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A Study of MM-121 in Combination With Chemotherapy Versus Chemotherapy Alone in Heregulin Positive NSCLC

Trial Status: Complete

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.

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

Arizona

Phoenix
Arizona Cancer Center-Phoenix Campus
Status: COMPLETED
Cancer Center at Saint Joseph's
Status: ACTIVE
Contact: Ann De Jong
Phone: 602-827-2684

California

Los Angeles
USC / Norris Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL

Florida

Tampa
Moffitt Cancer Center
Status: COMPLETED
Contact: Angela Akar
Phone: 813-745-4625

Illinois

Chicago
Northwestern University
Status: CLOSED_TO_ACCRUAL
University of Chicago Comprehensive Cancer Center
Status: COMPLETED
Contact: Adrian Javier Segura
Phone: 312-695-1354

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: ACTIVE
Contact: David Boucher
Phone: 617-632-7889
Brigham and Women's Hospital
Status: CLOSED_TO_ACCRUAL
Dana-Farber Cancer Institute
Status: ACTIVE
Contact: Pasi Antero Janne
Phone: 866-790-4500
Massachusetts General Hospital Cancer Center
Status: ACTIVE
Contact: Lecia Van Dam Sequist
Phone: 617-726-7812
Danvers
Mass General / North Shore Cancer Center
Status: ACTIVE

New York

Bronx
Montefiore Medical Center-Weiler Hospital
Status: COMPLETED
Contact: Haiying Cheng
Phone: 718-405-8539
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: COMPLETED

Pennsylvania

Philadelphia
Fox Chase Cancer Center
Status: ADMINISTRATIVELY_COMPLETE

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: CLOSED_TO_ACCRUAL

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.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
14ner Oncology Inc

  • Primary ID MM-121-01-02-09
  • Secondary IDs NCI-2015-00560, s15-00082
  • Clinicaltrials.gov ID NCT02387216