Clinical trial NCT02387216: A Study of MM-121 in Combination With Chemotherapy Versus Chemotherapy Alone in Heregulin Positive NSCLC
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.)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
NSCLC
Adenocarcinoma
Heregulin
Keywords: NSCLC
Non-Small Cell Lung Cancer
heregulin
ErbB3
docetaxel
Lead sponsor: Elevation Oncology
Sponsor class: INDUSTRY
Collaborators: name: Merrimack Pharmaceuticals
First posted: 2015-03-12
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Randomized, open-label, international, multi-center, Phase 2 study in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Progression Free Survival
timeFrame: Randomization until progression of disease or death due to any cause within 3 years,11 months (the study terminated prematurely)
Secondary outcomes:
measure: Overall Survival
timeFrame: From date of randomization until the date of death from any cause assessed upto 3 years,11 months (the study terminated prematurely)
measure: Objective Response Rate
timeFrame: Randomization through end of study up to 3 years, 11 months (the study terminated prematurely)
measure: Time to Progression
timeFrame: Randomization to date of objective tumor progression up to 3 years, 11 months (the study terminated prematurely)
measure: Number of Participants With Treatment-emergent Adverse Events Reported With the Combination of MM-121 With Docetaxel Versus Docetaxel Alone
timeFrame: TEAEs were collected through the study completion (02 Jan 2019), up to 3 years, 11 months
measure: Pharmacokinetic (PK) Parameters of MM-121 in Combination With Docetaxel and Docetaxel When Given in Combination With MM-121.
timeFrame: 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
measure: Percentage of Participants With Treatment-emergent Adverse Events Reported With the Combination of MM-121 With Docetaxel Versus Docetaxel Alone
timeFrame: TEAEs were collected through the study completion (02 Jan 2019), up to 3 years, 11 months
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: Santa Rosa
country: United States
state: California
city: Tampa
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Lafayette
country: United States
state: Indiana
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Danvers
country: United States
state: Massachusetts
city: Bronx
country: United States
state: New York
city: New York
country: United States
state: New York
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Fairfax
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Toronto
country: Canada
state: Ontario
city: Créteil
country: France
facility: CHI Creteil
state: Paris
city: Lyon cedex 08
country: France
facility: Centre Léon Bérard
state: Rhône-Alpes
city: Munchen
country: Germany
state: Bayern
city: Bad Berka
country: Germany
city: Berlin
country: Germany
city: Frankfurt
country: Germany
city: Oldenburg
country: Germany
city: Budapest
country: Hungary
city: Miskolc
country: Hungary
city: Tatabanya
country: Hungary
city: Badalona
country: Spain
state: Barcelona
city: Majadahonda
country: Spain
state: Madrid
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Zaragoza
country: Spain
Study officials:
affiliation: Merrimack Pharmaceuticals
name: MM-121 Program Medical Director, MD
role: STUDY_DIRECTOR
References:
citation: Sequist LV, Gray JE, Harb WA, Lopez-Chavez A, Doebele RC, Modiano MR, Jackman DM, Baggstrom MQ, Atmaca A, Felip E, Provencio M, Cobo M, Adiwijaya B, Kuesters G, Kamoun WS, Andreas K, Pipas JM, Santillana S, Cho BC, Park K, Shepherd FA. Randomized Phase II Trial of Seribantumab in Combination with Erlotinib in Patients with EGFR Wild-Type Non-Small Cell Lung Cancer. Oncologist. 2019 Aug;24(8):1095-1102. doi: 10.1634/theoncologist.2018-0695. Epub 2019 Apr 11.