Statements (81)
| Predicate | Object |
|---|---|
| gptkbp:instance_of |
gptkb:legal_case
|
| gptkbp:advocates_for |
informed consent required
obtained from all participants |
| gptkbp:analysis |
intention-to-treat analysis
|
| gptkbp:analyzes |
gptkb:Dr._Luis_Paz-Ares
|
| gptkbp:block |
double masking
|
| gptkbp:business_model |
obtained from relevant boards
|
| gptkbp:clinical_trial |
NC T02578680
|
| gptkbp:collaborations |
gptkb:Genentech
gptkb:temple gptkb:Bristol-Myers_Squibb gptkb:Roche various research institutions |
| gptkbp:collection |
clinical assessments
prospective data collection |
| gptkbp:committee |
gptkb:battle
|
| gptkbp:criteria |
patients with metastatic non-small cell lung cancer
previous treatment with anti-PD-1 or anti-PD-L1 therapy |
| gptkbp:events |
at least 24 months
long-term follow-up ongoing |
| gptkbp:field_of_study |
oncology
|
| gptkbp:focus |
chemotherapy
|
| gptkbp:focuses_on |
gptkb:healthcare_organization
|
| https://www.w3.org/2000/01/rdf-schema#label |
KEYNOTE-189 Trial
|
| gptkbp:impact |
changed treatment guidelines for lung cancer
|
| gptkbp:is_evaluated_by |
PD-L1 expression
|
| gptkbp:is_protected_by |
parallel assignment
|
| gptkbp:is_studied_in |
completed
completed in 2020 interventional study randomized, double-blind |
| gptkbp:is_tested_for |
Phase 3
|
| gptkbp:is_used_by |
gptkb:pembrolizumab
chemotherapy |
| gptkbp:launch_date |
gptkb:2017
2017-01-01 |
| gptkbp:location |
multiple sites worldwide
|
| gptkbp:members |
placebo
|
| gptkbp:notable_work |
pembrolizumab improves survival in NSCLC patients.
pembrolizumab plus chemotherapy is effective |
| gptkbp:participants |
overall survival
progression-free survival |
| gptkbp:population |
adults
diverse demographics |
| gptkbp:primary_source |
treatment
|
| gptkbp:provides_information_on |
data available upon request
influenced treatment guidelines for lung cancer |
| gptkbp:publishes |
gptkb:New_England_Journal_of_Medicine
|
| gptkbp:receives_funding_from |
gptkb:Company
|
| gptkbp:recorded_by |
gptkb:battle
1:1 ratio |
| gptkbp:regulatory_compliance |
EMA approval for pembrolizumab
FDA approval for pembrolizumab |
| gptkbp:research |
published in 2020
led to further research on pembrolizumab. significant clinical benefit |
| gptkbp:result |
gptkb:2020
improved overall survival improved progression-free survival improved overall survival compared to chemotherapy alone |
| gptkbp:safety_features |
ongoing safety monitoring
|
| gptkbp:side_effect |
fatigue
rash hypothyroidism pneumonitis monitored throughout the trial immune-mediated adverse events |
| gptkbp:sponsor |
gptkb:Merck_&_Co.
|
| gptkbp:student_enrollment |
adults aged 18 and older
approximately 616 patients measurable disease per RECIST 1.1 no prior systemic therapy for metastatic disease approximately 616 participants |
| gptkbp:target_audience |
patients with metastatic non-small cell lung cancer
|
| gptkbp:treatment |
gptkb:pembrolizumab
gptkb:vaccine pembrolizumab plus chemotherapy |
| gptkbp:vision |
double-blind
|
| gptkbp:year |
gptkb:2020
2019-01-01 2020-12-31 |