A Multi-center, Open-Label, Adaptive, Randomized Study of Palifosfamide-tris, a Novel DNA Crosslinker, in Combination With Carboplatin and Etoposide (PaCE) Chemotherapy Versus Carboplatin and Etoposide (CE) Alone in Chemotherapy Naïve Patients With Extensive-Stage Small Cell Lung Cancer. The MATISSE Study

Inclusion Criteria:

- Documented extensive-stage small cell lung cancer.

- Patient has received no prior chemotherapy, adjuvant therapy, or radiotherapy for
lung cancer.

- ECOG Performance Status of 0, 1 or 2.

- Adequate bone marrow and organ function based on the results of protocol- specified
laboratory tests.

- Male and female patients must agree to use a highly reliable method of birth control
during study participation.

- Able to provide informed consent

Exclusion Criteria:

- Previously untreated (non-irradiated), symptomatic brain metastases.

- Known allergy to any of the study drugs or their excipients.

- Any unstable or clinically significant concurrent medical condition that would, in
the opinion of the investigator, jeopardize the safety of a patient and/or their
compliance with the protocol, based on screening tests, physical examination and
medical history (as specifically defined in the clinical protocol).

- Any malignancy other than small cell lung cancer within the last 5 years prior to
randomization, with the exception of cervical carcinoma in situ, nonmelanoma skin
cancer, or superficial bladder tumors (Ta, Tis, or T1) that have been successfully
and curatively treated with no evidence of recurrent or residual disease. (Exception:
Subjects with a history of malignancy other than small cell lung cancer may be
enrolled after consultation with the medical monitor provided the patient's prognosis
is best defined by the extensive-stage small cell lung cancer).

- Currently pregnant or nursing.