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

Completed

• Conditions: lungcancer; Non Small Cell Lungcancer; 10029107

• Registration Number: NL-OMON31650
• Lead Sponsor: Amgen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 19

Inclusion Criteria

· Histologically or cytologically confirmed Non-Small Cell Lung Cancer
(NSCLC).
· Subjects must have advanced NSCLC stage IIIb or Stage IV disease.
. Planning to receive at least 6 cycles of therapy
· ECOG performance status of 0 or 1
· Life expectancy greater than 3 months
· ³18 years old
· INR £ 1.2 and PTT is no greater than ULN within 1 week prior to
enrollment

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 3 years
· Myocardial infarction, or unstable or uncontrolled disease or condition
related to or impacting cardiac function within 1
year of enrollment
· Uncontrolled hypertension
· History of arterial thrombosis, pulmonary embolus 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
. Prior chemotherapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>End point: Phase 1b:<br /><br><br /><br>Primary Endpoint:<br /><br>· Incidence of dose-limiting toxicities (DLTs)<br /><br>· Incidence and severity of adverse events<br /><br><br /><br>End point: Phase 2:<br /><br>Primary Endpoint:<br /><br>· Objective response rate (complete or partial response)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Phase II:<br /><br><br /><br>Secondary Efficacy Endpoints:<br /><br>· Overall survival<br /><br>· Progression free survival<br /><br>· Time to response<br /><br>· Duration of response<br /><br>· Time to progression</p><br>