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

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

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.

Trial Description

Primary Outcome:

  • Overall Survival
Secondary Outcome:
  • Progression-free survival
  • Independent Central Review - PFS
  • Objective Response Rate
  • Time to Progression
  • Rate of adverse events reported with the combination of MM-121 with docetaxel or pemetrexed
  • Assess health-related quality of life (HRQOL) in NSCLC
  • Pharmacokinetic (PK) parameters of MM-121 in combination with docetaxel or pemetrexed and of docetaxel and pemetrexed when given in combination with MM-121.
This study is a randomized, open-label, international, multi-centre, 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.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society