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
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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
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.
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.