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Trial record 1 of 2 for:    MTIG7192A
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A Study of MTIG7192A in Combination With Atezolizumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03563716
Recruitment Status : Active, not recruiting
First Posted : June 20, 2018
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Atezolizumab Drug: MTIG7192A Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 30, 2018
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : February 26, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: MTIG7192A + atezolizumab
Participants will receive atezolizumab at a fixed dose of 1200 mg administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle and MTIG7192A at a dose of 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Drug: Atezolizumab
Atezolizumab at a fixed dose of 1200 mg will be administered first by IV infusion Q3W on Day 1 of each 21-day cycle.
Other Name: Tecentriq

Drug: MTIG7192A
MTIG7192A at a fixed dose of 600 mg will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Other Name: tiragolumab

Placebo Comparator: Placebo + atezolizumab
Participants will receive atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle and placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Drug: Atezolizumab
Atezolizumab at a fixed dose of 1200 mg will be administered first by IV infusion Q3W on Day 1 of each 21-day cycle.
Other Name: Tecentriq

Drug: Placebo
Placebo will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.




Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: Up to 5 years ]
    ORR, defined as a complete response or partial response on two consecutive occasions >=4 weeks apart, as determined by the investigator according to RECIST v1.1

  2. Progression Free Survival (PFS) [ Time Frame: Up to 5 years ]
    PFS, defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first


Secondary Outcome Measures :
  1. Duration of Objective Response (DOR) [ Time Frame: Up to 5 years ]
    DOR, defined as the time from the first occurrence of a documented objective response to disease progression, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first

  2. Overall Survival (OS) [ Time Frame: Up to 5 years ]
    OS, defined as the time from randomization to death from any cause

  3. Percentage of Participants With Adverse Events [ Time Frame: Up to 5 years ]
  4. Serum concentrations of MTIG7192A or atezolizumab [ Time Frame: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 12 Day 1 (each cycle is 21 days), at treatment discontinuation visit (up to 5 years). ]
  5. Perecentage of treatment-emergent anti-drug antibody-positive participants and anti-drug antibody-negative participants [ Time Frame: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 12 Day 1 (each cycle is 21 days), at treatment discontinuation visit (up to 5 years). ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03563716


  Hide Study Locations
Locations
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United States, Arizona
Arizona Oncology Associates, PC - HAL
Tempe, Arizona, United States, 85284
United States, Florida
SCRI Florida Cancer Specialists South
Fort Myers, Florida, United States, 33916
SCRI Florida Cancer Specialists North; Research Office North Region.
Saint Petersburg, Florida, United States, 33705
SCRI Florida Cancer Specialists East
Tallahassee, Florida, United States, 32308
United States, Illinois
Illinois Cancer Specialists
Arlington Heights, Illinois, United States, 60005
Illinois Cancer Care
Peoria, Illinois, United States, 61615
United States, Kansas
University of Kansas Medical Center
Westwood, Kansas, United States, 66205
United States, Louisiana
East Jefferson General Hospital
Metairie, Louisiana, United States, 70006
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Missouri
HCA Midwest Health
Kansas City, Missouri, United States, 64132
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Virginia
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
United States, Washington
Northwest Cancer Specialists - Vancouver
Vancouver, Washington, United States, 98684
France
ICO Paul Papin; Oncologie Medicale.
Angers, France, 49055
Institut Bergonié Centre Régional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest
Bordeaux, France, 33076
Centre Georges François Leclerc; Service Pharmacie, Bp 77980
Dijon, France, 21000
Hopital Nord AP-HM; Service Clinique des bronches allergies et sommeil
Marseille, France, 13015
Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)
Paris, France, 75475
Institut De Cancerologie De L'Ouest; Medical Oncology
Saint Herblain, France, 44115
Korea, Republic of
Chungbuk National University Hospital
Cheongju-si, Korea, Republic of, 28644
Seoul National University Bundang Hospital
Gyeonggi-do, Korea, Republic of, 13620
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Kangbuk Samsung Hospital
Seoul, Korea, Republic of, 03181
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 03722
Asan Medical Center - Oncology
Seoul, Korea, Republic of, 05505
Samsung Medical Center - PPDS
Seoul, Korea, Republic of, 06351
Serbia
Clinical Center of Serbia
Belgrade, Serbia, 11000
Institute for Oncology and Radiology of Serbia
Belgrade, Serbia, 11000
Clinical Hospital Center Bezanijska Kosa
Belgrade, Serbia, 11080
Institute of Lung Diseases Vojvodina
Sremska Kamenica, Serbia, 21204
Spain
Hospital Univ Germans Trias i Pujol
Badalona, Barcelona, Spain, 8916
Complejo Hospitalario Universitario Insular-Materno Infantil
Las Palmas de Gran Canaria, LAS Palmas, Spain, 35016
Clinica Universitaria de Navarra; Servicio de Oncologia
Pamplona, Navarra, Spain, 31008
Hospital General Universitario de Alicante
Alicante, Spain, 03010
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, Spain, 08035
Clinica Universitaria Navarra (Madrid)
Madrid, Spain, 28036
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Universitario Puerta de Hierro - Majadahonda
Madrid, Spain, 28222
Hospital Regional Universitario de Malaga - Hospital General; Servicio de Neurologia
Malaga, Spain, 29010
Centro Medico Quironsalud Sagrado Corazon
Sevilla, Spain, 41013
Hospital Universitario Virgen del Rocio
Sevilla, Spain, 41013
Taiwan
Taipei Medical University -Shuang Ho Hospital
New Taipei City, Taiwan, 23561
National Cheng Kung University Hospital; Internal Medicine
North Dist., Taiwan, 70403
Taichung Veterans General Hospital; Division of Hema-Oncology
Taichung, Taiwan, 40705
Taipei Veterans General Hospital
Taipei City, Taiwan, 112
National Taiwan University Hospital
Taipei, Taiwan, 10002
Chang Gung Memorial Hospital - Linkou
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Genentech, Inc.

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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT03563716     History of Changes
Other Study ID Numbers: GO40290
2018-000280-81 ( EudraCT Number )
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Atezolizumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs