Clinical trial · Interventional
Bavituximab Plus Carbo and Pemetrexed in Chemo-Naive Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Subjects
A Phase 1b Study of Bavituximab Plus Carboplatin and Pemetrexed in Chemotherapy-Naive Stage IV Non-Squamous Non-Small Cell Lung Cancer
NCT01323062CI-TRIAL-00036008completedPhase 1ClinicalTrials.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 non-randomized, open-label Phase 1b trial to establish the safety and recommended phase 2 dose (RP2D) of bavituximab in combination with pemetrexed and carboplatin in subjects with previously untreated stage IV non-squamous 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 Small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bavituximab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Single-arm trial
- description
- Single-arm trial
- interventionNames
- Drug: Bavituximab
Primary outcomes (1)
- measure
- Measure number of severe side effects seen during first cycle of therapy
- timeFrame
- Three weeks
- description
- To determine the maximum tolerated dose based on occurrence of dose-limititing toxicity (DLT) within the first 3 weeks of treatment to determine appropriate and safe dose of bavituximab in combination with carboplatin and pemetrexed
Secondary outcomes (1)
- measure
- Progression free survival
- timeFrame
- At the time from the start of treatment until documented disease as defined bia RECIST 1.1 or death
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Greater than or equal to 18 * Histologically or cytologically confirmed stage IV non-squamous NSCLC not previously treated with systemic chemotherapy * Evaluable disease by clinical or radiographic parameters * No history or concomitant malignancy * Adequate organ and marrow function * Female subjects with negative urine or serum pregnancy * ECOG must be 0 or 1 Exclusion Criteria: * Squamous cell, small cell, or mixed histology * Known history of bleeding diathesis or coagulopathy * Cavitary tumors or tumors invading or abutting large blood vessels * Any history of thromboembolic events * Ongoing therapy with oral or parenteral anticoagulants * Major surgery within 4 weeks of Day 1 of treatment * Uncontrolled intercurrent disease (diabetes, hypertension, thyroid disease) * any history of significant vascular disease * Congestive heart failure * History of any condition requiring anti-platelet therapy * Serious non healing wound * Known chronic infection with human immunodeficiency virus (HIV) or viral hepatitis * Unable or unwilling to discontinue use of prohibited medications * D-dimers \>2 x ULN as measured on 2 separate occasions at least 1 day apart
References
Publications (0)
Data not yet available
No reference posted for this study.