Study Stopped
Based on the preliminary results seen during interim analysis, which were confirmed in the final analysis, the Sponsor terminated the study
A Study of MM-121 in Combination With Chemotherapy Versus Chemotherapy Alone in Heregulin Positive NSCLC
SHERLOC
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.)
1 other identifier
interventional
153
6 countries
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 nonsmall-cell-lung-cancer
Started Feb 2015
Typical duration for phase_2 nonsmall-cell-lung-cancer
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 12, 2015
CompletedFirst Posted
Study publicly available on registry
March 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 2, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 2, 2019
CompletedResults Posted
Study results publicly available
October 12, 2021
CompletedOctober 12, 2021
October 1, 2021
3.9 years
February 12, 2015
September 22, 2020
October 11, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival
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.
Randomization until progression of disease or death due to any cause within 3 years,11 months (the study terminated prematurely)
Secondary Outcomes (6)
Overall Survival
From date of randomization until the date of death from any cause assessed upto 3 years,11 months (the study terminated prematurely)
Objective Response Rate
Randomization through end of study up to 3 years, 11 months (the study terminated prematurely)
Time to Progression
Randomization to date of objective tumor progression up to 3 years, 11 months (the study terminated prematurely)
Number of Participants With Treatment-emergent Adverse Events Reported With the Combination of MM-121 With Docetaxel Versus Docetaxel Alone
TEAEs were collected through the study completion (02 Jan 2019), up to 3 years, 11 months
Pharmacokinetic (PK) Parameters of MM-121 in Combination With Docetaxel and Docetaxel When Given in Combination With MM-121.
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
- +1 more secondary outcomes
Study Arms (2)
Arm A: Experimental Arm
EXPERIMENTALMM-121 in combination with Docetaxel
Arm B: Comparator Arm
ACTIVE COMPARATORDocetaxel alone
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Elevation Oncologylead
- Merrimack Pharmaceuticalscollaborator
Study Sites (35)
Unknown Facility
Tucson, Arizona, 85715, United States
Unknown Facility
Los Angeles, California, 90033, United States
Unknown Facility
Santa Rosa, California, 95403, United States
Unknown Facility
Tampa, Florida, 33612, United States
Unknown Facility
Chicago, Illinois, 60611, United States
Unknown Facility
Lafayette, Indiana, 47905, United States
Unknown Facility
Boston, Massachusetts, 02114, United States
Unknown Facility
Boston, Massachusetts, 02215, United States
Unknown Facility
Danvers, Massachusetts, 01923, United States
Unknown Facility
New York, New York, 10016, United States
Unknown Facility
The Bronx, New York, 10461, United States
Unknown Facility
Philadelphia, Pennsylvania, 19111, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15224, United States
Unknown Facility
Nashville, Tennessee, 37203, United States
Unknown Facility
Nashville, Tennessee, 37232, United States
Unknown Facility
Fairfax, Virginia, 22031, United States
Unknown Facility
Seattle, Washington, 98101, United States
Unknown Facility
Toronto, Ontario, M5G 2M9, Canada
Centre Léon Bérard
Lyon, Auvergne-Rhône-Alpes, 69317, France
CHI Creteil
Créteil, Paris, 94010, France
Unknown Facility
München, Bavaria, 80336, Germany
Unknown Facility
Bad Berka, 99437, Germany
Unknown Facility
Berlin, 13353, Germany
Unknown Facility
Frankfurt, 60488, Germany
Unknown Facility
Oldenburg, 26121, Germany
Unknown Facility
Budapest, H-1121, Hungary
Unknown Facility
Miskolc, H-3529, Hungary
Unknown Facility
Tatabánya, H-2800, Hungary
Unknown Facility
Badalona, Barcelona, 08916, Spain
Unknown Facility
Majadahonda, Madrid, 28222, Spain
Unknown Facility
Barcelona, 08035, Spain
Unknown Facility
Madrid, 28007, Spain
Unknown Facility
Madrid, 28046, Spain
Unknown Facility
Málaga, 29010, Spain
Unknown Facility
Zaragoza, 50009, Spain
Related Publications (1)
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.
PMID: 30975923DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- VP, Clinical Operations
- Organization
- Elevation oncology
Study Officials
- STUDY DIRECTOR
MM-121 Program Medical Director, MD
Merrimack Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2015
First Posted
March 12, 2015
Study Start
February 1, 2015
Primary Completion
January 2, 2019
Study Completion
January 2, 2019
Last Updated
October 12, 2021
Results First Posted
October 12, 2021
Record last verified: 2021-10