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CompletedPhase 1 / Phase 2NCT01666977
Official study title

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

Study summary

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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAMG 386 and AMG 386

Plus 3 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 3, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?35 U.S. locations

Locations may change over time.

Who runs it?Amgen

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Amgen
Interventions being studied
Drug: AMG 386; Drug: AMG 386; Drug: AMG 386 Placebo; Drug: Pemetrexed; Drug: Carboplatin
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Treatment approach
Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Research SiteFayetteville, Arkansas
  • Research SiteHot Springs, Arkansas
  • Research SiteLos Angeles, California
  • Research SitePalm Springs, California
  • Research SitePleasant Hill, California
  • Research SiteSan Diego, California
  • Research SiteSanta Monica, California
  • Research SitePeoria, Illinois
  • Research SitePaducah, Kentucky
  • Research SiteHannover, New Hampshire
  • Research SiteThe Bronx, New York
  • Research SiteBismarck, North Dakota

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 3, 2016. Always confirm current availability with the study team.

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