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

Status: Active

Description

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.

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

Locations & Contacts

Arizona

Phoenix
University of Arizona Cancer Center at Saint Joseph's
Status: Active
Contact: Ann De Jong
Phone: 602-827-2684
Email: annd@email.arizona.edu

Florida

Tampa
Moffitt Cancer Center
Status: Active
Contact: Angela Akar
Phone: 813-745-4625
Email: angela.akar@moffitt.org

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: Active
Contact: David Boucher
Phone: 617-632-7889
Email: dhbouche@bidmc.harvard.edu
Dana-Farber Cancer Institute
Status: Active
Contact: Pasi Antero Janne
Phone: 866-790-4500
Email: pasi_janne@dfci.harvard.edu
Massachusetts General Hospital Cancer Center
Status: Active
Contact: Lecia Van Dam Sequist
Phone: 617-726-7812
Email: lvsequist@partners.org
Danvers
Mass General / North Shore Cancer Center
Status: Active
Name Not Available

Trial Objectives and Outline

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 & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Merrimack Pharmaceuticals

Trial IDs

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