Tepotinib Phase II in Non-small Cell Lung Cancer (NSCLC) Harboring MET Alterations



Status:Recruiting
Conditions:Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/23/2018
Start Date:September 13, 2016
End Date:December 31, 2019
Contact:US Medical Information
Phone:888-275-7376

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A Phase II, Single-arm Trial to Investigate Tepotinib in Advanced (Stage IIIB/IV) Non-small Cell Lung Cancer With MET Exon 14 (METex14) Skipping Alterations or MET Amplification (VISION)

This study will look at how effective the study drug (tepotinib) is at stopping the growth
and spread of lung cancer. This study will also measure a number of other things including
safety of the study drug and the side effects, how body processes the study drug, or how the
study drug affects your quality of life. The study also has an optional pharmacogenetic
research part. Pharmacogenetic research is an important way to try to understand the role of
genetics in human disease and how genes impact the effectiveness of drugs, because
differences in genes can change the way a person responds to a particular drug.


Inclusion Criteria:

- Signed, written informed consent by subject or legal representative prior to any
trial-specific screening procedure

- Male or female, greater than or equal to (>=) 18 years of age (or having reached the
age of majority according to local laws and regulations

- Measurable disease in accordance with RECIST version 1.1

- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1

- A female subject is eligible to participate if she is not pregnant, not breastfeeding,
and at least one of the following conditions applies:

- Not a woman of childbearing potential OR

- A woman of childbearing potential who agrees to use a highly effective contraception

- A male subject must agree to use and to have their female partners of childbearing
potential to use a highly effective contraception

- Histologically confirmed advanced (Stage IIIB/IV) Non-small Cell Lung Cancer (NSCLC)
(all histologies including squamous and sarcomatoid)

- Treatment naïve patients in first-line or pretreated patients with no more than 2
lines of prior therapy

- Subjects with MET alterations, namely METex14 skipping alterations in plasma and/or
tissue, or MET amplification only in plasma and/or tumor biopsy samplet

Exclusion Criteria:

- Subjects with characterized Epidermal Growth Factor Receptor (EGFR) activating
mutations that predict sensitivity to anti-EGFR-therapy

- Subjects with characterized Anaplastic Lymphoma Kinase (ALK) rearrangements that
predict sensitivity to anti-ALK therapy

- Active brain metastases

- Any unresolved toxicity Grade 2 or more according to National Cancer Institute Common
Terminology Criteria for Adverse Events (NCI-CTCAE) from previous anticancer therapy

- Need for transfusion within 14 days prior to the first dose of trial treatment

- Prior chemotherapy, biological therapy, radiation therapy, hormonal therapy for
anti-cancer purposes, targeted therapy, or other investigational anticancer therapy
(not including palliative radiotherapy at focal sites) within 21 days prior to the
first dose of trial treatment;

- Subjects who have brain metastasis as the only measurable lesion

- Inadequate hematological, liver, renal, cardiac function

- Prior treatment with other agents targeting the Hepatocyte Growth Factor c(HGF/c) -Met
pathway

- Hypertension uncontrolled by standard therapies (not stabilized to < 150/90 mmHg)

- Past or current history of neoplasm other than Non-small Cell Lung Cancer (NSCLC),
except for curatively treated non-melanoma skin cancer, in situ carcinoma of the
cervix, or other cancer curatively treated and with no evidence of disease for at
least 5 years

- Medical history of difficulty swallowing, malabsorption, or other chronic
gastrointestinal disease, or conditions that may hamper compliance and/or absorption
of the test product

- Major surgery within 28 days prior to Day 1 of trial treatment

- Known infection with human immunodeficiency virus, or an active infection with
hepatitis B or hepatitis C virus

- Substance abuse, active infection, or other acute or chronic medical or psychiatric
condition or laboratory abnormalities that might increase the risk associated with
trial participation at the discretion of Investigators

- Known hypersensitivity to any of the trial treatment ingredients

- Legal incapacity or limited legal capacity

- Any other reason that, in the opinion of the Principal Investigator, precludes the
subject from participating in the trial

- Participation in another clinical trial within the past 30 days
We found this trial at
26
sites
8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Principal Investigator: Alexander Spira
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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4725 North Federal Highway
Fort Lauderdale, Florida 33308
(954) 771-8000
Principal Investigator: David Drew
Phone: 954-267-7742
Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
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Fort Lauderdale, FL
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Leora Horn
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Athens, Georgia 30607
Principal Investigator: Petros Nikolinakos
Phone: 706-353-2990
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Atlanta, Georgia 30322
Principal Investigator: Conor Steuer
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Austin, Texas 78705
Principal Investigator: James Uyeki
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Beaumont, Texas 77702
Principal Investigator: Jesse Medellin
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Bridgeton, Missouri 63044
Principal Investigator: Juan Cuevas
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
Principal Investigator: Jyoti Patel
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Chicago, IL
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Cincinnati, Ohio 45206
Principal Investigator: John Morris
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Dallas, Texas 75246
Principal Investigator: Kartik Konduri
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Denver, Colorado 80218
Principal Investigator: Robert Jotte
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Duarte, California 91010
Principal Investigator: Ravi Salgia
Phone: 626-218-3712
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Edegem, 2650
Principal Investigator: Jan Van Meerbeeck
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30 Prospect Avenue
Hackensack, New Jersey 07601
Principal Investigator: Harry Harper
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Harvey, Illinois 60426
Principal Investigator: Mark Kozloff
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Principal Investigator: Xiuning Le
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Indianapolis, Indiana 46256
Principal Investigator: Rhadika Walling
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Principal Investigator: Melissa Johnson
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Paul Paik
Phone: 646-888-4202
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Orange, California 92686
Principal Investigator: Sai-Hong Ou
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Redondo Beach, California 90277
Principal Investigator: Andrew Horodner
Phone: 310-750-3300
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223 N Van Dien Ave
Ridgewood, New Jersey 07450
(201) 447-8000
Principal Investigator: Eli Kirshner
The Valley Hospital The Valley Hospital is a fully accredited, acute care, not-for-profit hospital serving...
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Saint Louis, Missouri 63110
Principal Investigator: Nishant Poddar
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Principal Investigator: Howard West
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Wenatchee, Washington 98801
Principal Investigator: Lindsay Overton
Phone: 509-663-8711
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