Switch Maintenance Pembrolizumab in Patients With NSCLC After First Line Platinum Doublet Chemotherapy

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).

Timeline

Start

2016-04-25

Primary completion

2023-05-02

Completion

2023-05-02

Publications

• Kakouri AC, Spiliotaki M, Loizidou EM, Stylianou I, Papageorgiou E, Panayi CG, Constantinou AI, Charalambous H, Deltas C, Papagregoriou G. Monitoring pembrolizumab response in patients with metastatic non-small cell lung cancer using circulating tumour DNA and circulating tumour cells. Transl Lung Cancer Res. 2025 Jun 30;14(6):1945-1960. doi: 10.21037/tlcr-2024-1095. Epub 2025 Jun 26.
• Charalambous H, Brown C, Vogazianos P, Katsaounou K, Nikolaou E, Stylianou I, Papageorgiou E, Vraxnos D, Aristodimou A, Chi J, Costeas P, Shammas C, Apidianakis Y, Antoniades A. Dysbiosis in the Gut Microbiome of Pembrolizumab-Treated Non-Small Lung Cancer Patients Compared to Healthy Controls Characterized Through Opportunistic Sampling. Thorac Cancer. 2025 May;16(9):e70075. doi: 10.1111/1759-7714.70075.

Drugs

Indications