Phase 1b/2 Trial of AMG386 With Pemetrexed and Carboplatin in Non-Small Cell Lung Cancer

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Non Small Cell Lung Cancer

In brief

The purpose of this phase 1b/2 study is to estimate the treatment effect of study drug measuring progression free survival.

Key facts

Study ID

NCT01666977

Run by

Amgen

People needed

36

Starts

2012-08-01

Expected to finish

2015-11-01

Last updated by the study team

2016-06-03

Who can join

Age: 18 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Fayetteville, Arkansas, United States
• Research Site — Hot Springs, Arkansas, United States
• Research Site — Los Angeles, California, United States
• Research Site — Palm Springs, California, United States
• Research Site — Pleasant Hill, California, United States
• Research Site — San Diego, California, United States
• Research Site — Santa Monica, California, United States
• Research Site — Peoria, Illinois, United States
• Research Site — Paducah, Kentucky, United States
• Research Site — Hannover, New Hampshire, United States
• Research Site — The Bronx, New York, United States
• Research Site — Bismarck, North Dakota, United States
• Research Site — Greenville, South Carolina, United States
• Research Site — Camperdown, New South Wales, Australia
• Research Site — Kogarah, New South Wales, Australia
• Research Site — Randwick, New South Wales, Australia
• Research Site — Tweed Heads, New South Wales, Australia
• Research Site — Herston, Queensland, Australia
• Research Site — Bentleigh East, Victoria, Australia
• Research Site — Heidelberg, Victoria, Australia
• Research Site — Brussels, Belgium
• Research Site — Hamilton, Ontario, Canada
• Research Site — Oshawa, Ontario, Canada
• Research Site — Ottawa, Ontario, Canada
• Research Site — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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