Clinical trial · Interventional
Study of Bevacizumab and Erlotinib in Patients With Advanced Non-small Cell Lung Cancer
Phase II Study of Bevacizumab and Erlotinib in Elderly Patients With Advanced Non-Small Lung Cancer
NCT00553800CI-TRIAL-00059619NSCLCcompletedPhase 2Results postedClinicalTrials.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 study will evaluate the combination of bevacizumab and erlotinib in elderly patients with advanced 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 |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Drug | Bevacizumab | ALIAS |
| Erlotinib | Drug | Erlotinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bevacizumab & Erlotinib
- description
- bevacizumab 15 mg/kg intravenous every three weeks and erlotinib pill 150 mg by mouth every day
- interventionNames
- Drug: bevacizumab
- Drug: Erlotinib
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)
- timeFrame
- 3 years
- description
- Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Cytologically or histologic confirmed non-small cell lung cancer, stage IIIB or IV or recurrent after primary surgery or radiotherapy. * ECOG PS 0-1 * 70 years of age or older * Must have measurable disease * ANC \> 1500, platelets \> 100,000 * Total bilirubin \</= 1.5, SGOT \* SGPT \< 5 x ULN * Able and willing to swallow and absorb oral medication * Able and willing to sign consent * Request archival diagnostic tissue for EGFR expression but not required Exclusion Criteria: * Proteinuria as demonstrated by UPC ratio \>/= 1.0 * Prior treatment with an investigational or marketed inhibitor of the EGFR pathway or anti-angiogenesis agent (includes thalidomide) * Prior treatment for advanced stage disease, with the exception of surgery or radiation (no systemic) * History of gross hemoptysis within 1 month of enrollment unless treated with surgery or radiation * Evidence of bleeding diathesis or coagulopathy or other serious/acute internal bleeding within 6 months of enrollment. * Current, ongoing treatment with full dose warfarin or equivalent * Current(within 10 days)use of aspirin (\> 325mg/day) or other NSAID with antiplatelet activity * History of hemorrhagic or thrombotic stoke, TIA, or other CNS bleeding w/in last 6 months. Clinically significant PVD * Known CNS disease except for treated brain mets. * Squamous cell histology * Blood pressure \> 150/100 that cannot be ameliorated with standard anti-hypertensives * History of hypertensive crisis or hypertensive encephalopathy * NYHA grade II or \> CHF * History of MI within 6 months of enrollment * Major surgery, open biopsy, significant trauma within 28 days of enrollment * Pregnancy, lactation * Abdominal or other fistula, abcess, perforation
References
Publications (1)
- BACKGROUNDPhase II study of bevacizumab and erlotinib in treatment-naïve elderly patients (older than age 65) with advanced non-small cell lung cancer (NSCLC). H. Borghaei, R. Mehra, M. M. Millenson, H. Tuttle, K. Ruth, A. J. Magdalinski, D. M. Mintzer, J. W. Lee, G. R. Simon, and C. J. Langer Journal of Clinical Oncology 2010 28:15_suppl, e18019-e18019