A Study of MM-121 in Combination With Chemotherapy Versus Chemotherapy Alone in Heregulin Positive NSCLC
Purpose
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.
Conditions
- Non-Small Cell Lung Cancer
- NSCLC
- Adenocarcinoma
- Heregulin
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Randomized, open-label, international, multi-center, Phase 2 study in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm A: Experimental Arm |
MM-121 in combination with Docetaxel |
|
|
Active Comparator Arm B: Comparator Arm |
Docetaxel alone |
|
More Details
- Status
- Terminated
- Sponsor
- Elevation Oncology
Study Contact
Detailed Description
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.