A PHASE III, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF MPDL3280A (ANTI-PD-L1 ANTIBODY) COMPARED WITH DOCETAXEL IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AFTER PLATINUM FAILURE

Phase 3

Completed

Conditions: iet kleincellig longcarcinoom
Lung cancer
non small cell lung cancer

Registration Number: NL-OMON44833

Lead Sponsor: Roche Nederland B.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

•Histologically or cytologically documented locally advanced or metastatic (i.e., Stage IIIB not eligible for definitive chemoradiotherapy, Stage IV, or recurrent) NSCLC ;•Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (preferred) or at least 15 unstained slides, with an associated pathology report, for central testing and determined to be evaluable for tumor PD-L1 expression prior to study enrollment;•Disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable/inoperable or metastatic NSCLC or disease recurrence within 6 months of treatment with a platinum-based adjuvant/neoadjuvant regimen ;•Measurable disease, as defined by RECIST v1.1;•ECOG performance status of 0 or 1;•Life expectancy > 12 weeks

Exclusion Criteria

•Received therapeutic oral or IV antibiotics within 2 weeks prior to randomization;•Major surgical procedure within 4 weeks prior to randomization or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis;•Administration of a live, attenuated vaccine within 4 weeks prior to randomization or anticipation that such a live attenuated vaccine will be required during the study;•Positive test for HIV

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy objective for this study is:<br /><br>* To determine if MPDL3280A treatment results in an improved overall survival<br /><br>(OS)<br /><br>compared with docetaxel treatment in patients with locally advanced or<br /><br>metastatic<br /><br>non-small cell lung cancer (NSCLC) who have progressed during or following a<br /><br>platinum-containing regimen<br /><br><br /><br>Comparisons of OS between the treatment arms within the PD-L1 staining<br /><br>categories and within the overall intent-to-treat (ITT) population will be<br /><br>tested using a sequentially rejective multiple testing procedure.<br /><br><br /><br>Safety Objectives<br /><br>The safety objectives for this study are as follows:<br /><br>* To evaluate the safety and tolerability of MPDL3280A compared with docetaxel<br /><br>* To evaluate the incidence of anti-therapeutic antibodies (ATAs) against<br /><br>MPDL3280A and to<br /><br>explore the potential</p><br>

Secondary Outcome Measures