A PHASE II, 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
- Conditions
- ON-SMALL CELL LUNG CANCER AFTER PLATINUM FAILUREMedDRA version: 16.0Level: LLTClassification code 10029514Term: Non-small cell lung cancer NOSSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-001142-34-IT
- Lead Sponsor
- F. Hoffmann-La Roche. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 287
•patients must have failed a prior platinum-containing regimen.
•Histologically or cytologically documented locally advanced or metastatic (i.e., Stage IIIB not eligible for definitive chemoradiotherapy, Stage IV, or recurrent) NSCLC (per the UICC/AJCC staging system, 7th edition; Detterbeck et al. 2009); pathological characterization must be sufficient to define patients as having either squamous or non-squamous histology.
•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; patients with fewer than 15 unstained slides available at baseline (but no fewer than 10) may be eligible following discussion with Medical Monitor.
• Measurable disease, as defined by RECIST v1.1
• ECOG performance status of 0 or 1
• Life expectancy > 12 weeks
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 95
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 85
• Known active or untreated central nervous system (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 randomization
• Leptomeningeal disease
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
• Uncontrolled tumor-related pain
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: • To estimate the efficacy of MPDL3280A compared with docetaxel as measured by OS <br>•To evaluate the safety and tolerability of MPDL3280A compared with docetaxel;Secondary Objective: •To evaluate the efficacy of MPDL3280A compared with docetaxel with respect to anti-tumor effects measured by overall response, DOR, and PFS per RECIST v1.1<br>•To evaluate the efficacy of MPDL3280A with respect to anti-tumor effects measured by overall response, DOR, and PFS per modified RECIST<br>;Primary end point(s): • OS, defined as the time from randomization to death from any cause;Timepoint(s) of evaluation of this end point: See E.5.1
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Overall response (partial response plus complete response), as determined by investigator using RECIST v1.1 criteria<br>• PFS, defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator using RECIST v1.1 criteria, or death from any cause<br>;Timepoint(s) of evaluation of this end point: See E.5.2