Study of Efficacy and Safety of Ociperlimab in Combination With Tislelizumab and Platinum-based Doublet Chemotherapy as First-line Treatment for Participants With Locally Advanced or Metastatic NSCLC.

Phase 3 Withdrawn Novartis Pharmaceuticals

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary scientific question of interest is whether the addition of ociperlimab to platinum-based chemotherapy and tislelizumab improve progression-free survival (PFS) or overall survival (OS) compared to pembrolizumab and platinum-based chemotherapy as first-line therapy for participants with locally advanced or metastatic squamous or non-squamous NSCLC with PD-L1 expression of ≥1%.

Timeline

Start: 2023-07-28
Primary completion: 2027-12-24
Completion: 2027-12-26

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ociperlimab	Monoclonal antibody	900 mg	Intravenous
Comparator	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous
Subject	Tislelizumab	Monoclonal antibody	200 mg	Intravenous
Background	Carboplatin	Small molecule	6 unknown	Intravenous
Background	Cisplatin	Other / unclassified	75 mg/m2	Intravenous
Background	Paclitaxel	Small molecule	100 mg/m2	Intravenous
Background	Paclitaxel	Small molecule	200 mg/m2	Intravenous
Background	Pemetrexed	Small molecule	500 mg/m2	Intravenous

Study of Efficacy and Safety of Ociperlimab in Combination With Tislelizumab and Platinum-based Doublet Chemotherapy as First-line Treatment for Participants With Locally Advanced or Metastatic NSCLC.

Summary

Timeline

Drugs

Indications