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

Inclusion Criteria

Inclusion criteria :

- Histological/cytological proven locally advanced or metastatic small cell lung cancer
with progressive disease during or after first line platinum based chemotherapy

- Male or female ≥18 years (or country's legal age of majority if >18 years)

- Patients with measurable disease, RECIST (version 1.1)

- ECOG performance status ≤1

Exclusion criteria:

- Absence of signed and dated Institutional Review Board (IRB)-approved patient
informed consent form prior to enrollment into the study.

- More than one prior chemotherapy regimen. Prior treatment with topotecan or taxanes.

- Less than 28 days elapsed from prior treatment with chemotherapy, radiotherapy or
surgery to the time of randomization. (Radiotherapy for bone pain palliation is
allowed).

- Adverse events (excluding alopecia) from any prior anticancer therapy of grade
>1(National Cancer Institute Common Terminology Criteria [NCI CTCAE] v4.03) at the
time of randomization.

- Uncontrolled CNS metastases: patients with CNS metastases may have previous
irradiation, only patients with SD or response to irradiation who are without CNS
symptoms and on a maximum steroid dose of dexamethasone 8 mg daily or equivalent can
be included.

- Patients with known leptomeningeal metastases

- History of other, invasive neoplasm requiring ongoing therapy.

- Participation in another clinical trial and any concurrent treatment with any
investigational drug within 30 days prior to randomization

- Any of the following within 6 months prior to study enrollment: myocardial
infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft,
NYHA class III or IV congestive heart failure, stroke or transient ischemic attack.

- Any severe acute or chronic medical condition, which could impair the ability of the
patient to participate in the study or interfere with interpretation of study results

- Known HIV disease, or active hepatitis B or C (systematic testing is not required).

- Pregnant or breast-feeding woman. Positive serum or urine pregnancy test prior to
randomization

- Patient with reproductive potential (M/F) who do not agree to use an accepted and
effective method of contraception during the study treatment period and for at least
6 months after the completion of the study treatment. The definition of "effective
method of contraception" will be based on the investigator's judgment. Effective
method of contraception should also be adapted to local regulation.

- History of hypersensitivity to polysorbate 80

- Inadequate organ and bone marrow function as evidenced by:

- Hemoglobin <9.0 g/dL

- Absolute neutrophil count <1.5 x 109/L

- Platelet count <100 x 109/L

- AST/SGOT and/or ALT/SGPT >2.5 x ULN

- AP >2.5 x ULN. In case of liver metastases AP > 5 x ULN

- Total bilirubin >1.0 x ULN

- Serum Creatinine >1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance
will be calculated according to CKD-EPI formula, and creatinine clearance <60
mL/min will exclude the patient.

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.