A Study of MM-121 in Combination With Chemotherapy Versus Chemotherapy Alone in 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
California
Los Angeles
Florida
Tampa
Illinois
Chicago
Massachusetts
Boston
Danvers
New York
Bronx
New York
Pennsylvania
Philadelphia
Tennessee
Nashville
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