Brief Summary
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.
Brief Title
A Study of MM-121 in Combination With Chemotherapy Versus Chemotherapy Alone in Heregulin Positive NSCLC
Detailed Description
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. All patients will initially be screened for heregulin status. Eligible patients will be randomized to receive MM-121 in combination with docetaxel versus docetaxel alone.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Non-Small Cell Lung Cancer
NSCLC
Adenocarcinoma
Heregulin
Eligibility Criteria
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
* 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
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
* 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
Gender
All
Gender Based
false
Keywords
NSCLC
Non-Small Cell Lung Cancer
heregulin
ErbB3
docetaxel
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02387216
Org Class
Industry
Org Full Name
Elevation Oncology
Org Study Id
MM-121-01-02-09
Overall Status
Terminated
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
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.)
Primary Outcomes
Outcome Description
Progression Free Survival is defined as the time from randomization to the first documented radiographical progression of disease using RECIST v.1.1, or death from any cause, whichever came first based on investigator assessment.
Patients that do not experience progression or death at the time of analysis were to be progression censored at the date of last valid tumor assessment. Progression-free survival time distribution and median survival for each treatment group were analyzed using the Kaplan-Meier method. Tumor response was evaluated by the local radiologist according to RECIST version 1.1 to establish disease progression by CT or MRI.
Patients that do not experience progression or death at the time of analysis were to be progression censored at the date of last valid tumor assessment. Progression-free survival time distribution and median survival for each treatment group were analyzed using the Kaplan-Meier method. Tumor response was evaluated by the local radiologist according to RECIST version 1.1 to establish disease progression by CT or MRI.
Outcome Measure
Progression Free Survival
Outcome Time Frame
Randomization until progression of disease or death due to any cause within 3 years,11 months (the study terminated prematurely)
Secondary Outcomes
Outcome Description
Overall Survival (OS) is defined as the time from the date of randomization to the date of death from any cause
Outcome Time Frame
From date of randomization until the date of death from any cause assessed upto 3 years,11 months (the study terminated prematurely)
Outcome Measure
Overall Survival
Outcome Description
Objective Response Rate (ORR) is defined as the proportion of patients a best overall response characterised as either a Complete Response (CR) or Partial Response (PR), as defined according to RECIST v1.1 guidelines, relative to the total number of evaluable patients.
Complete Response (CR) is defined as disappearance of all lesions and pathologic lymph nodes.
Partial Response (PR) is defined as \>=30% decrease in the sum of the longest diameter of target lesions
Complete Response (CR) is defined as disappearance of all lesions and pathologic lymph nodes.
Partial Response (PR) is defined as \>=30% decrease in the sum of the longest diameter of target lesions
Outcome Time Frame
Randomization through end of study up to 3 years, 11 months (the study terminated prematurely)
Outcome Measure
Objective Response Rate
Outcome Description
Time to Progression (TTP) is defined as the time from the date of randomization to the date of objective tumor progression. In the actual analysis, duration of response (DOR) was analysed.
Outcome Time Frame
Randomization to date of objective tumor progression up to 3 years, 11 months (the study terminated prematurely)
Outcome Measure
Time to Progression
Outcome Description
Treatment-emergent adverse events (TEAEs) are defined as any event that occurred after the first dose of study drug and was not present prior to study drug administration or worsened in severity after study drug administration
Outcome Time Frame
TEAEs were collected through the study completion (02 Jan 2019), up to 3 years, 11 months
Outcome Measure
Number of Participants With Treatment-emergent Adverse Events Reported With the Combination of MM-121 With Docetaxel Versus Docetaxel Alone
Outcome Description
Pharmacokinetic (PK) profile of MM-121 when given in combination with docetaxel, and of docetaxel when given in combination with MM-121. The maximum observed concentration (Cmax) were to be presented and calculated using non-compartmental analysis. Serum levels of MM-121 were to be measured at a central lab using an enzyme-linked immunosorbent assay.
Outcome Time Frame
The study terminated prematurely after 3 years, 11 months (02 Jan 2019). PK evaluation were to 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 through concentrations of MM-121
Outcome Measure
Pharmacokinetic (PK) Parameters of MM-121 in Combination With Docetaxel and Docetaxel When Given in Combination With MM-121.
Outcome Description
Treatment-emergent adverse events (TEAEs) are defined as any event that occurred after the first dose of study drug and was not present prior to study drug administration or worsened in severity after study drug administration
Outcome Time Frame
TEAEs were collected through the study completion (02 Jan 2019), up to 3 years, 11 months
Outcome Measure
Percentage of Participants With Treatment-emergent Adverse Events Reported With the Combination of MM-121 With Docetaxel Versus Docetaxel Alone
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Haiying Cheng
Investigator Email
HCHENG@montefiore.org
Investigator Phone
718-405-8404