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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

Brief 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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer NSCLC Adenocarcinoma Heregulin Drug: MM-121 Drug: Docetaxel Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: Arm A: Experimental Arm
MM-121 in combination with Docetaxel
Drug: MM-121
Investigational, fully human antibody targeting and inhibiting ErbB3

Drug: Docetaxel
approved chemotherapy treatment for NSCLC
Other Name: Taxotere

Active Comparator: Arm B: Comparator Arm
Docetaxel alone
Drug: Docetaxel
approved chemotherapy treatment for NSCLC
Other Name: Taxotere




Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: Time from randomization to progression ]
    Disease status will be assessed according to RECIST v 1.1


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Approximately 3 years ]
    Time from randomization to death

  2. Objective Response Rate [ Time Frame: approximately 3 years ]
    Based on RECIST v1.1

  3. Time to Progression [ Time Frame: approximately 3 years ]
    Time from randomization to progression

  4. Rate of adverse events reported with the combination of MM-121 with docetaxel [ Time Frame: approximately 3 years ]
    Adverse events analysis

  5. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02387216


  Show 36 Study Locations
Sponsors and Collaborators
Merrimack Pharmaceuticals
Investigators
Study Director: MM-121 Program Medical Director, MD Merrimack Pharmaceuticals

Responsible Party: Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02387216     History of Changes
Other Study ID Numbers: MM-121-01-02-09
First Posted: March 12, 2015    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018

Keywords provided by Merrimack Pharmaceuticals:
NSCLC
Non-Small Cell Lung Cancer
heregulin
ErbB3
docetaxel

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action