Non-small cell lung cancer (NSCLC) MedDRA version: 21.1 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
F. Hoffman-La Roche Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age >= 18 years - Histologically or cytologically confirmed metastatic NSCLC - Documented radiographic disease progression during or following treatment with platinum-containing doublet chemotherapy and anti-PD-L1/PD-1 antibody, administered concurrently or sequentially for metastatic NSCLC - Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 outside the central nervous system (CNS) as assessed by investigator - Known PD-L1 status or availability of tumor tissue for central PD-L1 testing - Eastern Cooperative Oncology Group performance status score of 0 or 1 - Recovery to baseline or Grade =65 years) yes F.1.3.1 Number of subjects for this age range 175
Exclusion criteria
Exclusion criteria: - Prior therapy with the following agents for NSCLC: Cabo, Docetaxel, Combination of an anti-PD-L1/PD-1 antibody concurrently with a vascular endothelial growth factor -targeting tyrosine kinase inhibitor - Treatment with investigational therapy within 28 days prior to initiation of study treatment - Documentation of known sensitizing mutation in the epidermal growth factor receptor (EGFR) gene or anaplastic lymphoma kinase (ALK) fusion oncogene - Patients with known ROS-1 rearrangements, BRAF V600E mutations, or other actionable oncogenes with approved therapies if available - Symptomatic, untreated, or actively progressing CNS metastases - History of leptomeningeal disease - Uncontrolled tumor-related pain, pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures, uncontrolled or symptomatic hypercalcemia - Any other active malignancy at the time of initiation of study treatment or diagnosis of another malignancy within 3 years prior to initiation of study treatment that requires active treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, incidental prostate cancer, or carcinoma in situ of the prostate, cervix, or breast - Significant vascular disease (e.g., aortic aneurysm or arterial dissection requiring surgical repair or recent peripheral arterial thrombosis) within 6 months of initiation of study treatment - Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina - Stroke, transient ischemic attack, myocardial infarction or other symptomatic ischemic events within 6 months of initiation of study treatment - Active tuberculosis - Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety - Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment - Current treatment with anti-viral therapy for HBV - Ongoing Grade = 2 sensory or motor neuropathy - Active or history of autoimmune disease or immune deficiency - Pharmacologically uncompensated, symptomatic hypothyroidism - Administration of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab - Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives prior to initiation of study treatment - Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment - Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation - History of severe hypersensitivity to docetaxel or to other drugs formulated with polysorbate 80 - Concomitant anticoagulation with coumarin agents (e.g. warfarin), direct thrombin inhibitor dabigatran, direct factor Xa inhibitor betrixaban or platelet inhibitors (e.g. clopidogrel) - Thromboembolic event within 6 months before initiation of study treatment - History of risk factors for torsades de pointes - Corrected QT interval corrected through use of Fridericia's formula > 480 ms per ECG within 14 days before initiation of study treatment - U
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of atezolizumab in combination with cabozantinib compared with docetaxel monotherapy in patients with metastatic NSCLC who were previously treated with an anti-Programmed death-ligand 1 (PD-L1)/PD-1 antibody and platinum-containing chemotherapy;Secondary Objective: To evaluate the safety of atezolizumab and cabozantinib compared with docetaxel monotherapy in this patient population To characterize the pharmacokinetic (PK) profile of atezolizumab and cabozantinib To evaluate the immune response to atezolizumab and cabozantinib ;Primary end point(s): Overall Survival (OS);Timepoint(s) of evaluation of this end point: Up to approximately 47 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. PFS as determined by Investigator according to RECIST v1.1 2. Confirmed objective response rate (ORR) as determined by Investigator 3. Duration of response for patients with confirmed ORR 4. Time to confirmed deterioration in patient-reported physical functioning and global health status as measured by the corresponding scores from the European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life-Core 30 (QLQ-C30) 5. PFS rate assessed by IRF and Investigator at 6 months and at 1 year 6. OS rates at 1 and 2 years 7. Incidence and severity of adverse events according to NCI CTCAE v5.0 8. Serum concentration of atezolizumab at specified timepoints 9. Plasma concentration of cabozantinib at specified timepoints 10. Prevalence of anti-drug antibodies (ADAs) to atezolizumab at baseline and incidence of ADAs to atezolizumab after treatment ;Timepoint(s) of evaluation of this end point: 1-4. Up to approximately 47 months 5. At 6 months and at 1 year, up to approximately 47 months 6. At 1 and 2 years, up to approximately 47 months 7. Up to approximately 47 months 8. Day 1 of Cycle 1-5, Cycle 8, 12, 16, post treatment follow-up (<= 30 days after final dose) 9. Day 1 of Cycle 1-5 10. Day 1 of Cycle 1-4, Cycle 8, 12, 16, post treatment follow-up (<= 30 days after final dose) | — |
Countries
Australia, Austria, Belgium, France, Germany, Greece, Italy, Japan, Korea, Republic of, Poland, Portugal, Russian Federation, Spain, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
F.Hoffmann-La Roche Ltd.
Outcome results
None listed