A Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Docetaxel in Patients with Non-Small Cell Lung Cancer After Platinum Failure
- Conditions
- ON-SMALL CELL LUNG CANCER AFTER PLATINUM FAILUREMedDRA version: 19.1 Level: LLT Classification code 10029514 Term: Non-small cell lung cancer NOS System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-001142-34-GB
- Lead Sponsor
- F. Hoffmann-La Roche. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 287
- 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 < 1% per year during the treatment period and for 5 months after the last dose of atezolizumab
- Patients must have recovered from all acute toxicities from previous therapy, excluding alopecia
For patients in the docetaxel arm to cross over to receive atezolizumab:
- Patients must have recovered from acute toxicities (Grade <= 1) associated with prior cancer treatment with the exception of higher grade limits associated with specific laboratory result inclusion criteria listed for organ function tests
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 95
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 85
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 < 2.5 g/dL
- Positive test for HIV
- Patients with active hepatitis B or hepatitis C
- Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant liver disease
- Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 3 months prior to randomization, unstable arrhythmias, or unstable angina
- Active tuberculosis
- Severe infections within 4 weeks prior to randomization
- Major surgical procedure within 4 weeks prior to randomization or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis
- Administration of a live, attenuated vaccine within 4 weeks prior to randomization or anticipation that such a live attenuated vaccine will be required during the study
Exclusion criteria related to docetaxel:
- Prior treatment with docetaxel
- History of severe hypersensitivity to docetaxel or to other drugs formulated with polysorbate 80
- Grade >= 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
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