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A Phase 1b/2 Trial of AMG 386 in Combination With Pemetrexed and Carboplatin as First Line Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non Small Cell Lung Cancer

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Trial Information

A Phase 1b/2 Trial of AMG 386 in Combination With Pemetrexed and Carboplatin as First Line Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer


Inclusion Criteria:



- Histologically confirmed, unresectable stage IV non-squamous non small cell lung
cancer (NSCLC)

- Radiographically evaluable disease (measurable or non-measurable) per RECIST 1.1 with
modifications

- Adequate hematological, renal, and hepatic function, normal coagulation profile,
calculated CrCL ≥ 45 mL/min

- Other criteria may apply

Exclusion Criteria:

- Any prior chemotherapy or targeted therapy for non-squamous NSCLC

- Subjects with adenosquamous histology or any histology subtype containing greater
than 10% squamous cells

- Subjects with an epidermal growth factor receptor (EGFR) mutation sensitive to
treatment with a tyrosine kinase inhibitor (TKI)

- Subjects with known anaplastic lymphoma kinase (EML4-ALK) translocations

- History or presence of central nervous system metastases

- Central (chest) radiation therapy within 28 days prior to enrollment/randomization,
radiation therapy to any other site(s) within 14 days prior to
enrollment/randomization

- History of pulmonary hemorrhage or gross hemoptysis within 6 months

- History of arterial or venous thromboembolism within 12 months

- History of clinically significant bleeding within 6 months

- Clinically significant cardiovascular disease within 12 months

- Other criteria may apply

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Description:

Subjects will be evaluated for progression free survival.

Safety Issue:

Yes

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20101128

NCT ID:

NCT01666977

Start Date:

August 2012

Completion Date:

July 2019

Related Keywords:

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

Name

Location

Research SiteBentonville, Arkansas  
Research SiteAnaheim, California  
Research SiteAshland, Kentucky  
Research SiteBismarck, North Dakota  
Research SiteCharleston, South Carolina