CompletedPhase 1 / Phase 2NCT01666977

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

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

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

StatusCompleted
PhasePhase 1 / Phase 2
U.S. locations35
SponsorAmgen
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.

03
Public criteria

Who may be able to participate

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

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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