The study did not meet efficacy end point and did not enroll patients in the randomized phase.

The purpose of this study is to estimate and compare the objective response rate of SPI-1620 administered in combination with docetaxel in patients with NSCLC and to determine the safety of SPI-1620 when administered in combination with docetaxel.

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
• Eastern Cooperative Oncology Group (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 central nervous system (CNS) metastases
• Significant circulatory disorders in the past 6 mo.
• Concomitant treatment with phosphodiesterase inhibitors
• Uncontrolled orthostatic hypotension, asthma or chronic obstructive pulmonary disease (COPD)