Clinical trial · Interventional
Combination of Erlotinib and Bevacizumab as Second-line Treatment in Patients With Non-small Cell Lung Cancer
Combination of Erlotinib (Tarceva®) and Bevacizumab (Avastin®) as Second-line Treatment in Locally Advanced / Metastatic, Non-squamous, Non-small Cell Lung Cancer (NSCLC) Patients: A Phase II Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor accrual
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the efficacy and toxicity of combination of erlotinib and bevacizumab in patients with locally advanced or metastatic, non-squamous non-small cell lung cancer, who progressed after first line treatment. Pretreatment with one of the two agents would not excluded patients from the study, in order to evaluate whether the combination of the two biologic agents could reverse tumor resistance.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Erlotinib | Drug | Erlotinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Erlotinib/Bevacizumab
- interventionNames
- Drug: Erlotinib
- Drug: Bevacizumab
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- Objective responses confirmed by CT or MRI (on 3rd and
Secondary outcomes (4)
- measure
- Progression Free Survival
- timeFrame
- 1 year
- measure
- Overall Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed, unresectable locally advanced (stage IIIB with pleural effusion) and/or metastatic (stage IV) NSCLC * Progression to first-line therapy for advanced/metastatic NSCLC * Bi-dimensionally measurable disease (not included in radiation field) * ECOG performance status of 0-2 * Life expectancy of more than 6 months * Adequate liver (serum bilirubin \<1.5 times the upper normal limit, AST and ALT \<2.5 times the upper normal limit in the absence of demonstrable liver metastases, or \<5 times the upper normal limit in the presence of liver metastases,adequate renal function (serum creatinine \<1.5 times the upper normal limit),and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function * Signed informed consent Exclusion Criteria: * Central nervous system involvement (unless if the patient has being previously irradiated and is clinically stable) * Presence of a centrally located mass or a tumor mass in close relation to large vessels or a mass with cavitation. * Surgery or radiation therapy within the last 14 days from study entry * Active infection * History of life-threatening hemoptysis / hematemesis, history of thrombosis or use of anti-coagulation therapy * History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction, ventricular arrhythmias) or stroke within the previous 6 months or uncontrolled hypertension * Patients on other experimental treatment protocols * History of a second primary malignancy (other than basal-cell skin carcinoma or in situ carcinoma of the cervix) * Psychiatric illness or social situation that would preclude study compliance * Pregnant or lactating women
References
Publications (0)
Data not yet available