PDR001 in Combination With Platinum-doublet Chemotherapy and Other Immunology Agents in PD-L1 Unselected, Metastatic NSCLC Patients

Phase 1 Terminated 111 enrolled Novartis Pharmaceuticals

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The primary purpose of this study is to establish the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of PDR001 when administered in combination with platinum-doublet chemotherapy and other immunooncology agent(s) in treatment naive patients with PD-L1 unselected, advanced NSCLC, and to estimate the preliminary anti-tumor activity in this patient population.

Timeline

Start: 2017-05-24
Primary completion: 2021-07-28
Completion: 2021-07-28

Publications

Santoro A, Pilar G, Tan DSW, Zugazagoitia J, Shepherd FA, Bearz A, Barlesi F, Kim TM, Overbeck TR, Felip E, Cai C, Eddy S, McCulloch T, Schaefer ES. Spartalizumab in combination with platinum-doublet chemotherapy with or without canakinumab in patients with PD-L1-unselected, metastatic NSCLC. BMC Cancer. 2024 Oct 24;24(1):1307. doi: 10.1186/s12885-024-12841-2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Canakinumab	Monoclonal antibody	200 mg	Subcutaneous
Subject	Carboplatin	Small molecule	6 unknown	Intravenous
Subject	Cisplatin	Other / unclassified	75 mg/m2	Intravenous
Subject	Gemcitabine	Small molecule	1250 mg/m2	Intravenous
Subject	Paclitaxel	Small molecule	200 mg/m2	Intravenous
Subject	Pemetrexed	Small molecule	500 mg/m2	Intravenous
Subject	Spartalizumab	Monoclonal antibody	300 mg	—

PDR001 in Combination With Platinum-doublet Chemotherapy and Other Immunology Agents in PD-L1 Unselected, Metastatic NSCLC Patients

Summary

Timeline

Publications

Drugs

Indications