Clinical Trials /

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

NCT02387216

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

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

Clinical Trial IDs

  • ORG STUDY ID: MM-121-01-02-09
  • NCT ID: NCT02387216

Conditions

  • Non-Small Cell Lung Cancer
  • NSCLC
  • Adenocarcinoma
  • Heregulin

Interventions

DrugSynonymsArms
MM-121Arm A: Experimental Arm
DocetaxelTaxotereArm 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

NameTypeDescriptionInterventions
Arm A: Experimental ArmExperimentalMM-121 in combination with Docetaxel
  • MM-121
  • Docetaxel
Arm B: Comparator ArmActive ComparatorDocetaxel alone
  • Docetaxel

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with a diagnosis of cytologically or histologically documented adenocarcinoma
             of the lung with either metastatic disease (stage IV) or Stage IIIB 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:Recruiting
Lead Sponsor:Merrimack Pharmaceuticals

Trial Keywords

  • NSCLC
  • Non-Small Cell Lung Cancer
  • heregulin
  • ErbB3
  • docetaxel

Last Updated

January 22, 2018