Brief Summary
This randomized, open-label study was designed to evaluate and compare the safety and efficacy of atezolizumab with gemcitabine + cisplatin or carboplatin in PD-L1 selected participants with chemotherapy-naive, Stage IV squamous NSCLC. The study was closed due to low patient enrollment and the Sponsor's decision to include patients with squamous NSCLC into the GO29431 study, NCT02409342. Therefore the planned objectives of this study are no longer applicable and formal analyses of efficacy or safety have not been performed.
Brief Title
A Study of Atezolizumab Compared With Gemcitabine Plus (+) Cisplatin or Carboplatin for PD-L1-Selected Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower111)
Completion Date
Completion Date Type
Actual
Conditions
Non-Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
* Histologically or cytologically confirmed Stage IV squamous NSCLC
* Tumor programmed death-ligand 1 (PD-L1) expression, as determined by immunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained at screening
* No prior treatment for Stage IV squamous NSCLC
* Measurable disease as defined by RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Adequate hematologic and end-organ function
Exclusion Criteria:
* Active or untreated central nervous system (CNS) metastases
* Untreated or inadequately treated spinal cord compression
* Leptomeningeal disease
* Uncontrolled pleural effusion, pericardial effusion, or ascites
* Uncontrolled tumor-related pain
* Uncontrolled hypercalcemia
* Any other malignancies within 5 years except those with negligible risk of metastasis or death
* Pregnant or lactating women
* Known hypersensitivity to any component of atezolizumab formulation or other study medication
* History of autoimmune disease except controlled, treated hypothyroidism or type I diabetes
* Prior allogeneic bone marrow or solid organ transplantation
* Positive human immunodeficiency virus (HIV) test
* Active hepatitis B or C
* Active tuberculosis
* Significant cardiovascular disease
* Severe infection or major surgery within 4 weeks prior to randomization
* Use of any approved anti-cancer therapy within 3 weeks prior to treatment
* Use of an investigational agent or participation in another clinical trial within 4 weeks prior to randomization
* Exposure to oral or IV antibiotics within 2 weeks or live attenuated vaccines within 4 weeks prior to randomization
* Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies
* Treatment with immunostimulatory agents within 4 weeks or immunosuppressive agents within 2 weeks prior to randomization
* Histologically or cytologically confirmed Stage IV squamous NSCLC
* Tumor programmed death-ligand 1 (PD-L1) expression, as determined by immunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained at screening
* No prior treatment for Stage IV squamous NSCLC
* Measurable disease as defined by RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Adequate hematologic and end-organ function
Exclusion Criteria:
* Active or untreated central nervous system (CNS) metastases
* Untreated or inadequately treated spinal cord compression
* Leptomeningeal disease
* Uncontrolled pleural effusion, pericardial effusion, or ascites
* Uncontrolled tumor-related pain
* Uncontrolled hypercalcemia
* Any other malignancies within 5 years except those with negligible risk of metastasis or death
* Pregnant or lactating women
* Known hypersensitivity to any component of atezolizumab formulation or other study medication
* History of autoimmune disease except controlled, treated hypothyroidism or type I diabetes
* Prior allogeneic bone marrow or solid organ transplantation
* Positive human immunodeficiency virus (HIV) test
* Active hepatitis B or C
* Active tuberculosis
* Significant cardiovascular disease
* Severe infection or major surgery within 4 weeks prior to randomization
* Use of any approved anti-cancer therapy within 3 weeks prior to treatment
* Use of an investigational agent or participation in another clinical trial within 4 weeks prior to randomization
* Exposure to oral or IV antibiotics within 2 weeks or live attenuated vaccines within 4 weeks prior to randomization
* Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies
* Treatment with immunostimulatory agents within 4 weeks or immunosuppressive agents within 2 weeks prior to randomization
Inclusion Criteria
Inclusion Criteria:
* Histologically or cytologically confirmed Stage IV squamous NSCLC
* Tumor programmed death-ligand 1 (PD-L1) expression, as determined by immunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained at screening
* No prior treatment for Stage IV squamous NSCLC
* Measurable disease as defined by RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Adequate hematologic and end-organ function
* Histologically or cytologically confirmed Stage IV squamous NSCLC
* Tumor programmed death-ligand 1 (PD-L1) expression, as determined by immunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained at screening
* No prior treatment for Stage IV squamous NSCLC
* Measurable disease as defined by RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Adequate hematologic and end-organ function
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02409355
Org Class
Industry
Org Full Name
Hoffmann-La Roche
Org Study Id
GO29432
Overall Status
Terminated
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Phase III, Open-Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Compared With Gemcitabine+Cisplatin or Carboplatin for PD-L1-Selected, Chemotherapy Naive Patients With Stage IV Squamous Non-Small Cell Lung Cancer
Primary Outcomes
Outcome Measure
Progression-Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Outcome Time Frame
Baseline up to death or disease progression, whichever occurs first (up to approximately 2.5 years)
Secondary Ids
Secondary Id
2014-003106-33
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Haiying Cheng
Investigator Email
HCHENG@montefiore.org
Investigator Phone
718-405-8404
Categories Mesh Debug
Lung & Chest Cancers --- CARCINOMA, NON-SMALL-CELL LUNG
Lung & Chest Cancers --- CARCINOMA, BRONCHOGENIC
Lung & Chest Cancers --- BRONCHIAL NEOPLASMS
Lung & Chest Cancers --- LUNG NEOPLASMS
Lung & Chest Cancers --- RESPIRATORY TRACT NEOPLASMS
Lung & Chest Cancers --- THORACIC NEOPLASMS
Cancer --- NEOPLASMS BY SITE
Cancer --- NEOPLASMS
Lung & Chest Cancers --- LUNG DISEASES
COVID-19 --- LUNG DISEASES
Lung --- LUNG DISEASES
Asthma and Other Respiratory Diseases --- RESPIRATORY TRACT DISEASES
Lung & Chest Cancers --- RESPIRATORY TRACT DISEASES
COVID-19 --- RESPIRATORY TRACT DISEASES
Lung --- RESPIRATORY TRACT DISEASES
MeSH Terms
CARCINOMA, NON-SMALL-CELL LUNG
CARCINOMA, BRONCHOGENIC
BRONCHIAL NEOPLASMS
LUNG NEOPLASMS
RESPIRATORY TRACT NEOPLASMS
THORACIC NEOPLASMS
NEOPLASMS BY SITE
NEOPLASMS
LUNG DISEASES
RESPIRATORY TRACT DISEASES
ATEZOLIZUMAB
CARBOPLATIN
CISPLATIN
GEMCITABINE
COORDINATION COMPLEXES
ORGANIC CHEMICALS
CHLORINE COMPOUNDS
INORGANIC CHEMICALS
NITROGEN COMPOUNDS
PLATINUM COMPOUNDS
HETEROCYCLIC COMPOUNDS
DEOXYCYTIDINE
CYTIDINE
PYRIMIDINE NUCLEOSIDES
PYRIMIDINES
HETEROCYCLIC COMPOUNDS, 1-RING