A Phase I/II, Open Label, Dose-Escalating Study Evaluating the Safety and Efficacy of the Anti-Epidermal Growth Factor Receptor (EGFR) Monoclonal Antibody EMD 72000 (Matuzumab) in Combination with the EGFR Tyrosine Kinase Inhibitor Tarceva (Erlotinib) in Subjects with Recurrent Advanced Non-Small-Cell Lung Cancer
- Conditions
- Stage IIIB/IV non-small cell lung cancer and progressive disease after first-line treatment with a platinum analogue in comination with taxanes, gemcitabine, or vinorelbineMedDRA version: 8.1Level: LLTClassification code 10061873
- Registration Number
- EUCTR2006-000871-13-DE
- Lead Sponsor
- Merck KGaA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
1. Signed written informed consent / written informed consent for analysis of biomarker is optional and not required for participation in the main study
2. Male or female; Age =18 years
3. Histological or cytological confirmed diagnosis of advanced NSCLC
4. Radiographic demonstrated progression during or after treatment and have Stage IIIB/IV disease initially or at time of enrollment. The subject must have received at
least 1 prior therapy for NSCLC. The first line treatment must have consisted of a platinum analogue in combination with taxanes, gemcitabine, or vinorelbine
5. At least 1 bidimensional measurable lesion according to the modified WHO criteria
6. ECOG performance status of 0, 1, or 2
7. Adequate baseline hematologic values within 1 week prior to start of active treatment defined as follows:
•Absolute neutrophil count (ANC) =1500 cells/µL
•Platelet count =100,000 cells/µL
•Hemoglobin =9.0 g/dL
8. Adequate organ functions within 1 week prior to start of active treatment defined as follows:
•Serum creatinine =1.5 x upper limit of normal (ULN)
•Total bilirubin <1.5 x ULN
•Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =2.5 x ULN (Subjects with liver metastases should have ALT/AST <5 x ULN)
9. Use of an acceptable means of contraception for men and women of childbearing potential during the treatment period and continuing 2 months after the last
dose. Subjects of procreative potential are defined as any fertile male, or any female who has experienced menarche and who is not postmenopausal (defined as age-related amenorrhea =12 months) or who has not undergone successful surgical sterilization (hysterectomy or bilateral oophorectomy)
10. Toxicity related to prior therapy must have improved to =grade 1 prior to enrollment
11. Availability of archived tumor tissue or cytologic sample
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Prior treatment with an investigational or marketed inhibitor of the EGFR pathway
2. Subject received systemic chemotherapy, radiotherapy, or investigational treatment (on or off a clinical study) within 30 days prior to treatment
3. Pregnant (confirmed by ß -HCG) or lactating female
4. Presence of a =grade 2 preexisting skin disorder (except for alopecia)
5. Weight loss >10% within 12 weeks prior to the start of study treatment
6. History of serious systemic disease, including myocardial infarction within the last 6 months, uncontrolled hypertension (blood pressure >150/100 mmHg on medication), unstable angina, New York Heart Association (NYHA) grade 2 or greater
congestive heart failure (CHF), unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible), clinically significant peripheral vascular disease or any current grade 3 or 4 cardiovascular disorder despite treatment
7. Documented history of symptomatic brain metastases
8. Previous diagnosis of autoimmune disease with significant organ involvement
9. History of drug-related acute infusion reaction
10. Inability to take oral medication or requirement for intravenous (IV) alimentation or total parenteral nutrition with lipids, or prior surgical procedures affecting absorption
11. Presence of another invasive cancer within 5 years prior to start of active treatment, except for adequately treated basal cell skin cancer, or in situ carcinoma of the cervix
12. History of significant neurologic or psychiatric disorder (e.g., dementia, seizures, or bipolar disorder) that may impair the subject's understanding of the Informed Consent Form or ability to comply with study requirements
13. History of alcohol or substance abuse as defined by the Diagnostic and Statistical Manual (DSM-IV) criteria, within 6 months prior to start of study treatment
14. Known conditions that require concurrent treatment with a nonpermitted drug
15. Presence of a contraindication to erlotinib according to the labeling for erlotinib
16. Known hypersensitivity to the study treatment or any of its components
17. Any significant disease that, in the Investigator’s opinion, should exclude the subject from the study
18. Legal incapacity or limited legal capacity
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method