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Non-Small Cell Lung CancerPhase 2SHERLOCNCT02387216

A Study of MM-121 in Combination With Chemotherapy Versus Chemotherapy Alone in Heregulin Positive NSCLC

A Phase 2 study testing MM-121 and Docetaxel in people with Non-Small Cell Lung Cancer and NSCLC, run by Elevation Oncology at 35 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer, NSCLC, Adenocarcinoma
What is being tested?
MM-121 and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
153 participants
Where
35 sitesin 6 countries
Study dates
1 Feb 2015to 2 Jan 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

35 sites in 6 countries.

35 sites in 6 countries

United States17 sites

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Boston, Massachusetts, 02215

  • Study site

    Chicago, Illinois, 60611

  • Study site

    Danvers, Massachusetts, 01923

  • Study site

    Fairfax, Virginia, 22031

  • Study site

    Lafayette, Indiana, 47905

  • Study site

    Los Angeles, California, 90033

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    Nashville, Tennessee, 37232

  • Study site

    New York, New York, 10016

  • Study site

    Philadelphia, Pennsylvania, 19111

  • Study site

    Pittsburgh, Pennsylvania, 15224

  • Study site

    Santa Rosa, California, 95403

  • Study site

    Seattle, Washington, 98101

  • Study site

    Tampa, Florida, 33612

  • Study site

    The Bronx, New York, 10461

  • Study site

    Tucson, Arizona, 85715

Other trials in United States

Spain7 sites

  • Study site

    Badalona, Barcelona, 08916

  • Study site

    Barcelona, 08035

  • Study site

    Madrid, 28007

  • Study site

    Madrid, 28046

  • Study site

    Majadahonda, Madrid, 28222

  • Study site

    Málaga, 29010

  • Study site

    Zaragoza, 50009

Other trials in Spain

Germany5 sites

  • Study site

    Bad Berka, 99437

  • Study site

    Berlin, 13353

  • Study site

    Frankfurt, 60488

  • Study site

    München, Bavaria, 80336

  • Study site

    Oldenburg, 26121

Other trials in Germany

Hungary3 sites

  • Study site

    Budapest, H-1121

  • Study site

    Miskolc, H-3529

  • Study site

    Tatabánya, H-2800

Other trials in Hungary

France2 sites

  • CHI Creteil

    Créteil, Paris, 94010

  • Centre Léon Bérard

    Lyon, Auvergne-Rhône-Alpes, 69317

Other trials in France

Canada1 site

  • Study site

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

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.)

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.

Read the 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.

Being tested
MM-121, Docetaxel
Keywords
NSCLC, Non-Small Cell Lung Cancer, heregulin, ErbB3, docetaxel
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Fibromatosis, Gingival, 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MM-121Drug

    Also called seribantumab

    Investigational, fully human antibody targeting and inhibiting ErbB3

  • DocetaxelDrug

    Also called Taxotere

    approved chemotherapy treatment for NSCLC

Study groups in NCT02387216
Study groupRoleWhat they receive
Arm A: Experimental ArmExperimentalMM-121 in combination with Docetaxel
Receives: Drug: MM-121; Drug: Docetaxel
Arm B: Comparator ArmActive comparatorDocetaxel alone
Receives: Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Randomization until progression of disease or death due to any cause within 3 years,11 months (the study terminated prematurely)

Secondary outcomes (6)

  1. Overall Survival

    Overall Survival (OS) is defined as the time from the date of randomization to the date of death from any cause

    Measured: From date of randomization until the date of death from any cause assessed upto 3 years,11 months (the study terminated prematurely)

  2. Objective Response Rate

    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

    Measured: Randomization through end of study up to 3 years, 11 months (the study terminated prematurely)

  3. Time to Progression

    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.

    Measured: Randomization to date of objective tumor progression up to 3 years, 11 months (the study terminated prematurely)

  4. Number of Participants With Treatment-emergent Adverse Events Reported With the Combination of MM-121 With Docetaxel Versus Docetaxel Alone

    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

    Measured: TEAEs were collected through the study completion (02 Jan 2019), up to 3 years, 11 months

  5. Pharmacokinetic (PK) Parameters of MM-121 in Combination With Docetaxel and Docetaxel When Given in Combination With MM-121.

    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.

    Measured: 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

  6. Percentage of Participants With Treatment-emergent Adverse Events Reported With the Combination of MM-121 With Docetaxel Versus Docetaxel Alone

    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

    Measured: TEAEs were collected through the study completion (02 Jan 2019), up to 3 years, 11 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2015 (estimated)
  2. Study start1 Feb 2015
  3. Primary completion2 Jan 2019
  4. Study completion2 Jan 2019

Why it stopped: Based on the preliminary results seen during interim analysis, which were confirmed in the final analysis, the Sponsor terminated the study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Model description
Randomized, open-label, international, multi-center, Phase 2 study in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
Masking
None (open label)
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02387216
Sponsor's protocol ID
MM-121-01-02-09
Acronym
SHERLOC
Status last verified
Oct 2021
First submitted
12 Feb 2015
Last updated
12 Oct 2021
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 30975923

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MM-121 and Docetaxel in people with Non-Small Cell Lung Cancer and NSCLC, run by Elevation Oncology at 35 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States, Spain, Germany, Hungary, France and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (time frame: Randomization until progression of disease or death due to any cause within 3 years,11 months (the study terminated prematurely)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02387216, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.

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