Study of SPI-1620 in Combination With Docetaxel Versus Docetaxel Alone for Patients With Non Small-cell Lung Cancer (NSCLC)

This will be a two part study. In Single Arm Part, patients will receive 11 μg/m2 of
SPI-1620 IV followed by docetaxel 75 mg/m2 IV. Cycles will continue every 3 weeks until
progression or intolerable toxicity. Overall 27 patients will be enrolled in the Single Arm
Part. If 6 or more responses (CR/PR) are observed in this group then the Randomized Part
will be initiated.

In the Randomized Part approximately 200 patients (100 per arm) will be randomized to
receive SPI-1620 plus docetaxel or docetaxel alone.

In the experimental arm, patients will receive 11 μg/m2 of SPI-1620 IV followed by docetaxel
75 mg/m2 IV administered in 3-week cycles until progression or intolerable toxicity. In the
control arm, patients will receive 75 mg/m2 docetaxel in 3-week cycles until progression or
intolerable toxicity.

Inclusion Criteria:

- Histologically or cytologically confirmed locally advanced or metastatic NSCLC that
has failed one prior platinum-containing chemotherapy

- Measurable disease as per RECIST v. 1.1

- ECOG performance status of 0, 1 or 2

- Adequate bone marrow, liver and renal function

Exclusion Criteria:

- More than one prior chemotherapy regimen for metastatic NSCLC

- Known, uncontrolled CNS metastases

- Significant circulatory disorders in the past 6 mo.

- Concomitant treatment with phosphodiesterase inhibitors

- Uncontrolled orthostatic hypotension, asthma or COPD