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



Status:Recruiting
Conditions:Lung Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:5/3/2018
Start Date:February 2015
End Date:December 2018

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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.

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.

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
We found this trial at
18
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Nashville, Tennessee 37232
Phone: 800-811-8480
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Boston, Massachusetts
Phone: 617-632-7889
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Bronx, New York
Phone: 718-405-8539
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Chicago, Illinois
Phone: 312-926-4248
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Chicago, IL
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Danvers, Massachusetts 01923
Phone: 978-882-6034
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Fairfax, Virginia 22031
Phone: 571-389-0873
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Lafayette, Indiana 47904
Phone: 765-446-5111
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Los Angeles, California
Phone: 323-865-0421
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New York, New York 10032
Phone: 212-731-5111
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Philadelphia, Pennsylvania
Phone: 215-728-2586
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Pittsburgh, Pennsylvania
Phone: 412-578-5393
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Santa Rosa, California 95405
Phone: 707-521-3814
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Seattle, Washington 98105
Phone: 206-342-6926
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Tampa, Florida
Phone: 813-745-4625
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Toronto, Ontario
Phone: (416) 581-7804
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Tucson, Arizona 85724
Phone: 520-290-2510
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