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

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ClinicalTrials.gov Identifier: NCT02387216
Recruitment Status : Recruiting
First Posted : March 12, 2015
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Merrimack Pharmaceuticals

February 12, 2015
March 12, 2015
May 1, 2018
February 2015
December 2018   (Final data collection date for primary outcome measure)
Progression Free Survival [ Time Frame: Time from randomization to progression ]
Disease status will be assessed according to RECIST v 1.1
Progression-free survival [ Time Frame: Time from randomization to progression, approximately 2 years ]
Disease status will be assessed according to RECIST v 1.1
Complete list of historical versions of study NCT02387216 on ClinicalTrials.gov Archive Site
  • Overall survival [ Time Frame: Approximately 3 years ]
    Time from randomization to death
  • Objective Response Rate [ Time Frame: approximately 3 years ]
    Based on RECIST v1.1
  • Time to Progression [ Time Frame: approximately 3 years ]
    Time from randomization to progression
  • Rate of adverse events reported with the combination of MM-121 with docetaxel [ Time Frame: approximately 3 years ]
    Adverse events analysis
  • Pharmacokinetic (PK) parameters of MM-121 in combination with docetaxel and docetaxel when given in combination with MM-121. [ Time Frame: approximately 3 years ]
    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.
  • Overall Survival [ Time Frame: Time from randomization to death, approximately 2 years ]
  • Objective Response Rate [ Time Frame: Approximately 2 years ]
  • Rate of adverse events reported with the combination of MM-121 with docetaxel or pemetrexed [ Time Frame: Approximately 2 years ]
  • Pharmacokinetic (PK) parameters of MM-121 in combination with docetaxel or pemetrexed, specifically focusing on "Area under the plasma concentration versus time curve (AUC)". [ Time Frame: Approximately 2 years ]
Not Provided
Not Provided
 
A Study of MM-121 in Combination With Chemotherapy Versus Chemotherapy Alone in Heregulin Positive NSCLC
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
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Non-Small Cell Lung Cancer
  • NSCLC
  • Adenocarcinoma
  • Heregulin
  • Drug: MM-121
    Investigational, fully human antibody targeting and inhibiting ErbB3
  • Drug: Docetaxel
    approved chemotherapy treatment for NSCLC
    Other Name: Taxotere
  • Experimental: Arm A: Experimental Arm
    MM-121 in combination with Docetaxel
    Interventions:
    • Drug: MM-121
    • Drug: Docetaxel
  • Active Comparator: Arm B: Comparator Arm
    Docetaxel alone
    Intervention: Drug: Docetaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
120
December 2018
December 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Canada,   France,   Germany,   Hungary,   Spain,   United States
 
 
NCT02387216
MM-121-01-02-09
Yes
Not Provided
Not Provided
Merrimack Pharmaceuticals
Merrimack Pharmaceuticals
Not Provided
Study Director: MM-121 Program Medical Director, MD Merrimack Pharmaceuticals
Merrimack Pharmaceuticals
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP