Stage IV non-squamous non-small cell lung cancer - Lung cancer
Conditions
Interventions
Test Product (experimental drug)
- MPDL3280A (1200 mg IV) is administered on day 1 of each cycle of 21 days.
MPDL3280A is administered to patients randomized to groups A and B.
Non experimental dr
Non-squamous non-small cell lung cancer
Randomized
Sponsors
Hoffmann-La Roche
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - histologically or cytologically confirmed, Stage IV non-squamous NSCLC (per the Union Internationale contre le Cancer/American Joint Committee on Cancer staging system, 7th edition; Detterbeck et al. 2009). Patients with tumors of mixed histology (i.e., squamous and nonsquamous) are eligible if the major histological component appears to be non-squamous. - adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to randomization. - 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. - any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment; the following exceptions are allowed: * hormone-replacement therapy or oral contraceptives * TKIs approved for treatment of NSCLC discontinued > 7 days prior to randomization; the baseline scan must be obtained after discontinuation of prior TKIs. - women who are pregnant, lactating, or intending to become pregnant during the study. - history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
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 disease progression as determined by the investigator using RECIST v1.1 or death from any cause, whichever occurs first in the tGE-WT population and the ITT-WT population • OS, defined as the time from randomization to death from any cause in the ITT-WT population | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary efficacy outcome measures for this study are the following: • OS in the tGE WT population • PFS, as determined by the investigator according to RECIST v1.1, and OS in the TC2/3 or IC2/3 WT population and the TC1/2/3 or IC1/2/3 WT population • PFS, as determined by the investigator according to RECIST v1.1, and OS in the tGE population and the ITT population • Objective response, defined as partial response (PR) or complete response (CR) as determined by the investigator according to RECIST v1.1 1 in the tGE-WT population and the ITT-WT population • DOR, defined as the time interval from 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 1 in the tGE-WT population and the ITT-WT population • PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the IRF using RECIST v1.1 or death from any cause, whichever occurs first 1 in the tGE-WT population and the ITT-WT population • OS rates at 1 and 2 years 1 in the tGE-WT population and the ITT-WT population • PFS, as determined by the investigator according to RECIST v1.1, and OS in the two atezolizumab-containing arms in the tGE WT population and the ITT WT 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 in the tGE-WT population and the ITT-WT population • Change from baseline in patient reported lung cancer symptoms (chest pain, dyspnea, and cough) on the symptom severity score of the Symptoms in Lung Cancer scale in the tGE-WT population and the ITT-WT population | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, France, Germany, Israel, Italy, Latvia, Lithuania, Mexico, Netherlands, Peru, Portugal, Russian Federation, Slovakia, Spain, Sweden, Switzerland, Taiwan (Province of China), Ukraine, United States of America
Outcome results
None listed