]
version 4.03)
- To assess the Health-Related Quality of Life (HRQoL)
Participants are to be treated until progressive disease, unacceptable toxicity or refusal
for further study treatment.
All participants are to be followed for disease progression documentation and for
participant status until the study cut-off date.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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