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

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Carboplatin; Pemetrexed; Trebananib

Criteria

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