SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02387216

Developed by Shray Alag, 2019.
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

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

Arm A: Experimental Arm

Name: Docetaxel

Description: approved chemotherapy treatment for NSCLC

Type: Drug

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:
Neoplasm of the lung
Genes 43
WT1 KRAS SLC22A18 STK11 IRF1 AKT1 C11ORF95 PRKN PPP2R1B ERBB2 TRPV3 TSC1 POU6F2 TSC2 EWSR1 RELA KEAP1 REST DIS3L2 SFTPA2 GPC3 MBTPS2 LMNA PTEN BRAF BRCA2 EGFR RB1 TRIP13 PDGFRB TERT SFTPC PIK3CA TRIM28 DICER1 MAP3K8 HPGD SLCO2A1 H19 TP53 NOTCH3 BAP1 WRN
Non-small cell lung carcinoma
Genes 2
TP53 BAP1