Status:
COMPLETED
Trial With Cetuximab in Maintenance Therapy After Platinum Based Chemotherapy in First Line Treatment of Non-small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Conditions:
Non-Small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This open-label, randomized, multinational, non-comparative, phase IIIb trial with 2 parallel groups will screen about 1400 subjects with stage IIIB non-small cell lung cancer (NSCLC) with pleural eff...
Eligibility Criteria
Inclusion
- Subject has given written informed consent before any trial-related activities are carried out
- Male or female, greater than or equal to (\>=)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
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at inclusion in the trial
- White blood count\>= 3 \* 10\^9 per liter (/L) with neutrophils \>= 1.5 \* 10\^9 /L , platelet count \>=100 \* 10\^9 /L , and hemoglobin \>= 5.6 millimole per liter (mmol/L) (9 gram per deciliter \[g/dL\])
- Total bilirubin less than or equal to (=\<)1.5 \* upper limit of normal (ULN) range
- Aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) =\< 5 \* ULN
- Glomerular filtration rate (GFR) \>=60 milliliter per minute (mL/min). The creatinine clearance (CrCl) estimated based on the Cockroft-Gault formula is used as a surrogate for the GFR
- Effective contraception that is, 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
- Previous exposure to Epidermal Growth Factor Receptor (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 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 beta-human chorionic gonadotropin \[beta-HCG test\]) or lactation period
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
583 Patients enrolled
Trial Details
Trial ID
NCT00820755
Start Date
January 1 2009
End Date
June 1 2013
Last Update
May 5 2014
Active Locations (1)
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1
Central Contact
Darmstadt, Germany