Description:
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.
Title
- Brief Title: A Study of MM-121 in Combination With Chemotherapy Versus Chemotherapy Alone in Heregulin Positive NSCLC
- Official Title: SHERLOC: A Phase 2 Study of MM-121 in Combination With Docetaxel Versus Docetaxel Alone in Patients With Heregulin Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Merrimack Pharmaceuticals Inc.)
Clinical Trial IDs
- ORG STUDY ID:
MM-121-01-02-09
- NCT ID:
NCT02387216
Conditions
- Non-Small Cell Lung Cancer
- NSCLC
- Adenocarcinoma
- Heregulin
Interventions
Drug | Synonyms | Arms |
---|
MM-121 | seribantumab | Arm A: Experimental Arm |
Docetaxel | Taxotere | Arm A: Experimental Arm |
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.
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Arm A: Experimental Arm | Experimental | MM-121 in combination with Docetaxel | |
Arm B: Comparator Arm | Active Comparator | Docetaxel alone | |
Eligibility 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression Free Survival |
Time Frame: | Time from randomization to progression |
Safety Issue: | |
Description: | Disease status will be assessed according to RECIST v 1.1 |
Secondary Outcome Measures
Measure: | Overall survival |
Time Frame: | Approximately 3 years |
Safety Issue: | |
Description: | Time from randomization to death |
Measure: | Objective Response Rate |
Time Frame: | approximately 3 years |
Safety Issue: | |
Description: | Based on RECIST v1.1 |
Measure: | Time to Progression |
Time Frame: | approximately 3 years |
Safety Issue: | |
Description: | Time from randomization to progression |
Measure: | Rate of adverse events reported with the combination of MM-121 with docetaxel |
Time Frame: | approximately 3 years |
Safety Issue: | |
Description: | Adverse events analysis |
Measure: | Pharmacokinetic (PK) parameters of MM-121 in combination with docetaxel and docetaxel when given in combination with MM-121. |
Time Frame: | approximately 3 years |
Safety Issue: | |
Description: | Pharmacokinetic (PK) profile of MM-121 when given in combination with docetaxel, and of docetaxel when given in combination with MM-121. PK evaluation will be performed on samples obtained at Week 1 pre-dose and post-dose and at pre-dose at Cycle 2 and beyond to assess pre-treatment trough concentrations of MM-121. The maximum observed concentration (Cmax) will be presented and calculated using non-compartmental analysis. Serum levels of MM-121 will be measured at a central lab using an enzyme-linked immunosorbent assay. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Elevation Oncology |
Trial Keywords
- NSCLC
- Non-Small Cell Lung Cancer
- heregulin
- ErbB3
- docetaxel
Last Updated
November 7, 2019