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

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Non Small Cell Lung Cancer	Drug: AMG 386; Drug: AMG 386 Placebo; Drug: Pemetrexed; Drug: Carboplatin	Phase 1; Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	36 participants
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
Study Start Date :	August 2012
Actual Primary Completion Date :	November 2015
Actual Study Completion Date :	November 2015

Arms and Interventions

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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: 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

Outcome Measures

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Primary Outcome Measures :

1. 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.

Eligibility Criteria

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 35 Study Locations

Sponsors and Collaborators

Amgen

Investigators

Study Director:	MD	Amgen

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

AmgenTrials clinical trials website 

Responsible Party:	Amgen
ClinicalTrials.gov Identifier:	NCT01666977 History of Changes
Other Study ID Numbers:	20101128; 2011-001111-31 ( EudraCT Number )
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