Stage IIIb/IV Non-Small Cell Lung Cancer MedDRA version: 9.1 Level: LLT Classification code 10029519 Term: Non-small cell lung cancer stage III MedDRA version: 9.1 Level: LLT Classification code 10029522 Term: Non-small cell lung cancer stage IV
Conditions
Interventions
Product Name: AMG 655
Product Code: AMG 655
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: AMG 655
Current Sponsor code: AMG 655
Concentration unit: mg/kg milligram(s)/kilogram
Concent
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
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 non-measurable 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 The following results must be obtained within 7 days before enrollment/randomization unless indicated otherwise: • 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) = 1.2 x ULN and international normalized ratio (INR) = 1.5, unless subject is on anti-coagulation therapy. Subjects on therapeutic anticoagulation are eligible if there is no bleeding and they are on a stable dose of anticoagulation therapy (eg, on warfarin with an INR of 2 to 3) for at least 14 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
Exclusion criteria: Disease Related • Untreated or symptomatic central nervous system metastases. - Subjects with a history of CNS metastases that are both definitively treated and stably controlled are eligible if all of the following apply: 1)definitive therapy has been administered (surgery and/or radiation therapy); 2) there is no additional treatment planned for brain metastases; 3) the subject is clinically stable; 4) the subject is off corticosteroids or on a stable dose of corticosteroids for at least 14 days prior to enrollment/randomization• • Prior chemotherapy as follows: - Any prior chemotherapy for advanced non-small cell lung cancer - Any prior adjuvant or neo-adjuvant chemotherapy for non-small cell lung cancer = 52 weeks prior to enrollment/randomization. Adjuvant or neoadjuvant chemotherapy completed > 52 weeks prior to randomization is permitted. - Any prior chemoradiation for non-small cell lung cancer. • 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: curatively treated non-melanoma skin cancer, in-situ cancer of the cervix, or other in situ cancer with similarly favorable prognosis) unless treated with curative intent, with no treatment administered and without 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 3 months after the la
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part 1 (Phase 1b): To determine the maximum tolerated dose up to a target dose of 15 mg/kg of AMG 655 that can be administered in combination with paclitaxel/carboplatin Part 2 (Phase 2): To estimate the efficacy of AMG 655 as assessed by progression free survival time (at two doses selected in part 1) in combination with paclitaxel/carboplatin;Secondary Objective: Part 1: To evaluate the safety and tolerability of escalating doses of AMG 655 in combination with paclitaxel/carboplatin To evaluate parameters of clinical benefit as measured by objective response rate, duration of response, time-to-response, progression-free survival and overall survival To evaluate the pharmacokinetics of AMG 655 To evaluate anti-AMG 655 antibody formation Part 2: To estimate the clinical benefit of AMG 655 in combination with paclitaxel/carboplatin as measured by overall objective response rate, duration of response, time-to-response and overall survival To evaluate the safety and tolerability of AMG 655 in combination with paclitaxel/carboplatin To evaluate the pharmacokinetics of AMG 655 To evaluate anti-AMG 655 antibody formation;Primary end point(s): Part 1: The incidence of adverse events and clinical laboratory abnormalities defined as dose limiting toxicities Part 2: Progression free survival | — |
Countries
Belgium, France, Hungary, Spain, United Kingdom
Outcome results
None listed