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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 179
- Locations
- 58
- Primary Endpoint
- Progression Free Survival (PFS)
Study Overview
Brief Summary
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)
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Cabazitaxel
Intervention: Cabazitaxel (Drug)
Topotecan
Intervention: Topotecan (Drug)
Outcomes
Primary Outcomes
Progression Free Survival (PFS)
Time Frame: Randomization to first tumor progression/clinical deterioration or death (maximum 7.6 months)
PFS was defined as the time interval from the date of randomization to the date of occurrence of the first documented tumor progression or death due to any cause, whichever came first. Median PFS was estimated using the Kaplan-Meier method. Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study or unequivocal progression of existing non-target lesion. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions is also considered progression.
Secondary Outcomes
- Overall Survival(From randomization to date of death (maximum 15 months))
- Progression Free Rate at Week 12(Week 12)
- Overall Objective Tumor Response Rate(Randomization to disease progression/occurrence (maximum 7.6 months))