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Open, Randomized, Multinational Phase IIIb Trial Evaluating the Activity and Safety of Cetuximab as 250 mg/m2 Weekly and 500 mg/m2 Every Two Weeks Maintenance Therapy After Platinum-based Chemotherapy in Combination With Cetuximab as First-line Treatment for Subjects With Advanced Non-small Cell Lung Cancer (NSCLC).


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer (NSCLC)

Thank you

Trial Information

Open, Randomized, Multinational Phase IIIb Trial Evaluating the Activity and Safety of Cetuximab as 250 mg/m2 Weekly and 500 mg/m2 Every Two Weeks Maintenance Therapy After Platinum-based Chemotherapy in Combination With Cetuximab as First-line Treatment for Subjects With Advanced Non-small Cell Lung Cancer (NSCLC).


Inclusion Criteria:



For inclusion in the trial, all of the following inclusion criteria must be fulfilled:

- Subject has given written informed consents before any trial-related activities are
carried out

- Male or female, ≥18 years of age at the time of informed consent, inpatient or
outpatient

- Diagnosis of histologically or cytologically confirmed NSCLC, stage IIIB NSCLC with
pleural effusion or stage IV

- Presence of at least 1 uni-dimensionally measurable index lesion, whereby index
lesions must not lie in a previously irradiated area

- ECOG performance status of 0 or 1 at inclusion in the trial

- White blood count ≥3 x 10^9/L with neutrophils ≥1.5 x 10^9/L, platelet count ≥100 x
10^9/L, and hemoglobin ≥5.6 mmol/L (9 g/dL)

- Total bilirubin ≤1.5 x upper limit of normal (ULN) range

- Aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) ≤5 x ULN

- Glomerular filtration rate (GFR) ≥60 mL/min. The creatinine clearance estimated by
the Cockroft-Gault formula will be used as a surrogate for the GFR

- Effective contraception i.e., barrier method (condoms, diaphragm), oral, injectable
or implant birth control, for both male and female subjects during the whole trial
period and for at least 6 months after the end of trial treatment, if the risk of
conception exists

- Recovered from relevant toxicities prior to inclusion in the trial

Exclusion Criteria:

Subjects are not eligible for this trial if they fulfill any of the following exclusion
criteria:

- Previous exposure to EGFR-targeting therapy

- Previous chemotherapy for NSCLC; neo-adjuvant or adjuvant (radio-)chemotherapy is
allowed if it was finished 6 months prior to start of trial treatment

- Major surgery within 30 days prior to inclusion in the trial

- Prior chest irradiation within 90 days prior to inclusion in the trial (palliative
radiation of bone lesions is allowed)

- Participation in another clinical trial or treatment with any investigational
agent(s) within 30 days prior to inclusion in the trial

- Concurrent chronic systemic immune therapy, chemotherapy for disease other than
cancer, or hormone therapy for the treatment of cancer not indicated in the trial
protocol

- Documented or symptomatic brain metastasis

- Pre-existing ascites Grade ≥2 and/or pericardial effusion Grade ≥2

- Superior vena cava syndrome contra-indicating hydration

- Previous malignancy in the last 5 years except basal cell carcinoma of the skin or
pre-invasive carcinoma of the cervix

- Active infection (infection requiring intravenous [IV] antibiotics), including active
tuberculosis, known and declared human immunodeficiency virus (HIV)

- Myocardial infarction within 6 months prior to inclusion into the trial, uncontrolled
congestive heart failure; or any current Grade 3 or 4 cardio-vascular disorder
despite treatment

- Known hypersensitivity reaction to any of the components of trial treatments

- Symptomatic peripheral neuropathy National Cancer Institute-Common Toxicity Criteria
(NCI-CTC) Grade ≥2 and/or ototoxicity Grade ≥2, except if due to trauma or mechanical
impairment due to tumor mass

- History of significant neurologic or psychiatric disorders including dementia,
seizures, bipolar disorder

- Medical or psychological condition that would not permit the subject to complete the
trial or sign informed consent

- Legal incapacity or limited legal capacity

- Known drug abuse

- Pregnancy (absence to be confirmed by serum β-HCG test) or lactation period

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival (OS) Time

Outcome Description:

Time from trial inclusion to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is earlier.

Outcome Time Frame:

Time from trial inclusion to death, reported between day of first patient included, Jan 2009, until cut off date.

Safety Issue:

No

Principal Investigator

Steffen Heeger, MD MSc

Investigator Role:

Study Director

Investigator Affiliation:

Merck KGaA

Authority:

Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Study ID:

EMR 62240-506

NCT ID:

NCT00820755

Start Date:

January 2009

Completion Date:

December 2012

Related Keywords:

  • Non-Small Cell Lung Cancer (NSCLC)
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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