A Study of MM-121 in Combination With Chemotherapy Versus Chemotherapy Alone in Heregulin Positive NSCLC
NCT ID: NCT02387216
Last Updated: 2021-10-12
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
153 participants
INTERVENTIONAL
2015-02-01
2019-01-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm A: Experimental Arm
MM-121 in combination with Docetaxel
MM-121
Investigational, fully human antibody targeting and inhibiting ErbB3
Docetaxel
approved chemotherapy treatment for NSCLC
Arm B: Comparator Arm
Docetaxel alone
Docetaxel
approved chemotherapy treatment for NSCLC
Interventions
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MM-121
Investigational, fully human antibody targeting and inhibiting ErbB3
Docetaxel
approved chemotherapy treatment for NSCLC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Not received more than 2 prior systemic therapies- one of which must have been a platinum based regimen- for primary or recurrent disease
* Tissue submitted for HRG-biomarker testing
* ECOG performance status (PS) of 0 or 1
Exclusion Criteria
* Presence of exon 19 deletion or exon 21 (L858R) substitution of the EGFR gene
* Received \>2 prior systemic anti-cancer drug regimen for locally advanced disease
* Prior treatment with an anti-ErbB3 antibody
* CTCAE grade 3 or higher peripheral neuropathy
* Symptomatic CNS metastases or CNS metastases requiring steroids
* Any other active malignancy requiring systemic therapy
* Clinically significant cardiac disease
18 Years
ALL
No
Sponsors
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Merrimack Pharmaceuticals
INDUSTRY
Elevation Oncology
INDUSTRY
Responsible Party
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Principal Investigators
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MM-121 Program Medical Director, MD
Role: STUDY_DIRECTOR
Merrimack Pharmaceuticals
Locations
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Tucson, Arizona, United States
Los Angeles, California, United States
Santa Rosa, California, United States
Tampa, Florida, United States
Chicago, Illinois, United States
Lafayette, Indiana, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Danvers, Massachusetts, United States
New York, New York, United States
The Bronx, New York, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Fairfax, Virginia, United States
Seattle, Washington, United States
Toronto, Ontario, Canada
Centre Léon Bérard
Lyon, Auvergne-Rhône-Alpes, France
CHI Creteil
Créteil, Paris, France
München, Bavaria, Germany
Bad Berka, , Germany
Berlin, , Germany
Frankfurt, , Germany
Oldenburg, , Germany
Budapest, , Hungary
Miskolc, , Hungary
Tatabánya, , Hungary
Badalona, Barcelona, Spain
Majadahonda, Madrid, Spain
Barcelona, , Spain
Madrid, , Spain
Madrid, , Spain
Málaga, , Spain
Zaragoza, , Spain
Countries
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References
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Sequist LV, Gray JE, Harb WA, Lopez-Chavez A, Doebele RC, Modiano MR, Jackman DM, Baggstrom MQ, Atmaca A, Felip E, Provencio M, Cobo M, Adiwijaya B, Kuesters G, Kamoun WS, Andreas K, Pipas JM, Santillana S, Cho BC, Park K, Shepherd FA. Randomized Phase II Trial of Seribantumab in Combination with Erlotinib in Patients with EGFR Wild-Type Non-Small Cell Lung Cancer. Oncologist. 2019 Aug;24(8):1095-1102. doi: 10.1634/theoncologist.2018-0695. Epub 2019 Apr 11.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MM-121-01-02-09
Identifier Type: -
Identifier Source: org_study_id
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