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

• Status: Terminated
• Trial end date: 2019-01-02
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Elevation Oncology; Merrimack Pharmaceuticals
• Collaborator: Merrimack Pharmaceuticals
• Treatments: Docetaxel; Pemetrexed

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