NON-SMALL CELL LUNG CANCER AFTER PLATINUM FAILURE MedDRA version: 19.1 Level: LLT Classification code 10029514 Term: Non-small cell lung cancer NOS System Organ Class: 100000004864
Conditions
Interventions
Product Name: Not Applicable
Product Code: MPDL3280A-RO5541267
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Not Applicable
Sponsors
F. Hoffmann-La Roche. Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Aged >= 18 years - Histologically or cytologically documented locally advanced or metastatic NSCLC; pathological characterization must be sufficient to define patients as having either squamous or non-squamous histology - Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (preferred) or at least 15 unstained slides, with an associated pathology report, for central testing and determined to be evaluable for tumor programmed death-ligand 1 (PD-L1) expression prior to study enrollment; patients with fewer than 15 unstained slides available at baseline (but no fewer than 10) may be eligible following discussion with Medical Monitor - Disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable/inoperable or metastatic NSCLC or disease recurrence within 6 months of treatment with a platinum-based adjuvant/neoadjuvant regimen - Measurable disease, as defined by RECIST v1.1 - Eastern Cooperative Oncology Group performance status of 0 or 1 - Life expectancy >= 12 weeks - Adequate hematologic and end organ function - For female patients of childbearing potential agreement (by patient) remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of =65 years) yes F.1.3.1 Number of subjects for this age range 85
Exclusion criteria
Exclusion criteria: Cancer-specific exclusions: - Active or untreated central nervous system metastases as determined by Computerized tomography (CT) or Magnetic resonance imaging 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 - 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 treated with expected curative outcome General medical exclusions: - Pregnant and lactating women - History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins - Known hypersensitivity or allergy to Chinese hamster ovary cell-products or any component of the atezolizumab formulation - History of autoimmune disease - Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation - History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan - Serum albumin = 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTC AE) v4.0 criteria - Inability to discontinue use of strong CYP3A4 inhibitors Exclusion criteria related
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): 1. Overall Survival 2. Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.0 3. Changes in vital signs, physical findings, and clinical laboratory results 4. Incidence of ATA response to atezolizumab and potential correlation with PK, pharmacodynamics, safety, and efficacy parameters ; Main Objective: •To estimate the efficacy of atezolizumab compared with docetaxel as measured by overall survival (OS) •To evaluate the safety and tolerability of atezolizumab compared with docetaxel •To evaluate the incidence of anti-therapeutic antibodies (ATAs) against atezolizumab and to explore the potential relationship of the immunogenicity response with pharmacokinetics (PK), safety, and efficacy ; Secondary Objective: •To evaluate the efficacy of atezolizumab compared with docetaxel with respect to anti-tumor effects measured by overall response, duration of response (DOR), and progression free survival (PFS) per Response evaluation criteria in solid tumors (RECIST) v1.1 •To evaluate the efficacy of atezolizumab with respect to anti-tumor effects measured by overall response, DOR, and PFS per modified RECIST •To characterize the pharmacokinetics of atezolizumab •To evaluate and compare the patient reported outcomes (PROs) of lung cancer symptoms, patient functioning, and health-related quality of life (HRQoL) between treatment arms as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) and its Lung Cancer Module (LC13) ; Timepoint(s) of evaluation of this end point: 1. The time from randomization to death from any cause 2. Up to 90 days after last dose of atezolizumab 3. Up to 30 days after last dose of | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Overall response assessed by investigator using RECIST criteria v1.1 and modified RECIST criteria 2. Progression free survival assessed by investigator using RECIST criteria v1.1 and modified RECIST criteria 3. Duration of response assessed by investigator using RECIST criteria v1.1 and modified RECIST criteria 4. Maximum serum atezolizumab concentration 5. Minimum serum atezolizumab concentration 6. HRQoL and lung cancer symptoms as measured by the EORTC QLQ-C30 and QLQ-LC13 ; Timepoint(s) of evaluation of this end point: . At partial plus complete response 2. Up to first occurrence of disease progression or death from any cause 3. Time from first occurrence of documented objective response to the time of relapse 4. Day 1 of Cycle 1 (after infusion) 5. Day 1 (prior to infusion) of Cycles 1, 2, 3, 4, 8 and 16; at treatment discontinuation visit; and 120 days after last dose of atezolizumab 6. Up to 30 days after last dose of atezolizumab | — |
Countries
Belgium, Canada, France, Germany, Hungary, Italy, Poland, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TSIL
F. Hoffmann-La Roche Ltd.
Outcome results
None listed