Clinical trial · Interventional
Avastin and Tarceva for Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer
Safety and Efficacy of Recombinant Humanized Monoclonal Anti-VEGF Antibody rhuMAb VEGF and EGFR Tyrosine Kinase Inhibitor OSI-774 for Locally Advanced or Metastatic Non-Squamous Cell NSCLC in Patients Who Have Been Previously Treated
- 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)
Primary Objectives: 1. (Phase I) To establish the maximum tolerated dose and dose-limiting toxicities of the combination of OSI-774 (Tarceva™) and rhuMAb VEGF (Avastin™) in patients with advanced Non-small-cell lung carcinoma (NSCLC). 2. (Phase II) To assess response rate and tolerability of the regimen at the dose level established in the phase I portion of this study. Secondary Objectives: 1. (Phase I and II) To evaluate the pharmacokinetic interaction between the combination. 2. (Phase I) To establish a phase II regimen of the OSI-774/ rhuMAb VEGF combination, for further study alone or in combination with cytotoxic chemotherapy.
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Avastin | Drug | Bevacizumab | ALIAS |
| Tarceva | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Avastin + Tarceva
- description
- Combination Therapy (Avastin + Tarceva) = Avastin IV Day 1 of each 21-day cycle + oral Tarceva daily.
- interventionNames
- Drug: Avastin
- Drug: Tarceva
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD) of Tarceva in combination with Avastin
- timeFrame
- After each 21 day cycle
Secondary outcomes (1)
- measure
- Response in Patients With NSCLC Receiving Combination Avastin and Tarceva
- timeFrame
- 6 weeks (2 cycles)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient has histologically proven stage IIIB with pleural effusion, stage IV or recurrent non-squamous NSCLC. * Patient has a Karnofsky performance status \>=70%. * Patient has adequate bone marrow function: WBC \>= 3,000 cells/mm3, ANC \>= 1,500 cells/mm3, platelet count \>= 100,000 cells/mm3, Hgb \>= 9.0 g/dL. * Patient has adequate liver function: total bilirubin level \<= 2.0 mg/dL, albumin \>= 2.5 g/dL. * Transaminases (aspartate aminotransferase (AST or SGOT) and/or alanine aminotransferase (ALT or SGPT)) and alkaline phosphatase may be up to 2.5 x ULN. * Patient has adequate renal function: a serum creatinine \< 2 mg/dl * Patient has signed a written informed consent. * Patient has received at least one prior chemotherapeutic regimen for recurrent or metastatic disease. Exclusion Criteria: * Patient has not received prior chemotherapeutic regimens for advanced disease. * Patient has received prior biologic therapy targeting epidermal growth factor receptor (EGFR) and/or Vascular endothelial growth factor (VEGF). * Patient has received radiation therapy within the past 3 weeks. * Patient has signs or symptoms of acute infection requiring systemic therapy. * Patient exhibits confusion, disorientation, or has a history of major psychiatric illness that may impair patient's understanding of the informed consent. * Patient requires total parenteral nutrition with lipids. * Patient has a history of uncontrolled heart disease and/or uncontrolled hypertension (\> 150/100 mmHg). * Because of the possible teratogenic effect, pregnant women and women who are currently breast-feeding may not participate in this study. - All women of childbearing potential must have a negative pregnancy test within 24 hours prior to enrolling in the study. * Serious infection or other intercurrent illness requiring immediate therapy. * Clinical/imaging evidence of Central Nervous System (CNS) malignancy or with recently treated CNS malignancy, as well as those experiencing recent cerebrovascular accident (CVA), or other CNS bleeding. * Pediatric patients in whom open growth plates would be expected. * Urine protein qualitative value of \> 30 in urinalysis or \> +1 in proteinuria testing by dipstick. * Patient has a clinical history of coagulopathy or thrombosis. * Patient is currently receiving or intending to receive anti-coagulants. * Patient has had a recent myocardial infarction (still inside the healing period). Note: a six-month window is optimal. * Patient is recovering from recent major surgery (e.g., less than 2 weeks since surgery) or is anticipating major surgery. * Patient has a clinical history of hemoptysis or hematemesis. * Patient may not have percutaneous endoscopic gastrostomy (PEG) or gastrostomy (G) tube.
References
Publications (0)
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