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

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

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.

Lead Organization
Merrimack Pharmaceuticals