Clinical trial · Interventional
Ph II of a Novel Anti-angiogenic Agent in Combination With Chemotherapy for the Treatment of Non-Small Cell Lung Cancer
A Randomized Double-Blinded Phase II Study of Carboplatin/Paclitaxel/CT-322 Versus Carboplatin/Paclitaxel/Bevacizumab as First-Line Treatment for Recurrent or Advanced Non-Small Cell Lung Cancer With Non-Squamous Histology
NCT00850577CI-TRIAL-00019431terminatedPhase 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 purpose of this study is to determine the efficacy of CT-322 comparative to bevacizumab, both in combination with carboplatin and paclitaxel in the treatment of chemonaive subjects with recurrent or advanced non-squamous 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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Bevacizumab placebo (ie saline solution) | Drug | — | UNRESOLVED |
| Carboplatin | Drug | Carboplatin | ALIAS |
| CT-322 | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Paclitaxel/Carboplatin/CT-322
- interventionNames
- Drug: Paclitaxel
- Drug: Carboplatin
- Drug: CT-322
- type
- ACTIVE_COMPARATOR
- label
- Paclitaxel/Carboplatin/Bevacizumab/Placebo
- interventionNames
- Drug: Paclitaxel
- Drug: Carboplatin
- Drug: Bevacizumab
- Drug: Bevacizumab placebo (ie saline solution)
Primary outcomes (1)
- measure
- Progression free survival based on tumor assessments (CT scans/MRI)
- timeFrame
- every 6 weeks until documented progressive disease , death or initiation of subsequent therapy for NSCLC
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation. Inclusion Criteria: * ECOG Performance Status (PS) \<=1 * Histologically or cytologically confirmed, stage IIIB (malignant pleural effusion), stage IV or recurrent NSCLC * Measurable disease by RECIST guidelines Exclusion Criteria: * Evidence of predominantly squamous-cell histology * Known CNS metastases * Any prior antineoplastic systemic regimens for NSCLC * Excessive risk of bleeding (including use of therapeutic anticoagulation) and history of thrombotic or embolic cerebrovascular accident * Gross hemoptysis (≥1/2 tsp of red blood) * Uncontrolled hypertension * Clinically significant cardiovascular disease * History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months * Serious non-healing wound, active peptic ulcer, non-healing bone fracture, or bleeding skin metastasis
References
Publications (0)
Data not yet available
No reference posted for this study.