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

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.

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