A Phase III Clinical Study to Evaluate the Efficacy and Safety ofAtezolizumab in Combination with Carboplatin+Paclitaxel or Atezolizumab in Combination with Carboplatin+Nab-Paclitaxel Compared with Carboplatin+Nab-Paclitaxel in Patients with Stage IV Squamous Non-Small Cell Lung Cancer
- Conditions
- SQUAMOUS NON-SMALL CELL LUNG CANCERMedDRA version: 21.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-003208-59-DE
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1021
• Eastern Cooperative Oncology Group performance status of 0 or 1
• Histologically or cytologically confirmed Stage IV squamous NSCLC
Patients with tumors of mixed histology (squamous and non-squamous)
are eligible if the major histological component appears to be squamous.
• No prior treatment for Stage IV squamous NSCLC
Patients known to have a sensitizing mutation in the epidermal growth
factor receptor (EGFR) gene must have experienced disease progression
(during or after treatment) or intolerance to treatment with one or more
EGFR tyrosine kinase inhibitor (TKIs), such as erlotinib, gefitinib, or
another EGFR TKI appropriate for the treatment of EGFR-mutant NSCLC.
Patients with unknown EGFR mutation status do not require testing.
Patients known to have an anaplastic lymphoma kinase (ALK) fusion
oncogene must have experienced disease progression (during or after
treatment) or intolerance to treatment with one or more ALK inhibitors
(i.e., crizotinib) appropriate for the treatment of NSCLC in patients
having an ALK fusion oncogene.
Patients with unknown ALK mutation status do not require testing.
• Patients who have received prior neo-adjuvant, adjuvant
chemotherapy, radiotherapy, or chemoradiotherapy with curative intent
for non-metastatic disease must have experienced a treatment-free
interval of at least 6 months from randomization since the last
chemotherapy, radiotherapy, or chemoradiotherapy.
• Measurable disease, as defined by RECIST v1.1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 720
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 305
• Active or untreated CNS metastases as determined by CT or MRI
evaluation during screening and prior radiographic assessments
• Spinal cord compression not definitively treated with surgery and/or
radiation or previously diagnosed and treated spinal cord compression
without evidence that disease has been clinically stable for > 2 weeks
prior to randomization
• Leptomeningeal disease
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring
recurrent drainage procedures (once monthly or more frequently)
• History of severe allergic, anaphylactic, or other hypersensitivity
reactions to chimeric or humanized antibodies or fusion proteins
• Positive test for HIV
All patients will be tested for HIV prior to inclusion into the study;
patients who test positive for HIV will be excluded from the clinical.
• Uncontrolled tumor-related pain
• Uncontrolled or symptomatic hypercalcemia
• Malignancies other than NSCLC within 5 years prior to randomization,
with the exception of those with a negligible risk of metastasis or death
treated with expected curative outcome
• Known tumor PD-L1 expression status from other clinical trials
• Women who are pregnant, lactating, or intending to become pregnant
during the study
• Known hypersensitivity or allergy to biopharmaceuticals produced in
Chinese hamster ovary cells or any component of the atezolizumab
formulation
• History of autoimmune disease, including but not limited to
myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus
erythematosus, rheumatoid arthritis, inflammatory bowel disease,
vascular thrombosis associated with antiphospholipid syndrome,
Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré
syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
• History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g.,
bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT
scan
• Patients with active hepatitis B (chronic or acute; defined as having a
positive hepatitis B surface antigen [HBsAg] test at screening) or
hepatitis C
• Active tuberculosis
• Severe infections within 4 weeks prior to randomization, including but
not limited to hospitalization for complications of infection, bacteremia,
or severe pneumonia
• Received therapeutic oral or IV antibiotics within 2 weeks prior to
randomization
• Significant cardiovascular disease, such as New York Heart Association
cardiac disease (Class II or greater), myocardial infarction or
cerebrovascular accident within 3 months prior to randomization,
unstable arrhythmias, or unstable angina
• Major surgical procedure other than for diagnosis within 28 days prior
to randomization or anticipation of need for a major surgical procedure
during the course of the study
• Prior allogeneic bone marrow transplantation or solid organ transplant
• Administration of a live, attenuated vaccine within 4 weeks before
randomization or anticipation that such a live attenuated vaccine will be
required during the study
• Any other diseases, metabolic dysfunction, physical examination
finding, or clinical laboratory finding giving reasonable suspicion of a
disease or condition that contraindicates the use of an investigational
drug or that may affect the interpretation of the results or render the
patient at high risk from treatment complications
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method