Clinical trial · Interventional
Study of Bavituximab Plus Docetaxel in Patients With Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Bavituximab Plus Docetaxel in Patients With Previously Treated Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer
NCT01138163CI-TRIAL-00027060completedPhase 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)
The primary purpose of this research study is to see whether adding bavituximab (an investigational drug) to the standard chemotherapy drug docetaxel, will improve the results of the treatment for non-small-cell lung cancer.
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 | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel plus bavituximab or placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Docetaxel plus bavituximab 1 mg/kg
- interventionNames
- Drug: Docetaxel plus bavituximab or placebo
- type
- EXPERIMENTAL
- label
- Docetaxel plus bavituximab 3 mg/kg
- interventionNames
- Drug: Docetaxel plus bavituximab or placebo
- type
- PLACEBO_COMPARATOR
- label
- Docetaxel plus placebo
- interventionNames
- Drug: Docetaxel plus bavituximab or placebo
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults over age 18 years of age with a life expectancy of at least 3 months. * Histologically or cytologically confirmed stage IIIB or stage IV non squamous non-small-cell lung cancer (NSCLC) who have progressed after 1 chemotherapy regimen. * Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST, Version 1.1) on cross-sectional imaging that is at least 2 cm in longest diameter. * Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2. * Adequate hematologic, renal, and hepatic function. * PT/INR ≤ 1.5 × ULN; aPTT time ≤ 1.5 × ULN. * New York Heart Association classification I or II Exclusion Criteria: * Squamous, small cell, or mixed histology. * Known history of bleeding diathesis or coagulopathy. * Cavitary tumors or tumors invading or abutting large blood vessels. * Bleeding: Clinically significant bleeding such as gross hematuria, GI bleeding and hemoptysis within 12 months of Screening. * Venous thromboembolic events within 6 months of screening. * Ongoing therapy with oral or parenteral anticoagulants. * Concurrent estrogens, anti-estrogens or progesterone compounds. * Radiotherapy within 2 weeks or major surgery within 4 weeks preceding Study Day 1. * Symptomatic or clinically active brain metastases. * Symptomatic coronary artery disease, cerebrovascular accident, transient ischemic attack, myocardial infarction or unstable angina pectoris within 6 months of screening. * Grade 2 or higher peripheral neuropathy
References
Publications (0)
Data not yet available
No reference posted for this study.