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CompletedPhase 2NCT01109524
Official study title

Safety Study of Cetuximab in Combination With Cisplatin and Vinorelbine to Treat Advanced Non-small Cell Lung Cancer

Study summary

The purpose of the study is to determine if U.S. manufactured Cetuximab can be safely used for the treatment of Non-Small Cell Lung Cancer in combination with Cisplatin and Vinorelbine.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCetuximab and Cisplatin

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 24, 2015 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?22 U.S. locations

Locations may change over time.

Who runs it?Eli Lilly and Company

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Eli Lilly and Company
Interventions being studied
Drug: Cetuximab; Drug: Cisplatin; Drug: Vinorelbine
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Treatment approach
Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Non-Small Cell Lung Cancer (NSCLC), Stage IV (per the American Joint Committee on Cancer (AJCC) Staging Manual, Seventh Edition) or recurrent disease following surgery and/or radiation therapy
  • Evaluable or measurable disease
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Reasons someone may not be able to joinExclusion criteria
  • Uncontrolled Central Nervous System (CNS) metastasis.
  • Previous exposure to monoclonal antibodies, signal transduction inhibitors or Epidermal growth factor receptor (EGFR) targeting therapy
  • Concurrent malignancy
  • Prior chemotherapy for NSCLC
  • Pre-existing ascites grade ≥ 2 or pericardial effusion grade ≥ 2
  • Superior vena cava syndrome contra-indicating hydration
  • White Blood Cells (WBC) \< 3,000/mm³
  • Absolute neutrophile count (ANC) \< 1,500/mm³
  • Platelet \< 100,000/mm³
  • Hemoglobin (Hgb) \< 9.0 g/dL
  • Total bilirubin \> 1.5 x Upper limit of normal (ULN).
  • Aspartate aminotransferase (AST) or Alanine-aminotransferase (ALT) \> 5.0 x ULN.
  • Serum creatinine \>1.25 x ULN and calculated creatinine clearance \<60mL/min

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Donald W. Hill M.D., P.C.Casa Grande, Arizona
  • Beverly Hills Cancer CenterBeverly Hills, California
  • Cancer Care InstituteLos Angeles, California
  • Northern California Hematology & OncologyOakland, California
  • Sharp Clinical Oncology ResearchSan Diego, California
  • Broward Oncology Associates, P.A.Fort Lauderdale, Florida
  • Elite Research InstituteMiami, Florida
  • Edward H. Kaplan, MD & AssociatesSkokie, Illinois
  • Fairview Southdale Medical Oncology ClinicEdina, Minnesota
  • Mid Dakota Clinic, PcBismarck, North Dakota
  • Temple University HospitalPhiladelphia, Pennsylvania
  • University Medical CenterLubbock, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 24, 2015. Always confirm current availability with the study team.

View original record ↗