Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study did not meet efficacy end point and did not enroll patients in the randomized phase.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| SPI-1620 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Single Arm Part: SPI-1620 & Docetaxel
- description
- 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.
- interventionNames
- Drug: SPI-1620
- Drug: Docetaxel
- type
- EXPERIMENTAL
- label
- Randomized Part: SPI-1620 & Docetaxel
- description
- Patients will receive 11 μg/m\^2 of SPI-1620 intravenous (IV) followed by docetaxel 75 mg/m\^2 IV administered in 3-week cycles until progression or intolerable toxicity.
- interventionNames
- Drug: SPI-1620
- Drug: Docetaxel
- type
- ACTIVE_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available