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.
Name: MM-121
Name: Docetaxel
Description: Disease status will be assessed according to RECIST v 1.1
Measure: Progression Free Survival Time: Time from randomization to progressionDescription: Time from randomization to death
Measure: Overall survival Time: Approximately 3 yearsDescription: Based on RECIST v1.1
Measure: Objective Response Rate Time: approximately 3 yearsDescription: Time from randomization to progression
Measure: Time to Progression Time: approximately 3 yearsDescription: Adverse events analysis
Measure: Rate of adverse events reported with the combination of MM-121 with docetaxel Time: approximately 3 yearsDescription: 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.
Measure: Pharmacokinetic (PK) parameters of MM-121 in combination with docetaxel and docetaxel when given in combination with MM-121. Time: approximately 3 yearsAllocation: Randomized
Single Group Assignment
There is one SNP
Serum levels of MM-121 will be measured at a central lab using an enzyme-linked immunosorbent assay.. Inclusion Criteria: - Patients with a diagnosis of cytologically or histologically documented adenocarcinoma of the lung with either metastatic disease (stage IV), Stage IIIB or Stage IIIC 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 Inclusion Criteria: - Patients with a diagnosis of cytologically or histologically documented adenocarcinoma of the lung with either metastatic disease (stage IV), Stage IIIB or Stage IIIC 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 Non-Small Cell Lung Cancer NSCLC Adenocarcinoma Heregulin Lung Neoplasms Carcinoma, Non-Small-Cell Lung 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. --- L858R ---
Serum levels of MM-121 will be measured at a central lab using an enzyme-linked immunosorbent assay.. Inclusion Criteria: - Patients with a diagnosis of cytologically or histologically documented adenocarcinoma of the lung with either metastatic disease (stage IV), Stage IIIB or Stage IIIC 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 Inclusion Criteria: - Patients with a diagnosis of cytologically or histologically documented adenocarcinoma of the lung with either metastatic disease (stage IV), Stage IIIB or Stage IIIC 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 Non-Small Cell Lung Cancer NSCLC Adenocarcinoma Heregulin Lung Neoplasms Carcinoma, Non-Small-Cell Lung 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. --- L858R --- --- L858R ---