To determine the efficacy and safety of Nivolumab in combination with EGF816 and of Nivolumab in combination with INC280 in previously treated NSCLC patients
Name: EGF816
Type: DrugNivolumab and EGF816
Name: INC280
Type: DrugNivolumab and INC280
Name: Nivolumab
Type: DrugNivolumab and EGF816 Nivolumab and INC280
Description: Safety of EGF816 and Nivolumab and INC280 and Nivolumab by looking at hematology and chemistry laboratory parameters, vital signs, and electrocardiograms (ECGs)
Measure: Number of participants with Adverse Events (AEs) Time: Continuously during study until 100 days after post study treatmentParallel Assignment
There is one SNP
EGFR T790M positivity post progression on EGFR TKI for Group 1; cMet status for Group 2) must be provided for analysis Group 1 patients: - Patients with EGFR T790M NSCLC (adenocarcinoma) - Documented progression of disease according to RECIST v1.1 following primary standard of care (e.g. --- T790M ---
EGFR T790M positivity post progression on EGFR TKI for Group 1; cMet status for Group 2) must be provided for analysis Group 1 patients: - Patients with EGFR T790M NSCLC (adenocarcinoma) - Documented progression of disease according to RECIST v1.1 following primary standard of care (e.g. --- T790M --- --- T790M ---
Inhaled or topical steroids, and adrenal replacement steroid doses> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease - Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) - Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection - Patients with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity - Patients with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity Prior therapy: - Patients who have been treated with prior PD-1 and PD-L1 agents - Patients who previously received agents targeting c-MET and/or EGFR T790M Note: Previous treatment with afatinib may be allowable after discussions between Novartis and Investigator. --- T790M ---