Clinical trial · Interventional
Study of Paclitaxel/Carboplatin With or Without Bavituximab in Previously Untreated Non Small-Cell Lung Cancer
A Randomized, Open-Label, Phase 2 Trial of Paclitaxel/Carboplatin With or Without Bavituximab in Patients With Previously Untreated Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer
NCT01160601CI-TRIAL-00027065completedPhase 2ClinicalTrials.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)
This is a randomized, open-label, multicenter, phase 2 study comparing Paclitaxel/Carboplatin with or without bavituximab in patients that have previously untreated locally advanced or metastatic non-small cell lung cancer (NSCLC).
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-Squamous Non-Small Cell Lung Cancer | Lung Non-Squamous Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bavituximab | Drug | — | UNRESOLVED |
| Paclitaxel / Carboplatin | Drug | Carboplatin/Paclitaxel Regimen | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- paclitaxel/carboplatin plus bavituximab
- description
- Patients will receive paclitaxel (200 mg/m2) and carboplatin (target area under the concentration-time curve \[AUC\] 6) on Day 1 of each 21 day cycle for up to 6 cycles, in combination with 3 mg/kg bavituximab administered weekly.
- interventionNames
- Drug: Paclitaxel / Carboplatin
- Drug: bavituximab
- type
- ACTIVE_COMPARATOR
- label
- paclitaxel/carboplatin
- description
- Patients will receive paclitaxel (200 mg/m2) and carboplatin (target area under the concentration-time curve \[AUC\] 6) on Day 1 of each 21 day cycle for up to 6 cycles.
- interventionNames
- Drug: Paclitaxel / Carboplatin
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Adults over 18 years of age with a life expectancy of at least 3 months. * Histologically or cytologically confirmed stage IIIB or stage IV non-squamous NSCLC that has not been previously treated with systemic chemotherapy. * Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.1). * Adequate hematologic, renal and hepatic function. * PT / INR ≤ 1.5 × ULN, aPTT ≤ 1.5 × ULN and D-dimer ≤ 3 × ULN. Key Exclusion Criteria: * Squamous cell, small cell, or mixed histology. * Known history of bleeding diathesis or coagulopathy. * Cavitary tumors or tumors abutting large blood vessels. * Bleeding: Clinically significant bleeding, such as gross hematuria, GI bleeding and hemoptysis, within 12 months of Screening. * Venous thromboembolic events (e.g., deep vein thrombosis or pulmonary thromboembolism) within 6 months of Screening. * Ongoing therapy with oral or parenteral anticoagulants. * Concurrent estrogens, anti-estrogens or progesterone compounds. * Grade 2 or higher peripheral neuropathy. * Radiotherapy within 2 weeks preceding Study Day 1. * Symptomatic or clinically active brain metastases. * Major surgery within 4 weeks of Study Day 1. * Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease). * Symptomatic coronary artery disease, cerebrovascular accident,transient ischemic attack, myocardial infarction, or unstable angina pectoris within 6 months of Screening.
References
Publications (0)
Data not yet available
No reference posted for this study.