A Study of MTIG7192A in Combination With Atezolizumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/2/2019
Start Date:June 30, 2018
End Date:February 26, 2021
Contact:Reference Study ID Number: GO40290 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. Only)

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A Phase II, Randomized, Blinded, Placebo-Controlled Study of MTIG7192A, An Anti-TIGIT Antibody, In Combination With Atezolizumab In Chemotherapy-Naïve Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer

This study will evaluate the safety and efficacy of MTIG7192A plus Atezolizumab compared with
placebo plus atezolizumab in chemotherapy-naive patients with locally advanced unresectable
or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), excluding patients with a
sensitizing EGFR mutation or ALK translocation.


Inclusion Criteria:

- ECOG Performance Status of 0 or 1

- Histologically or cytologically documented locally advanced unresectable NSCLC,
recurrent, or metastatic NSCLC of either squamous or non-squamous histology

- No prior systemic treatment for locally advanced unresectable or metastatic NSCLC

- Tumor PD-L1 expression

- Measurable disease, as defined by RECIST v1.1

- Life expectancy >=12 weeks

- Adequate hematologic and end-organ function

- For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use contraceptive methods, and agreement to refrain from
donating eggs

- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use
contraceptive measures, and agreement to refrain from donating sperm

Exclusion Criteria:

Cancer-Specific Exclusions:

- Patients with NSCLC known to have a sensitizing mutation in the EGFR gene or an ALK
fusion oncogene

- Symptomatic, untreated, or actively progressing central nervous system (CNS)
metastases

- Spinal cord compression not definitively treated with surgery and/or radiation, and/or
previously diagnosed and treated spinal cord compression without evidence that disease
has been clinically stable for >=2 weeks prior to screening

- History of leptomeningeal disease

- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent
drainage procedures

- Uncontrolled tumor-related pain

- Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of
bisphosphonate therapy or denosumab

- Malignancies other than NSCLC within 5 years prior to randomization, with the
exception of those with a negligible risk of metastasis or death and/or treated with
expected curative outcome

General Medical Exclusions:

- Pregnant and lactating women

- Significant cardiovascular disease

- Severe infections within 4 weeks prior to randomization

- Major surgical procedure other than for diagnosis within 4 weeks prior to
randomization

Treatment-Specific Exclusions:

- History of severe allergic, anaphylactic, or other hypersensitivity reactions to
chimeric or humanized antibodies or fusion proteins; known hypersensitivity or allergy
to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the
atezolizumab formulation

- History of autoimmune disease

- Prior allogeneic bone marrow transplantation or solid organ transplantation

- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening
chest CT scan

- Positive test for human immunodeficiency virus (HIV) and/or active hepatitis B or
hepatitis C or active tuberculosis

- Administration of a live, attenuated vaccine within 4 weeks prior to randomization
We found this trial at
14
sites
2316 East Meyer Boulevard
Kansas City, Missouri 64132
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Angers,
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Arlington Heights, Illinois 60005
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Detroit, Michigan 48201
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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Fairfax, VA
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4371 Veronica S Shoemaker Boulevard
Fort Myers, Florida 33916
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Metairie, Louisiana 70006
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Metairie, LA
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Peoria, Illinois 61656
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Peoria, IL
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1201 5th Avenue North
Saint Petersburg, Florida 33705
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Saint Petersburg, FL
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Tallahassee, Florida 32308
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7695 South Research Drive
Tempe, Arizona 85284
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Vancouver, Washington 98684
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Vancouver, WA
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Westwood, Kansas 66205
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Westwood, KS
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