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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Cance

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Merrimack Pharmaceuticals

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

Original Primary Outcome: Progression-free survival [ Time Frame: Time from randomization to progression, approximately 2 years ]

Disease status will be assessed according to RECIST v 1.1


Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • 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 ]


Information By: Merrimack Pharmaceuticals

Dates:
Date Received: February 12, 2015
Date Started: February 2015
Date Completion: December 2018
Last Updated: August 4, 2016
Last Verified: August 2016