Lung Cancer Clinical Trial

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

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.

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Full 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.

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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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

153

Study ID:

NCT02387216

Recruitment Status:

Terminated

Sponsor:

Elevation Oncology

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There are 35 Locations for this study

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Tucson Arizona, 85715, United States

Los Angeles California, 90033, United States

Santa Rosa California, 95403, United States

Tampa Florida, 33612, United States

Chicago Illinois, 60611, United States

Lafayette Indiana, 47905, United States

Boston Massachusetts, 02114, United States

Boston Massachusetts, 02215, United States

Danvers Massachusetts, 01923, United States

Bronx New York, 10461, United States

New York New York, 10016, United States

Philadelphia Pennsylvania, 19111, United States

Pittsburgh Pennsylvania, 15224, United States

Nashville Tennessee, 37203, United States

Nashville Tennessee, 37232, United States

Fairfax Virginia, 22031, United States

Seattle Washington, 98101, United States

Toronto Ontario, M5G 2, Canada
CHI Creteil
Créteil Paris, 94010, France
Centre Léon Bérard
Lyon cedex 08 Rhône-Alpes, 69317, France

Munchen Bayern, 80336, Germany

Bad Berka , 99437, Germany

Berlin , 13353, Germany

Frankfurt , 60488, Germany

Oldenburg , 26121, Germany

Budapest , H-112, Hungary

Miskolc , H-352, Hungary

Tatabanya , H-280, Hungary

Badalona Barcelona, 08916, Spain

Majadahonda Madrid, 28222, Spain

Barcelona , 08035, Spain

Madrid , 28007, Spain

Madrid , 28046, Spain

Malaga , 29010, Spain

Zaragoza , 50009, Spain

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

153

Study ID:

NCT02387216

Recruitment Status:

Terminated

Sponsor:


Elevation Oncology

How clear is this clinincal trial information?

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