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

This study has been completed.
Information provided by (Responsible Party):
Amgen Identifier:
First received: August 15, 2012
Last updated: November 23, 2015
Last verified: November 2015
The purpose of phase 2 of this this study is to estimate the treatment effect of study drug measuring progression free survival.

Condition Intervention Phase
Non Small Cell Lung Cancer
Drug: Arm A
Drug: Arm B
Drug: Arm C
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: Incidence of adverse events and clinical laboratory abnormalities defined as a DLT ] [ Designated as safety issue: Yes ]
    Subjects will be evaluated for progression free survival.

Enrollment: 36
Study Start Date: August 2012
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Arm A
Placebo + Pemetrexed + Carboplatin
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: Arm B
AMG 386 Dose 1 + Pemetrexed + Carboplatin
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: Arm C
AMG 386 dose 2 + Carboplatin + Pemetrexed

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

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01666977

  Show 35 Study Locations
Sponsors and Collaborators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen Identifier: NCT01666977     History of Changes
Other Study ID Numbers: 20101128  2011-001111-31 
Study First Received: August 15, 2012
Last Updated: November 23, 2015
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Growth Inhibitors
Growth Substances
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on May 05, 2016