A PHASE III, OPEN-LABEL, RANDOMIZED STUDY OF ATEZOLIZUNAB (MPDL3280A, ANTI*PD-L1 ANTIBODY) IN COMBINATION WITH CARBOPLATIN + PACLITAXEL WITH OR WITHOUT BEVACIZUMAB COMPARED WITH CARBOPLATIN + PACLITAXEL + BEVACIZUMAB IN CHEMOTHERAPY-NAiVE<br>PATIENTS WITH STAGE IV NON-SQUAMOUS NON*SMALL CELL LUNG CANCER.
- Conditions
- Stage IV non-squamous non-small cell lung cancer - Lung cancer10038666
- Registration Number
- NL-OMON47780
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 89
- 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
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The co-primary efficacy outcome measures for this study are the following:<br /><br>• PFS, defined as the time from randomization to the first occurrence of<br /><br>disease progression as determined by the investigator using RECIST v1.1 or<br /><br>death from any cause, whichever occurs first in the tGE-WT population and the<br /><br>ITT-WT population<br /><br>• OS, defined as the time from randomization to death from any cause in the<br /><br>ITT-WT population</p><br>
- Secondary Outcome Measures
Name Time Method