Phase 1b/2 Trial of AMG386 With Pemetrexed and Carboplatin in Non-Small Cell Lung Cancer
A Phase 1b/2 Trial of AMG 386 in Combination With Pemetrexed and Carboplatin as First Line Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer
2 other identifiers
interventional
36
6 countries
35
Brief Summary
The purpose of this phase 1b/2 study is to estimate the treatment effect of study drug measuring progression free survival.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2012
Typical duration for phase_1
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 15, 2012
CompletedFirst Posted
Study publicly available on registry
August 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedJune 3, 2016
May 1, 2016
3.3 years
August 15, 2012
May 18, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free Survival
Subjects will be evaluated for progression free survival.
Incidence of adverse events and clinical laboratory abnormalities defined as a DLT
Study Arms (3)
Arm A
EXPERIMENTALArm A: AMG 386 placebo IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles
Arm B
EXPERIMENTALArm B: AMG 386 15 mg/kg IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles
Arm C
EXPERIMENTALArm C: AMG 386 30 mg/kg IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (35)
Research Site
Fayetteville, Arkansas, 72703, United States
Research Site
Hot Springs, Arkansas, 71913, United States
Research Site
Los Angeles, California, 90048, United States
Research Site
Palm Springs, California, 92262, United States
Research Site
Pleasant Hill, California, 94523, United States
Research Site
San Diego, California, 92123, United States
Research Site
Santa Monica, California, 90403, United States
Research Site
Peoria, Illinois, 61615, United States
Research Site
Paducah, Kentucky, 42003, United States
Research Site
Hannover, New Hampshire, 03756, United States
Research Site
The Bronx, New York, 10461, United States
Research Site
Bismarck, North Dakota, 58501, United States
Research Site
Greenville, South Carolina, 29605, United States
Research Site
Camperdown, New South Wales, 2050, Australia
Research Site
Kogarah, New South Wales, 2217, Australia
Research Site
Randwick, New South Wales, 2031, Australia
Research Site
Tweed Heads, New South Wales, 2485, Australia
Research Site
Herston, Queensland, 4029, Australia
Research Site
Bentleigh East, Victoria, 3165, Australia
Research Site
Heidelberg, Victoria, 3084, Australia
Research Site
Brussels, 1200, Belgium
Research Site
Hamilton, Ontario, L8V 5C2, Canada
Research Site
Oshawa, Ontario, L1G 2B9, Canada
Research Site
Ottawa, Ontario, K1H 8L6, Canada
Research Site
Toronto, Ontario, M4N 3M5, Canada
Research Site
Laval, Quebec, H7M 3L9, Canada
Research Site
Lévis, Quebec, G6V 3Z1, Canada
Research Site
Montreal, Quebec, H2L 4M1, Canada
Research Site
Heraklion, 71110, Greece
Research Site
Larissa, 41110, Greece
Research Site
Pátrai, 26500, Greece
Research Site
Thessaloniki, 56429, Greece
Research Site
Málaga, Andalusia, 29010, Spain
Research Site
Zaragoza, Aragon, 50009, Spain
Research Site
Madrid, Madrid, 28046, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2012
First Posted
August 17, 2012
Study Start
August 1, 2012
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
June 3, 2016
Record last verified: 2016-05