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

May 18, 2016 updated by: Amgen

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To evaluate the incidence of adverse events and clinical laboratory abnormalities defined as dose-limiting toxicity in subjects with metastatic non-squamous non-small cell lung cancer (NSCLC) treated with AMG 386 in combination with pemetrexed and carboplatin

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Research Site
      • Kogarah, New South Wales, Australia, 2217
        • Research Site
      • Randwick, New South Wales, Australia, 2031
        • Research Site
      • Tweed Heads, New South Wales, Australia, 2485
        • Research Site
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Research Site
    • Victoria
      • Bentleigh East, Victoria, Australia, 3165
        • Research Site
      • Heidelberg, Victoria, Australia, 3084
        • Research Site
  • Belgium
      • Bruxelles, Belgium, 1200
        • Research Site
  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Research Site
      • Oshawa, Ontario, Canada, L1G 2B9
        • Research Site
      • Ottawa, Ontario, Canada, K1H 8L6
        • Research Site
      • Toronto, Ontario, Canada, M4N 3M5
        • Research Site
    • Quebec
      • Laval, Quebec, Canada, H7M 3L9
        • Research Site
      • Levis, Quebec, Canada, G6V 3Z1
        • Research Site
      • Montreal, Quebec, Canada, H2L 4M1
        • Research Site
  • Greece
      • Heraklion, Greece, 71110
        • Research Site
      • Larissa, Greece, 41110
        • Research Site
      • Patra, Greece, 26500
        • Research Site
      • Thessaloniki, Greece, 56429
        • Research Site
  • Spain
      • Madrid, Spain, 28046
        • Research Site
    • Andalucía
      • Málaga, Andalucía, Spain, 29010
        • Research Site
    • Aragón
      • Zaragoza, Aragón, Spain, 50009
        • Research Site
  • United States
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Research Site
      • Hot Springs, Arkansas, United States, 71913
        • Research Site
    • California
      • Los Angeles, California, United States, 90048
        • Research Site
      • Palm Springs, California, United States, 92262
        • Research Site
      • Pleasant Hill, California, United States, 94523
        • Research Site
      • San Diego, California, United States, 92123
        • Research Site
      • Santa Monica, California, United States, 90403
        • Research Site
    • Illinois
      • Peoria, Illinois, United States, 61615
        • Research Site
    • Kentucky
      • Paducah, Kentucky, United States, 42003
        • Research Site
    • New Hampshire
      • Hannover, New Hampshire, United States, 03756
        • Research Site
    • New York
      • Bronx, New York, United States, 10461
        • Research Site
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Research Site
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Arm A: AMG 386 placebo IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles
Drug: AMG 386 Placebo
AMG 386 Placebo
Drug: Carboplatin
Carboplatin AUC 6
Drug: Pemetrexed
Pemetrexed 500 mg/m2
Experimental: Arm B
Arm B: AMG 386 15 mg/kg IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles
Drug: Carboplatin
Carboplatin AUC 6
Drug: Pemetrexed
Pemetrexed 500 mg/m2
Drug: AMG 386
15mg/kg
Drug: AMG 386
30 mg/kg
Experimental: Arm C
Arm C: AMG 386 30 mg/kg IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles
Drug: Carboplatin
Carboplatin AUC 6
Drug: Pemetrexed
Pemetrexed 500 mg/m2
Drug: AMG 386
15mg/kg
Drug: AMG 386
30 mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: Incidence of adverse events and clinical laboratory abnormalities defined as a DLT
Subjects will be evaluated for progression free survival.
Incidence of adverse events and clinical laboratory abnormalities defined as a DLT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

August 15, 2012

First Submitted That Met QC Criteria

August 15, 2012

First Posted (Estimate)

August 17, 2012

Study Record Updates

Last Update Posted (Estimate)

June 3, 2016

Last Update Submitted That Met QC Criteria

May 18, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20101128
  • 2011-001111-31 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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