Clinical trial · Interventional
A Study of MetMAb Administered to Patients With Advanced Non-Small Cell Lung Cancer, in Combination With Tarceva (Erlotinib)
A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Activity of MetMAb, a Monovalent Antagonist Antibody to the Receptor Met, Administered to Patients With Advanced Non-Small Cell Lung Cancer, in Combination With Tarceva (Erlotinib)
- 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 Phase II, double-blind, randomized, multicenter trial designed to preliminarily evaluate the activity and safety of treatment with MetMAb + erlotinib versus erlotinib + placebo in second- and third-line Non-Small Cell Lung Cancer (NSCLC). Up to 180 patients will be randomized in a 1:1 ratio to one of the two treatment arms.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erlotinib HCl | Drug | Erlotinib Hydrochloride | ALIAS |
| MetMAb | Drug | Onartuzumab | ALIAS |
| placebo (0.9 % saline) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MetMAb + Erlotinib
- description
- MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
- interventionNames
- Drug: Erlotinib HCl
- Drug: MetMAb
- type
- PLACEBO_COMPARATOR
- label
- Placebo + Erlotinib
- description
- Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
- interventionNames
- Drug: Erlotinib HCl
- Drug: placebo (0.9 % saline)
Primary outcomes (2)
- measure
- Progression-free Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Patients must meet the following criteria for study entry: * Histologically confirmed NSCLC * Availability of a tumor specimen * Recurrent or progressive disease following at least one chemo containing regimen for Stage IIIB/IV disease * Measurable disease in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) * At least one measurable lesion on a pre-treatment 18-fluorodeoxyglcose-positron emission tomography (FDG-PET) scan that is also a target lesion on computed tomography (CT) according to RECIST Exclusion Criteria: * More than two prior treatments for Stage IIIB/IV * More than 30 days of exposure to an investigational or marketed agent that can act by EGFR inhibition, or a known epidermal growth factor receptor (EGFR)-related toxicity resulting in dose modifications * Chemotherapy, biologic therapy, radiotherapy or investigational drug within 28 days prior to randomization * Untreated and/or active (progressing or requiring anticonvulsants or corticosteroids for symptomatic control) central nervous system (CNS) metastasis * History of serious systemic disease within the past 6 months prior to randomization * Uncontrolled diabetes * Major surgical procedure or significant traumatic injury within 28 days prior to randomization * Anticipation of need for a major surgical procedure during the course of the study * Local palliative radiotherapy within 7 days prior to randomization or persistent adverse effects from radiotherapy that have not been resolved to Grade II or less prior to randomization * Symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
References
Publications (0)
Data not yet available