Non-small Cell Lung Cancer
Conditions
Brief summary
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).
Interventions
DRUGAtezolizumab
Atezolizumab will be administered at a fixed dose of 1200 mg intravenously on the first day of each 21-day cycle.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 eligible. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Event Incidence Rates | Baseline up to approximately 3 years | The incidence of serious adverse events (SAEs) related to atezolizumab. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | Baseline up to approximately 3 years | Overall survival (OS), defined as the time from initiation of study treatment to death from any cause |
| Progression-Free Survival (PFS) | Baseline up to approximately 3 years | Progression-free survival (PFS), defined as the time from initiation of study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first. |
| Objective Response Rate (ORR) | Baseline up to approximately 3 years | Objective response rate (ORR), defined as the percentage of patients who attain complete response (CR) or partial response (PR) according to RECIST v1.1 and also by disease status evaluated by the investigator according to modified RECIST |
| Overall Survival (OS) Rate | Baseline to 2 years | Overall survival (OS) rate at 2 years, defined as the proportion of patients remaining alive 2 years after initiation of study treatment |
| EQ-5D-5L Index-Based and VAS scores | Day 1 of first 3 cycles, then with tumor assessments every 6 weeks for 48 weeks from study treatment date; thereafter every 9 weeks until progressive disease or until treatment discontinuation (up to approximately 3 years) | EQ-5D-5L, EuroQol 5-Dimension Questionnaire is a self-report health status questionnaire that consists of six questions used to calculate a health utility score for use in health economic analysis. The EuroQol EQ-5D has two components: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort and anxiety/depression, as well as a visual analog scale (VAS) that measures health state. Overall scores range from 0 to 1, with low scores representing a higher level of dysfunction. |
| EORTC QLQ-LC13 score | Day 1 of first 3 cycles, then with tumor assessments every 6 weeks for 48 weeks from study treatment date; thereafter every 9 weeks until progressive disease or until treatment discontinuation (up to approximately 3 years) | EORTC QLQ-LC13, European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Supplemental Lung Cancer Module will be used to assess self-reported outcomes. EORTC QLQ-LC13 includes 13 items that address key lung cancer symptoms (cough, hemoptysis, dyspnea, and site-specific pain), treatment-related adverse effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. The dysphagia scale is multi-item, while the rest are single-item scales. |
| Duration of Response (DOR) | Baseline up to approximately 3 years | Duration of response (DOR), defined as the time from initial response to disease progression or death among patients who have experienced a CR or PR (unconfirmed) during the study. |
Countries
China
Outcome results
None listed