Switch Maintenance Pembrolizumab in Patients With NSCLC After First Line Platinum Doublet Chemotherapy
NCT02705820 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2025-06-17
Summary
Single arm one stage Phase II study: post 4-6 cycles platinum doublet chemotherapy for patients with metastatic Non Small Cell Lung Cancer (NSCLC) offering Pembrolizumab as maintenance therapy to non-progressors with primary endpoint: Immune Related Progression Free Survival (irPFS) at 1 year. Aim to show that this is at least 25% (compared to an expected 12% 1 year PFS based on the Pemetrexed and Erlotinib maintenance trials).
Conditions
Interventions
- DRUG
-
Switch maintenance pembrolizumab treatment
Sponsors & Collaborators
- collaborator INDUSTRY
-
Bank of Cyprus Oncology Centre
lead OTHER
Principal Investigators
-
Dr Haris Charalambous, BM MRCP FRCR · Consultant Oncologist, BOC Oncology Centre
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-04-25
- Primary Completion
- 2023-05-02
- Completion
- 2023-05-02
Countries
- Cyprus
Study Locations
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