SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT02387216

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

SHERLOC: A Phase 2 Study of MM-121 in Combination With Docetaxel Versus Docetaxel Alone in Patients With Heregulin Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Merrimack Pharmaceuticals Inc.)

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.

NCT02387216 Non-Small Cell Lung Cancer NSCLC Adenocarcinoma Heregulin
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung Adenocarcinoma
HPO:Neoplasm of the lung Non-small cell lung carcinoma

2 Interventions

Name: MM-121

Description: Investigational, fully human antibody targeting and inhibiting ErbB3
Type: Drug
Group Labels: 1

Arm A: Experimental Arm

Name: Docetaxel

Description: approved chemotherapy treatment for NSCLC
Type: Drug
Group Labels: 2

Arm A: Experimental Arm Arm B: Comparator Arm


Primary Outcomes

Description: Disease status will be assessed according to RECIST v 1.1

Measure: Progression Free Survival

Time: Time from randomization to progression

Secondary Outcomes

Description: Time from randomization to death

Measure: Overall survival

Time: Approximately 3 years

Description: Based on RECIST v1.1

Measure: Objective Response Rate

Time: approximately 3 years

Description: Time from randomization to progression

Measure: Time to Progression

Time: approximately 3 years

Description: Adverse events analysis

Measure: Rate of adverse events reported with the combination of MM-121 with docetaxel

Time: approximately 3 years

Description: 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 years

Purpose: Treatment

Allocation: Randomized

Single Group Assignment


There is one SNP

SNPs


1 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 Adenocarcinoma 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 Adenocarcinoma 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 ---



HPO Nodes


HPO: