Study of Efficacy and Safety of Nivolumab in Combination With EGF816 and of Nivolumab in Combination With INC280 in Patients With Previously Treated Non-small Cell Lung Cancer

Phase 2 Terminated 64 enrolled Novartis Pharmaceuticals

Non-randomizedParallel-groupOpen-labelTreatment

Summary

To determine the efficacy and safety of nivolumab in combination with EGF816 and of nivolumab in combination with INC280 in previously treated NSCLC patients

Timeline

Start: 2015-02-09
Primary completion: 2019-09-23
Completion: 2021-02-05

Outcome

Met primary endpoint

Stopped (Enrollment): “Sponsor decision due to low patient recruitment caused by the change in the treatment landscape of NSCLC.”

paper The primary endpoint was met in both the high-MET (N = 16) and low-MET (N = 30) groups. PMID 38763104 ↗

Publications

Felip E, Metro G, Tan DSW, Wolf J, Mark M, Boyer M, Hughes BGM, Bearz A, Moro-Sibilot D, Le X, Puente J, Massuti B, Tiedt R, Wang Y, Xu C, Mardjuadi FI, Cobo M. Capmatinib plus nivolumab in pretreated patients with EGFR wild-type advanced non-small cell lung cancer. Lung Cancer. 2024 Jun;192:107820. doi: 10.1016/j.lungcan.2024.107820. Epub 2024 May 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Capmatinib	Small molecule	400 mg	Oral
Subject	Nazartinib	Small molecule	150 mg	Oral
Subject	Nivolumab	Monoclonal antibody	3 mg/kg	Intravenous