A Multicenter, Open Label, Randomized Study of AMG 951 in Subjects with Previously Untreated Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC) Treated with Chemotherapy with or without Bevacizumab - 20050190

• Conditions: Treatment of patients with stage IIIb/IV non-small cell lung cancer; MedDRA version: 14.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2005-005484-28-IT
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-11
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

Histologically or cytologically confirmed Non-Small Cell Lung Cancer (NSCLC). Mixed tumors will be categorized by the predominant cell type unless small cell elements are present in which case the patient is ineligible. Cytologic or histologic elements can be established on metastatic tumor aspirates or biopsy. • Subjects must have advanced NSCLC defined as stage IIIb with malignant pleural effusion or Stage IV or recurrent disease. Subjects with non-measurable but evaluable disease can be included in the phase 1b study, but disease must be measurable to be included in the phase 2 study • Planning to receive up to 6 cycles of chemotherapy • ECOG performance status of 0 or 1 • Life expectancy greater than 3 months • `?¥ 18 years old • Subjects must sign and date a written Independent Ethics Committee (IEC)-approved Informed Consent Form • International Normalization Ratio (INR) `?¤ 1.2 and PTT `?¤ ULN within 1 week prior to enrollment
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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

Prior malignancy other than NSCLC (except in situ basal cell carcinoma or in situ cervical cancer), unless have been treated with curative intent with no evidence of disease for `?¥ 3 years • Untreated or unstable central nervous system (CNS) metastases. Subjects with CNS metastases that are both definitively treated and stably controlled are eligible for cohorts A and B of the phase 2 part of the study 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 2 weeks prior to enrollment • Myocardial infarction, or unstable or uncontrolled disease or condition related to or impacting cardiac function (eg, unstable angina, congestive heart failure [New York Heart Association > class II]) within 1 year of enrollment • Uncontrolled hypertension defined as: systolic blood pressure `?¥ 150 mm Hg OR diastolic blood pressure `?¥ 100 mm Hg (antihypertensive therapy to achieve these parameters is allowable) • History of arterial thrombosis, pulmonary embolus, deep vein thrombosis or hemorrhagic disorders within 1 year of enrollment - Recent major surgical procedure within 28 days prior to enrollment or not yet recovered from prior major surgery (For the full list see protocol.)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the objective response rate (Complete Response (CR) and Partial Response (PR)) by modified RECIST for AMG 951 at varying dose schedules in combination with carboplatin / paclitaxel ± bevacizumab for subjects with NSCLC.;Secondary Objective: To evaluate overall response rate (CR, PR and Stable Disease (SD)), progression-free survival (PFS), time to response, duration of response, time to progression (TTP) and overall survival for AMG 951 at varying dose schedules. To evaluate the safety profile of AMG 951 at varying dose schedules. To evaluate the formation of anti-AMG 951 antibodies. To characterize the pharmacokinetics of AMG 951;Primary end point(s): Objective response rate (complete or partial response)