Phase 1b/2 Trial of AMG386 With Pemetrexed and Carboplatin in Non-Small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT01666977 |
Recruitment Status :
Completed
First Posted : August 17, 2012
Last Update Posted : June 3, 2016
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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 |
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 |

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
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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
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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
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Drug: AMG 386
30 mg/kg Drug: Pemetrexed Pemetrexed 500 mg/m2 Drug: Carboplatin Carboplatin AUC 6 |
- 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.

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Ages Eligible for Study: | 18 Years to 95 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
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

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
United States, Arkansas | |
Research Site | |
Fayetteville, Arkansas, United States, 72703 | |
Research Site | |
Hot Springs, Arkansas, United States, 71913 | |
United States, California | |
Research Site | |
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 | |
United States, Illinois | |
Research Site | |
Peoria, Illinois, United States, 61615 | |
United States, Kentucky | |
Research Site | |
Paducah, Kentucky, United States, 42003 | |
United States, New Hampshire | |
Research Site | |
Hannover, New Hampshire, United States, 03756 | |
United States, New York | |
Research Site | |
Bronx, New York, United States, 10461 | |
United States, North Dakota | |
Research Site | |
Bismarck, North Dakota, United States, 58501 | |
United States, South Carolina | |
Research Site | |
Greenville, South Carolina, United States, 29605 | |
Australia, New South Wales | |
Research Site | |
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 | |
Australia, Queensland | |
Research Site | |
Herston, Queensland, Australia, 4029 | |
Australia, Victoria | |
Research Site | |
Bentleigh East, Victoria, Australia, 3165 | |
Research Site | |
Heidelberg, Victoria, Australia, 3084 | |
Belgium | |
Research Site | |
Bruxelles, Belgium, 1200 | |
Canada, Ontario | |
Research Site | |
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 | |
Canada, Quebec | |
Research Site | |
Laval, Quebec, Canada, H7M 3L9 | |
Research Site | |
Levis, Quebec, Canada, G6V 3Z1 | |
Research Site | |
Montreal, Quebec, Canada, H2L 4M1 | |
Greece | |
Research Site | |
Heraklion, Greece, 71110 | |
Research Site | |
Larissa, Greece, 41110 | |
Research Site | |
Patra, Greece, 26500 | |
Research Site | |
Thessaloniki, Greece, 56429 | |
Spain | |
Research Site | |
Málaga, Andalucía, Spain, 29010 | |
Research Site | |
Zaragoza, Aragón, Spain, 50009 | |
Research Site | |
Madrid, Spain, 28046 |
Study Director: | MD | Amgen |
Responsible Party: | Amgen |
ClinicalTrials.gov Identifier: | NCT01666977 |
Other Study ID Numbers: |
20101128 2011-001111-31 ( EudraCT Number ) |
First Posted: | August 17, 2012 Key Record Dates |
Last Update Posted: | June 3, 2016 |
Last Verified: | May 2016 |
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 Carboplatin Pemetrexed |
Trebananib 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 |