Clinical trial · Interventional
A Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced NSCLC
A Randomized, Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced Non-Small-Cell Lung Adenocarcinoma
NCT01798485CI-TRIAL-00022802Galaxy 2terminatedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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 was stopped after the first Interim Analysis due to futility.
Summary
Brief summary (as posted)
The purpose of this study is to determine whether combining ganetespib (STA-9090) with docetaxel is more effective than docetaxel alone in the treatment of patients with advanced non-small cell lung cancer.
Conditions
Conditions (4)
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 Adenocarcinoma | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer Metastatic | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer Stage IIIB | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Non-small Cell Lung Cancer Stage IV | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Ganetespib | Drug | Ganetespib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ganetespib and Docetaxel
- description
- Ganetespib (150 mg/m\^2) and docetaxel (75 mg/m\^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
- interventionNames
- Drug: Docetaxel
- Drug: Ganetespib
- type
- ACTIVE_COMPARATOR
- label
- Docetaxel
- description
- Docetaxel (75 mg/m\^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
- interventionNames
- Drug: Docetaxel
Primary outcomes (1)
- measure
- Overall Survival as of 19 October 2015
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced Stage IIIB or IV non-small-cell lung cancer (NSCLC) * Eastern Oncology Cooperative Group (ECOG) Performance Status 0 or 1 * Prior therapy defined as 1 prior systemic therapy for advanced disease * Documented disease progression during or following most first line therapy for advanced disease * Adequate hematologic, hepatic, renal function Exclusion Criteria: * Epidermal growth factor receptor (EGFR) mutations * Anaplastic lymphoma kinase (ALK) translocations * Predominantly squamous, adenosquamous or unclear histologic type * Active or untreated central nervous system (CNS) metastases * Active malignancies other than NSCLC within the last 5 years with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin * Serious cardiac illness or medical conditions * Pregnant or lactating women * Uncontrolled intercurrent illness
References
Publications (0)
Data not yet available
No reference posted for this study.