Stage IV squamous non-small cell lung cancer - Lung cancer
Conditions
Interventions
Investigational Medicinal Products Test Product (Investigational Drug)
MPDL3280A (1200 mg IV) will be administered on Day 1 of each 21-day cycle.
Non-Investigational Medicinal Products Comparator
-
Randomized
Squamous non-small cell lung cancer
Sponsors
Hoffmann-La Roche
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • ECOG performance status of 0 or 1 • Histologically or cytologically confirmed, Stage IV squamous NSCLC • No prior treatment for Stage IV squamous NSCLC Patients with a sensitizing mutation in the EGFR gene must have experienced disease progression (during or after treatment) or intolerance to treatment with erlotinib, gefitinib, or another EGFR tyrosine kinase inhibitor (TKI) appropriate for the treatment of EGFRmutant NSCLC. Patients with an ALK fusion oncogene must have experienced disease progression (during or after treatment) or intolerance to treatment with one or more ALK inhibitors (i.e. crizotinib) appropriate for the treatment of NSCLC in patients having an ALK fusion oncogene. • Patients who have received prior neo-adjuvant, adjuvant radiotherapy, chemotherapy, or chemoradiotherapy with curative intent for nonmetastatic disease must have experienced a treatment-free interval of at least 6 months from randomization since the last chemotherapy, radiotherapy or completion of chemoradiotherapy. • Measurable disease, as defined by RECIST v1.1
Exclusion criteria
Exclusion criteria: • Active or untreated CNS metastases as determined by CT or MRI 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 (once monthly or more frequently) • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins • Positive test for HIV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The co-primary efficacy outcome measures for this study are the following: • PFS, defined as the time from randomization to the first occurrence of the disease progression as determined by the investigator using RECIST v1.1 or death from any cause, whichever occurs first in the tGE population and ITT population • OS, defined as the time from randomization to death from any cause in the ITT population | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary efficacy outcome measures for this study are the following: • OS in the tGE population • PFS, as determined by the investigator according to RECIST v1.1, and OS in the TC2/3 or IC2/3 population and the TC1/2/3 or IC1/2/3 population • Objective response, defined as partial response (PR) or complete response (CR) as determined by the investigator according to RECIST v1.1 in the tGE population and ITT population • DOR, defined as the time interval from the first occurrence of a documented objective response to the time of disease progression as determined by the investigator using RECIST v1.1, or death from any cause, whichever occurs first in the tGE population and ITT population • OS rates at 1 and 2 years for the tGE population and ITT population • TTD in patient reported lung cancer symptoms, defined as time from randomization to deterioration (10 point change) on each of the EORTC QLQ-C30 and EORTC QLQ-LC13 symptom subscales (cough, dyspnea [single item], dyspnea [multi-item subscale], chest pain, and arm/shoulder pain) in the tGE population and ITT population • Change from baseline in patient reported lung cancer symptoms (cough, dyspnea, and chest pain) on the symptom severity score of the SILC scale in the tGE population and ITT population • PFS, as determined by the investigator according to RECIST v1.1, and OS in the two atezolizumab-containing arms in the tGE population and the ITT population | — |
Countries
The Netherlands
Outcome results
None listed