Clinical trial · Interventional
Docetaxel +/- Suramin in 2nd Line Advanced Non-Small Cell Lung Cancer
Randomized Phase II Study of Suramin and Docetaxel Versus Docetaxel in Non-Small Cell Lung Cancer After Failure of First-Line Chemotherapy
NCT01671332CI-TRIAL-00045040completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The overall purpose of the study is to determine whether or not the inclusion of suramin to standard treatment with docetaxel improves progression-free survival for patients with advanced non-small cell lung cancer in the second and third line settings.
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 |
|---|---|---|---|
| Carcinoma, Non Small Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Suramin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Docetaxel
- interventionNames
- Drug: Docetaxel
- type
- EXPERIMENTAL
- label
- Docetaxel plus Suramin
- interventionNames
- Drug: Suramin
- Drug: Docetaxel
Primary outcomes (1)
- measure
- Progression-free Survival in Months
- timeFrame
- Up to 1 year
- description
- Compare progression-free survival (PFS) in participants with advanced NSCLC treated with docetaxel with or without suramin after failure of first-line chemotherapy. PFS is defined as the duration of time from the time of randomization to time of disease progression or death, whichever occurs first.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically proven diagnosis of non-small cell lung cancer * Documented disease progression after first-line chemotherapy for non-small cell lung cancer * Stable and treated CNS metastasis is allowed * Radiation must be completed at least 2 weeks prior to starting protocol treatment * Major surgery must be completed at least 4 weeks prior to starting protocol treatment * ECOG performance status 0-2 * Sexually active patients must use adequate contraception * Adequate bone marrow function * Adequate renal function * Adequate liver function Exclusion Criteria: * Severe hypersensitivity reaction to docetaxel * Pre-existing grade 3 or 4 neuropathy * Women who are pregnant or breastfeeding * Uncontrolled intercurrent illness * Receipt of 3 or more prior chemotherapy regimens
References
Publications (0)
Data not yet available
No reference posted for this study.