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) |
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.
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
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
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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3322 West End Avenue
Nashville, Tennessee 37203
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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1201 5th Avenue North
Saint Petersburg, Florida 33705
Saint Petersburg, Florida 33705
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