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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01666977

First Posted: August 17, 2012

Last Update Posted: June 3, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Amgen

Purpose

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

Condition	Intervention	Phase
Non Small Cell Lung Cancer	Drug: AMG 386 Drug: AMG 386 Placebo Drug: Pemetrexed Drug: Carboplatin	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, 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:

Genetics Home Reference related topics: lung cancer

MedlinePlus related topics: Lung Cancer

Drug Information available for: Carboplatin Pemetrexed Pemetrexed disodium

U.S. FDA Resources

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 ]
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: AMG 386 Placebo AMG 386 Placebo Drug: Pemetrexed Pemetrexed 500 mg/m2 Drug: Carboplatin Carboplatin AUC 6
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: AMG 386 15mg/kg Drug: Pemetrexed Pemetrexed 500 mg/m2 Drug: Carboplatin Carboplatin AUC 6
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: AMG 386 30 mg/kg Drug: Pemetrexed Pemetrexed 500 mg/m2 Drug: Carboplatin Carboplatin AUC 6

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

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 95 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01666977

Show 35 Study Locations

Sponsors and Collaborators

Amgen

Investigators


Study Director:	MD	Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site


Responsible Party:	Amgen
ClinicalTrials.gov Identifier:	NCT01666977 History of Changes
Other Study ID Numbers:	20101128 2011-001111-31 ( EudraCT Number )
First Submitted:	August 15, 2012
First Posted:	August 17, 2012
Last Update Posted:	June 3, 2016
Last Verified:	May 2016

Additional relevant MeSH terms:


Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Trebananib Carboplatin	Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors

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