Active, not recruiting
April 22, 2019
April 1, 2021
This is a phase III, single-arm, multicenter study of the long-term safety and efficacy of atezolizumab treatment in patients with Stage IIIb or Stage IV non-small cell lung cancer (NSCLC) who have progressed following standard systemic chemotherapy (including if given in combination with anti-PD-1 therapy or after anti-PD-1 as monotherapy).
Participants will receive atezolizumab intravenously on the first day of each cycle. Atezolizumab treatment will continue until investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or patient decision to withdraw from therapy, or death (whichever occurs first).
Atezolizumab will be administered at a fixed dose of 1200 mg intravenously on the first day of each 21-day cycle.
- Histologically or cytologically documented Stage IIIb or Stage IV NSCLC that has
progressed following standard systemic chemotherapy (including if given in combination
with anti-PD-1 therapy or after anti-PD-1 as monotherapy). Patients with a previously
detected EGFR mutation or ALK fusion oncogene will be excluded from this study.
Overall, patients should not have received more than two lines of systemic
chemotherapy. Patients who have discontinued first-line or second-line systemic
chemotherapy, targeted therapy, or anti-PD-1 therapy due to intolerance are also
- The last dose of prior systemic anticancer therapy must have been administered ≥ 21
days prior to the first study treatment.
- The last dose of prior anti-PD-1 therapy must have been administered
- Measurable disease, as defined by Response Evaluation Criteria for Solid Tumors,
Version 1.1 (RECIST v1.1)
- Patients with asymptomatic CNS metastases (treated or untreated), as determined by CT
or MRI evaluation during screening and prior radiographic evaluation, are eligible
- ECOG performance status 0, 1, or 2
- Life expectancy ≥ 12 weeks
- Adequate hematologic and end-organ function
- For women of childbearing potential: agreement to remain abstinent or use
contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab - Patients must have recovered from all acute toxicities from previous therapy, excluding alopecia and toxicities related to prior anti-PD-1-therapy Exclusion Criteria: - Patients with EGFR mutation or ALK fusion oncogene - Symptomatic CNS metastases - 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 the first study treatment - Leptomeningeal disease - Uncontrolled pericardial effusion or ascites requiring recurrent drainage procedures - Pregnant or lactating, or intending to become pregnant during the study - Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol, including significant liver disease - Significant cardiovascular disease - Significant renal disorder requiring dialysis or indication for renal transplant - Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to study treatment initiation - Major surgical procedure within 4 weeks prior to study treatment initiation or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis - Prior allogeneic stem cell or solid organ transplantation
Peking Union Medical College Hospital
Sichuan Cancer Hospital
Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department
Harbin Medical University Tumor Hospital; Department of Surgery; Pharmacy
Taizhou Hospital of Zhejiang Province
Fudan University Shanghai Cancer Center; Medical Oncology
Cancer Hospital Affliated to Xinjiang Medical University
Study Director: Clinical Trials Hoffmann-La Roche