Clinical Trial 18197

Cancer Type: Thoracic
Interventions:Alimta (Pemetrexed); MM-121; Not Applicable; Pemetrexed; Taxotere (docetaxel); docetaxel

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Jhanelle Gray

Overview

Study 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 main purpose of this study is to find out more about the side effects of MM-121 when combined with docetaxel or pemetrexed, and to learn if cancer cell growth (disease progression) is delayed in people taking MM-121 with docetaxel or pemetrexed. Researchers are also trying to learn about: - The level of MM-121 that remains in the human body at different time points when MM-121 is combined with docetaxel or pemetrexed - The relationship between the biomarker, heregulin, and cancer cell growth (disease progression) in people dosed only with docetaxel or pemetrexed. - Other biomarkers which are related to the biomarker for this study.

Objective

Primary - Interventional Group only: *To determine whether the combination of MM-121 plus docetaxel or pemetrexed is more effective than docetaxel or pemetrexed alone based on investigator assessed Progression Free Survival (PFS) according to RECIST 1.1 in HRG positive patients. Secondary - Interventional Group only: *To determine whether the combination of MM-121 plus docetaxel or pemetrexed is more effective than docetaxel or pemetrexed alone based on centrally assessed Progression Free Survival (PFS) according to RECIST 1.1 in HRG positive patients. *To determine whether the combination of MM-121 plus docetaxel or pemetrexed is more effective than docetaxel or pemetrexed alone based on Overall Survival (OS) in HRG positive patients. *To compare the efficacy of the combination of MM-121 plus docetaxel or pemetrexed to docetaxel or pemetrexed alone using local assessment: Objective response rate (ORR) based on RECIST 1.1; Duration of objective response. *To compare the efficacy of the combination of MM-121 plus docetaxel orpemetrexed to docetaxel or pemetrexed alone using central assessment: Objective response rate (ORR) based on RECIST 1.1; Duration of response. *To describe the safety profile of MM-121 in combination with docetaxel or pemetrexed. *To describe the pharmacokinetic (PK) parameters of MM-121.

Inclusion Criteria

  • A diagnosis of cytologically or histologically confirmed non-small cell lung cancer (NSCLC) with either metastatic disease (stage IV) or Stage IIIB disease not amenable to surgery with curative intent
  • Disease progression or evidence of recurrent disease during or after the last systemic therapy as documented by radiographic assessment
  • Received nivolumab, pembrolizumab, or other anti-PD-1 or anti-PD-L1 therapy
  • Tissue submitted for heregulin (HRG)-biomarker testing
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
  • Clinically eligible for intended chemotherapy, docetaxel or premetrexed, once every 3 weeks per the investigator¿s judgement
  • 18 years of age or older

  • Exclusion Criteria

  • Known anaplastic lymphoma kinase (ALK) mutation
  • For adenocarcinoma participants only: Presence of exon 19 deletion or exon 21 (L858R) substitution of the epidermal growth factor receptor (EGFR) gene
  • Pregnant or lactating
  • Received >3 prior systemic anti-cancer drug regimen for locally advanced and/or metastatic disease
  • Prior treatment with an anti-ErbB3 antibody
  • Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher peripheral neuropathy
  • Clinically active central nervous system (CNS) metastasis
  • Any other active malignancy requiring systemic therapy
  • Clinically significant cardiac disease