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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

Phase 2
18 Years
Not Enrolling
Non-Small Cell Lung Cancer

Thank you

Trial Information

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

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 unmeasurable 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

- INR ≤ 1.2 and PTT ≤ ULN within 1 week prior to enrollment

Exclusion Criteria:

Disease Related

- 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 treated
and stably controlled CNS metastases are eligible for cohorts A and B of the phase 2
part of the study if definitive therapy has been administered (surgery and/or
radiation therapy), there is no planned treatment for brain metastases, and the
subject is clinically stable and 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 (e.g., 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 of enrollment

- Subjects must not have serious non-healing wound ulcer, or bone fracture within 21
days prior to enrollment

- Persistent history of gross hemoptysis (defined as bright red blood of a ½ teaspoon
or more) related to subject's NSCLC

- Known (documented in medical notes) HIV infection

- Active infection on day of enrollment

- Known to be hepatitis C positive OR hepatitis B surface antigen positive

- Subjects with Gilbert's syndrome


- Absolute neutrophil count (ANC) < 1.5 x 10*9 /L (without granulocyte-colony
stimulating factor support within 2 weeks of enrollment)

- Platelet count < 100 x 10*9 /L (without transfusion within 2 weeks of enrollment)

- Hemoglobin < 9 g/dL (subjects may be transfused or receive erythropoietic treatment
to meet criterion)

- Urine protein quantitative value of > 1+ on dipstick or > 30 mg/dL in urinalysis. If
quantitative protein is < 500 mg in 24-hour urine collection then subject can be

- Significant liver dysfunction as defined by aspartate aminotransferase (AST) or
alanine aminotransferase (ALT) > 2.5 x upper limits of normal (ULN)

- Alkaline phosphatase > 2.5 x ULN, or alkaline phosphatase > 5 x ULN in the presence
of bone or liver metastasis

- Total bilirubin > 1.5 x ULN

- Calculated creatinine clearance < 50 mL/min.

- Hypercalcemia (serum calcium > 12.0 mg/dL or symptomatic)


- Prior chemotherapy (except for adjuvant chemotherapy, provided the last dose of
adjuvant therapy was received at least one year prior to enrollment), hormonal
therapy, radiotherapy (except palliative radiotherapy for bone metastases or
radiation therapy for CNS metastases) or immunotherapy for treatment of advanced

- Prior drug treatment or therapy with investigational agents for NSCLC

- Therapeutic anticoagulation treatment. Prophylactic anticoagulation of venous access
devices (eg, with low-dose warfarin [1-2mg/day] or low-dose heparin) is allowed
providing INR ≤ 1.2 and PTT is ≤ ULN within 1 week prior to enrollment

- Chronic daily treatment with aspirin (> 325 mg/day) or non-steroidal
anti-inflammatory agents known to inhibit platelet function. Treatment with
dipyridamole, ticlopidine, clopidogrel and/or cilostazol is also not allowed.

General Exclusions

- Participation in clinical trials or undergoing other investigational procedures
within 30 days before study enrollment

- Subject is evidently pregnant (e.g. positive HCG test) or is breast feeding

- Woman or man with partner of childbearing potential not consenting to use adequate
contraceptive precautions i.e. 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

- Subject has any kind of disorder that compromises the ability of the subject to give
written informed consent and/or comply with study procedures.

- Any condition which in the investigator's opinion makes the subject unsuitable for
study participation

- Subjects enrolled and dosed in phase 1b will be excluded from phase 2

Exclusion criteria for phase 1b and bevacizumab treatment (cohorts C, D and E) in phase 2

- Subjects with central nervous system tumor involvement

- Subjects with squamous NSCLC

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate (CR and PR) by modified RECIST

Outcome Time Frame:

Until disease progression, drug intolerability or withdrawal of consent

Safety Issue:


Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:



Belgium: Federal Public Service (FPS) Health, Food Chain Safety and Environment

Study ID:




Start Date:

November 2007

Completion Date:

February 2012

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms