Lung Cancer Clinical Trial
A Study of MM-121 in Combination With Chemotherapy Versus Chemotherapy Alone in Heregulin Positive NSCLC
Summary
The purpose of this study is to determine whether the combination of MM-121 plus docetaxel is more effective than docetaxel alone in regards to PFS in patients with heregulin-positive NSCLC.
Full Description
This study is a randomized, open-label, international, multi-center, phase 2 study in patients with Heregulin-positive NSCLC histologically classified as adenocarcinoma that have progressed following no more than two systemic therapies for locally advanced or metastatic disease, one of which must have been a platinum containing regimen. All patients will initially be screened for heregulin status. Eligible patients will be randomized to receive MM-121 in combination with docetaxel versus docetaxel alone.
Eligibility Criteria
Inclusion Criteria:
Patients with a diagnosis of cytologically or histologically documented adenocarcinoma of the lung with either metastatic disease (stage IV), Stage IIIB or Stage IIIC disease not amenable to surgery with curative intent
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:
Known ALK mutation
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
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There are 35 Locations for this study
Tucson Arizona, 85715, United States
Los Angeles California, 90033, United States
Santa Rosa California, 95403, United States
Tampa Florida, 33612, United States
Chicago Illinois, 60611, United States
Lafayette Indiana, 47905, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Danvers Massachusetts, 01923, United States
Bronx New York, 10461, United States
New York New York, 10016, United States
Philadelphia Pennsylvania, 19111, United States
Pittsburgh Pennsylvania, 15224, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37232, United States
Fairfax Virginia, 22031, United States
Seattle Washington, 98101, United States
Toronto Ontario, M5G 2, Canada
Créteil Paris, 94010, France
Lyon cedex 08 Rhône-Alpes, 69317, France
Munchen Bayern, 80336, Germany
Bad Berka , 99437, Germany
Berlin , 13353, Germany
Frankfurt , 60488, Germany
Oldenburg , 26121, Germany
Budapest , H-112, Hungary
Miskolc , H-352, Hungary
Tatabanya , H-280, Hungary
Badalona Barcelona, 08916, Spain
Majadahonda Madrid, 28222, Spain
Barcelona , 08035, Spain
Madrid , 28007, Spain
Madrid , 28046, Spain
Malaga , 29010, Spain
Zaragoza , 50009, Spain
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