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
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
Click here to add this to my saved trials
1201 5th Avenue North
Saint Petersburg, Florida 33705
Saint Petersburg, Florida 33705
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials