STUDY OF EFFICACY AND SAFETY OF PEMBROLIZUMAB PLUS PLATINUM-BASED DOUBLET CHEMOTHERAPY WITH OR WITHOUT CANAKINUMAB IN PREVIOUSLY UNTREATED LOCALLY ADVANCED OR METASTATIC NON-SQUAMOUS AND SQUAMOUS NSCLC SUBJECTS
Not Applicable
- Conditions
- -C10 Malignant neoplasm of oropharynxMalignant neoplasm of oropharynxC10
- Registration Number
- PER-015-19
- Lead Sponsor
- OVARTIS BIOSCIENSES PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Histologically confirmed locally advanced or metastatic NSCLC
2.Measurable disease by RECIST 1.1
3. Known PD-L1 status
4. ECOG performance status (PS) 0 or 1
Exclusion Criteria
1. Previous immunotherapy or treatment with IL-1β inhibitor.
2. Subjects with epidermal growth factor receptor (EGFR) sensitizing mutations and/or
anaplastic lymphoma kinase (ALK) rearrangement
3. History of severe hypersensitivity reaction to monoclonal antibodies, platinum
containing drugs, nab-paclitaxel, paclitaxel, pemetrexed or any known excipients of
these drugs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Kaplan-Meier method<br>Measure:Progression Free Survival and Overall Survival<br>Timepoints:FS is defined as the time from the date of randomization to the date of the first documented disease progression<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Kaplan-Meier method<br>Measure:overall response rate<br>Timepoints:be performed not less than 4 weeks after the criteria for response are first met<br>