Clinical trial · Interventional
A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Advanced Nonsmall-Cell Lung Cancer
A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Patients With Advanced Non-small Cell Lung Cancer
- 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 purpose of this study is to determine whether progression-free survival with ixabepilone is superior to that achieved with paclitaxel plus carboplatin in participants with advanced nonsmall-cell lung cancer and beta III (βIII)-tubulin-positive tumors.
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 |
|---|---|---|---|
| Advanced/Metastatic Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin (area under the concentration curve [AUC] 6) | Drug | Carboplatin | ALIAS |
| Ixabepilone, 32 mg/m^2 | Drug | — | UNRESOLVED |
| Paclitaxel, 200 mg/m^2 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ixabepilone, 32 mg/m^2 + Carboplatin (AUC 6)
- interventionNames
- Drug: Ixabepilone, 32 mg/m^2
- Drug: Carboplatin (area under the concentration curve [AUC] 6)
- type
- ACTIVE_COMPARATOR
- label
- Paclitaxel, 200 mg/m^2 + Carboplatin (AUC 6)
- interventionNames
- Drug: Paclitaxel, 200 mg/m^2
- Drug: Carboplatin (area under the concentration curve [AUC] 6)
Primary outcomes (1)
- measure
- Progression-free Survival in the Subgroup of Participants With βIII-tubulin Positive Tumors
- timeFrame
- Randomization to disease progression or death (maximum reached: 14.39 months )
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed non-small cell lung cancer (NSCLC)(squamous cell, adenocarcinoma, large cell, or bronchoalveolar carcinoma) * Stage IIIB NSCLC with pleural effusion, Stage IV NSCLC, or recurrent disease following surgery with or without radiation therapy * Available paraffin-embedded tissue to measure the expression levels of βIII tubulin * Disease measurable by Response Evaluation Criteria in Solid Tumors, with at least 1 target lesion situated outside any previous radiotherapy field * Karnofsky performance status of 70-100 * Life expectancy of at least 3 months * Men and women, ages 18 years and older Exclusion Criteria: * Uncontrolled brain metastases * Peripheral neuropathy greater than Grade 1 * Fewer than 4 weeks from prior radiation therapy or locoregional surgeries to randomization date (less than 1 week from focal/palliative radiotherapy or minor surgery) * Any concurrent malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix * Known HIV-positive status * Absolute neutrophil count lower than 1500 cells mm\^3 * Total bilirubin level higher than upper limit of normal (ULN) as defined by the institution (with the exception of elevation due to Gilbert's syndrome) * Aspartate transaminase or alanine transaminase level higher than 2.5\*ULN * Serum creatine level of 1.5 mg/dL or higher * Renal function with a creatinine clearance of less than 50 mL/min (as calculated with the Cockcroft and Gault equation) * Any prior antineoplastic systemic regimens.
References
Publications (1)
- DERIVEDEdelman MJ, Schneider CP, Tsai CM, Kim HT, Quoix E, Luft AV, Kaleta R, Mukhopadhyay P, Trifan OC, Whitaker L, Reck M. Randomized phase II study of ixabepilone or paclitaxel plus carboplatin in patients with non-small-cell lung cancer prospectively stratified by beta-3 tubulin status. J Clin Oncol. 2013 Jun 1;31(16):1990-6. doi: 10.1200/JCO.2012.45.3282. Epub 2013 Apr 15. PMID 23589560