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

Lilly

Status and phase

Completed

Phase 2

Conditions

Non-Small-Cell Lung Carcinoma

Lung Neoplasms

Cancer of the Lung

Carcinoma

Treatments

Drug: Cetuximab

Drug: Vinorelbine

Drug: Cisplatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01109524

CA225-346

Details and patient eligibility

About

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.

Enrollment

72 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion 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

Exclusion 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