A phase III clinical study to evaluate the efficacy and safety of MPDL3280A in combination with carboplatin + nab-paclitaxel and MPDL328-A in combination with carboplatin + paclitaxel in stage IV squamous non-small cell lung cancer patients.
- Conditions
- SQUAMOUS NON-SMALL CELL LUNG CANCERTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-003208-59-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
- 1021
• 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 EGFR-mutant 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 chemotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 6 months from randomization since the last chemotherapy or completion of chemoradiotherapy.
• Measurable disease, as defined by RECIST v1.1
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 720
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 480
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method