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Trial record 1 of 1 for:    nct 02387216
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A Study of MM-121 in Combination With Chemotherapy Versus Chemotherapy Alone in Heregulin Positive NSCLC

This study is currently recruiting participants.
Verified August 2016 by Merrimack Pharmaceuticals
Sponsor:
ClinicalTrials.gov Identifier:
NCT02387216
First Posted: March 12, 2015
Last Update Posted: August 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
  Purpose
The purpose of this study is to determine whether the combination of MM-121 plus docetaxel or pemetrexed is more effective than docetaxel or pemetrexed alone in regards to OS in patients with heregulin-positive NSCLC.

Condition Intervention Phase
Non-Small Cell Lung Cancer NSCLC Adenocarcinoma Squamous Cell Carcinoma Heregulin Large Cell Carcinoma Drug: MM-121 Drug: Docetaxel Drug: Pemetrexed Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of MM-121 in Combination With Docetaxel or Pemetrexed Versus Docetaxel or Pemetrexed Alone in Patients With Heregulin Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Merrimack Pharmaceuticals:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: Time from randomization to death, approximately 3 years ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Time from randomization to progression, approximately 3 years ]
    Disease status will be assessed according to RECIST v 1.1

  • Independent Central Review - PFS [ Time Frame: Approximately 3 years ]
  • Objective Response Rate [ Time Frame: Approximately 3 years ]
    Based on RECIST v1.1

  • Time to Progression [ Time Frame: Approximately 3 years ]
  • Rate of adverse events reported with the combination of MM-121 with docetaxel or pemetrexed [ Time Frame: Approximately 3 years ]
  • Assess health-related quality of life (HRQOL) in NSCLC [ Time Frame: Approximately 3 years ]
  • Pharmacokinetic (PK) parameters of MM-121 in combination with docetaxel or pemetrexed and of docetaxel and pemetrexed when given in combination with MM-121. [ Time Frame: Approximately 3 years ]

Estimated Enrollment: 280
Study Start Date: February 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: Experimental Arm
MM-121 in combination with either Docetaxel or Pemetrexed (Investigator's choice)
Drug: MM-121
Investigational, fully human antibody targeting and inhibiting ErbB3
Drug: Docetaxel
approved chemotherapy treatment for NSCLC
Other Name: Taxotere
Drug: Pemetrexed
approved chemotherapy treatment for NSCLC
Other Name: ALIMTA
Active Comparator: Arm B: Comparator Arm
Docetaxel or Pemetrexed (Investigator's choice) alone
Drug: Docetaxel
approved chemotherapy treatment for NSCLC
Other Name: Taxotere
Drug: Pemetrexed
approved chemotherapy treatment for NSCLC
Other Name: ALIMTA

Detailed Description:
This study is a randomized, open-label, international, multi-center, phase 2 study in patients with Heregulin-positive NSCLC that have progressed following no more than three systemic therapies for locally advanced or metastatic disease, of which one must have been an anti-PD-1 or anti-PD-L1 therapy. All patients will initially be screened for heregulin status. Eligible patients will be randomized to receive MM-121 in combination with investigator's choice of either docetaxel or pemetrexed versus docetaxel or pemetrexed alone.
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients with a diagnosis of cytologically or histologically confirmed NSCLC with either metastatic disease (stage IV) or Stage IIIB disease not amenable to surgery with curative intent
  • Failed an anti-PD-1 or anti-PD-L1 therapy and has not received more than 3 prior systemic therapies 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 >3 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
  Contacts and Locations
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 34 Study Locations
Sponsors and Collaborators
Merrimack Pharmaceuticals
Investigators
Study Director: MM-121 Program Medical Director, MD Merrimack Pharmaceuticals
  More Information

Responsible Party: Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02387216     History of Changes
Other Study ID Numbers: MM-121-01-02-09
First Submitted: February 12, 2015
First Posted: March 12, 2015
Last Update Posted: August 8, 2016
Last Verified: August 2016

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

Additional relevant MeSH terms:
Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous Cell
Adenocarcinoma
Carcinoma, Large Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplasms, Squamous Cell
Docetaxel
Pemetrexed
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors