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Keytruda in PD-L1 Low Advanced NSCLC (PEOPLE)
NCT03447678Phase 2
Key facts
- Status
- Unknown
- Start
- May 2018
- Primary completion
- May 2022
- Countries
- 1
- Sponsor
- Fondazione IRCCS - Istituto Nazionale dei Tumori di Milano
- Modality
- Immune Checkpoint Inhibitors, Recombinant Proteins and Enzymes
- Drugs
- pembrolizumab
- Conditions
- non-small cell lung cancer (NSCLC)
01
Overview
Phase 2, open-label, single-arm trial of pembrolizumab in non-small cell lung cancer (NSCLC), sponsored by Fondazione IRCCS - Istituto Nazionale dei Tumori di Milano. Primary endpoint: Immune biomarkers at 3 years. Status: unknown.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Pembrolizumab Monotherapy
Subjects with PD-L1 low, EGFR wt, ALK negative NSCLC receiving pembrolizumab 200 mg Q3W.
03
Who it enrols
Patients with stage IIIB-IV NSCLC, PD-L1 expression <50%, EGFR wild-type, and ALK negative, who have not received prior systemic therapy for advanced disease.
04
Endpoints
Primary
Immune biomarkers
Secondary
Objective Response Rate
Progression-Free Survival
Overall Survival
Safety of Pembrolizumab treatment
Patient Reported health status
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