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

A 2-Part Phase 2 Study of SPI-1620 in Combination With Docetaxel Versus Docetaxel Alone for Patients With Non Small-cell Lung Cancer After Failure of First-line Platinum-based Chemotherapy

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01741155

Enrollment

Registered

2012-12-04

Start date

2013-05-31

Completion date

2015-07-31

Last updated

2021-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer (NSCLC)

Brief summary

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.

Detailed description

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.

Interventions

DRUGSPI-1620

SPI-1620 11 μg/m2 administered intravenously over one minute.

DRUGDocetaxel

Docetaxel: 75 mg/m2 administered as IV infusion.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Objective Response Rate(ORR) of SPI-1620	Up to 2 years	To estimate and compare the objective response rate of SPI-1620 administered in combination with docetaxel in patients with NSCLC

Secondary

Measure	Time frame	Description
Duration of Response (DoR)	Up to 12 weeks	only in Randomized Part.
Progression-free survival(PFS)	2 years from the start of study treatment	only in Randomized Part
Overall survival (OS)	2 years from the start of study treatment	—
Safety of SPI-1620	Up to 2 years	Periodic physical examinations with vital sign monitoring, safety laboratories and monitoring of adverse events will be performed.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026