A Phase 1b/2 study of AMG 655 Combination with Paclitaxel and Carboplatin for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer

Phase 1

Conditions: Stage IIIb/IV Non-Small Cell Lung Cancer
MedDRA version: 9.1Level: LLTClassification code 10029522Term: Non-small cell lung cancer stage IV
MedDRA version: 9.1Level: LLTClassification code 10029519Term: Non-small cell lung cancer stage III

Registration Number: EUCTR2006-006658-89-FR

Lead Sponsor: Amgen Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 165

Inclusion Criteria

Disease Related

• Histologically or cytologically confirmed non-small cell lung cancer. Mixed tumors will be categorized by the predominant cell type unless small cell elements are present in which case the subject will be ineligible. Cytologic or histologic elements can be established on metastatic tumor aspirates or biopsy.
• Subjects must have advanced non-small cell lung cancer defined as stage IIIB with
malignant pleural effusion or stage IV or recurrent disease (recurrent disease is defined as documented disease progression following complete surgical resection for stage I or II disease). Subjects with unmeasurable but evaluable disease can be included in the study.
• Planning to receive up to 6 cycles of chemotherapy
• Eastern Cooperative Oncology Group (ECOG) score of 0 or 1

Demographic

• Men or women = 18 years of age

Ethical

• Before any study specific procedure is performed, the appropriate approved written
informed consent must be obtained

Laboratory

• Hematological function as follows:
- Hemoglobin = 9 g/dL
- Absolute neutrophil count = 1.5 x 109/L
- Platelet count = 100 x 109/L (without a transfusion = 14 days prior to enrollment or randomization)
• Renal function, as follows:
- Calculated creatinine clearance = 40 mL/minute
• Hepatic function, as follows:
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) = 2.5 x ULN
OR AST or ALT = 5.0 x ULN if clearly attributable to liver metastasis
- Total bilirubin = 1.5 x ULN
- Alkaline phosphatase = 2.0 x ULN OR alkaline phosphatase = 5 x ULN if liver or bone metastases are present
• Partial thromboplastin (PTT) = 1.0 x ULN and international normalized ratio (INR) = 1.5, unless subject is on anti-coagulation therapy. Subjects on therapeutic anti-coagulation are eligible if there is no bleeding and they are on a stable dose of anticoagulation therapy (eg, warfarin with an INR of 2 to 3) for at least 7 days before
enrollment/randomization.
• Amylase = 2 x ULN
• Lipase = 2 x ULN

General
• Plan to begin protocol specific therapy = 7 days prior to enrollment/randomization
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

Exclusion Criteria

Disease Related

• Untreated or symptomatic central nervous system metastases. Subjects with a history of brain metastases are eligible if definitive therapy has been administered (surgery and/or radiation therapy), there is no planned treatment for brain metastasis and the subject is clinically stable and off corticosteroids for at least 14 days before enrollment/randomization.
• Prior chemotherapy as follows:
• Any prior chemotherapy for advanced non-small cell lung cancer
• Any prior adjuvant chemotherapy for non-small cell lung cancer = 52 weeks prior to
enrollment/randomization. Adjuvant chemotherapy completed > 52 weeks prior to
randomization is permitted.
• Any prior chemoradiation.
• Central (chest) radiation therapy = 28 days prior to randomization, radiation therapy for peripheral lesions = 14 days prior to enrollment/randomization
• A history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for = 3 years.
• Other abnormal medical conditions
• Documented myocardial infarction or unstable/uncontrolled cardiac condition (eg,
unstable angina, congestive heart failure [New York Heart Association > Class II])
= 52 weeks prior to enrollment/randomization
• History of arterial thrombosis, pulmonary embolus, deep vein thrombosis or hemorrhagic disorders = 28 days prior to enrollment/randomization
• History of any medical or psychiatric condition or addictive disorder, or laboratory
abnormality that in the opinion of the investigator, may increase the risks associated with study participation or study treatments or may interfere with the conduct of the study or interpretation of study results
• Major surgical procedure = 30 days prior to enrollment/randomization or not yet
recovered from prior major surgery
• Minor surgical procedure = 7 days prior to enrollment/randomization or not yet recovered from prior minor surgery
• Known positive test for human immunodeficiency virus, hepatitis C virus or acute or
chronic hepatitis B infection
• Any co-morbid disease that would increase the risk of toxicity

Medications and other treatments

• Currently treated or previously treated with biologic, small molecule, immunotherapy, or other agents to treat advanced non-small cell lung cancer
• Recent infection requiring a course of systemic anti-infectives that was completed
= 7 days before enrollment/randomization (with the exception of uncomplicated urinary tract infection)
• Yellow fever vaccination within 30 days of randomization

General

• Subject is not able to tolerate intravenous drug infusions
• Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s)
• Subject of child-bearing potential is evidently pregnant or is breast feeding
• Woman or man with partner of childbearing potential not consenting to use adequate contraceptive precautions ie double barrier contraceptive methods (eg diaphragm plus condom), or abstinence during the course of the study and for 6 months after the last study drug administration for women, and 1 month for men
• Subject has known sensitivity to any of the products to be administered during the study
• Subject was previously enrolled/randomized in this study
• Subject will not be available for follow-up assessment
• Subject has any kind of

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

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