Novartis Investigative Site 60590 Frankfurt (Hessen) GermanyRekrutierend» Google-MapsNovartis Investigative Site 50924 Koeln (Nordrhein-Westfalen) GermanyRekrutierend» Google-MapsMassachusetts General Hospital Massachusetts General Hospital 02114 Boston United StatesRekrutierend» Google-Maps Ansprechpartner: Brian Kelter E-Mail: bkelter@partners.org» Ansprechpartner anzeigen
Dana Farber Cancer Institute . 02115 Boston United StatesRekrutierend» Google-Maps Ansprechpartner: Jennifer Luu Phone: 617-632-5136 E-Mail: Jennifer_Luu@DFCI.HARVARD.EDU» Ansprechpartner anzeigenWashington University School of Medicine 63110 Saint Louis United StatesRekrutierend» Google-Maps Ansprechpartner: Gina Vellequette E-Mail: g.vellequette@wustl.edu» Ansprechpartner anzeigenNYU School of Medicine NYU School of Med-Langone 10015 New York United StatesRekrutierend» Google-Maps Ansprechpartner: Selena Harrichand E-Mail: Selena.Harrichand@nyulangone.org» Ansprechpartner anzeigenMemorial Sloan Kettering Onc. Dept 10017 New York United StatesRekrutierend» Google-Maps Ansprechpartner: Paul Paik Phone: 646-608-3759 E-Mail: paikp@mskcc.org» Ansprechpartner anzeigenUni of TX MD Anderson Cancer Cntr 77030 Houston United StatesRekrutierend» Google-Maps Ansprechpartner:
Phone: 713-792-2921» Ansprechpartner anzeigenNovartis Investigative Site 104 0045 Chuo ku JapanRekrutierend» Google-MapsNovartis Investigative Site 03080 Seoul Korea, Republic ofRekrutierend» Google-MapsNovartis Investigative Site 08035 Barcelona SpainRekrutierend» Google-MapsNovartis Investigative Site CH 1211 Geneve 14 SwitzerlandRekrutierend» Google-Maps
1. Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (Time Frame - 28 months): Assessment of safety of study drug as a single agent
2. Frequency of dose interruptions and reductions (Time Frame - 28 months): Assessment of tolerability of study drug as a single agent
3. Dose intensity (Time Frame - 28 months): Dose intensity is defined as the ratio of actual cumulative dose received and actual duration of exposure.
4. Incidence and nature of dose limiting toxicities (DLTs) during the first 28 days of treatment with the study drug (Time Frame - 28 days): A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3 assessed as not primarily related to disease, disease progression, inter-current illness or concomitant medications that occurs during the first 28 days of treatment with the study drug. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
Secondary outcome:
1. Area under the concentration-time curve (AUC) (Time Frame - 20 months): Pharmacokinetics (PK) parameters will be determined by non-compartmental methods using the PK profile of the study drug.
2. Peak concentration (Cmax) (Time Frame - 20 months): Pharmacokinetics (PK) parameters will be determined by non-compartmental methods using the PK profile of the study drug.
3. Time to reach maximum drug concentrations in systemic circulation (Tmax) (Time Frame - 20 months): Pharmacokinetics (PK) parameters will be determined by non-compartmental methods using the PK profile of the study drug.
4. Overall response rate (ORR) per RECIST 1.1 (Time Frame - 28 months): Evaluation of preliminary anti-tumor activity of study drug as single agent
5. Progression free survival (PFS) per RECIST 1.1 (Time Frame - 28 months): Evaluation of preliminary anti-tumor activity of study drug as single agent
6. Duration of response (DOR) per RECIST 1.1 (Time Frame - 28 months): Evaluation of preliminary anti-tumor activity of study drug as single agent
Experimental: Dose escalation Patients with advanced NSCLC harboring NFE2L2/KEAP1/CUL3 mutations enrolled based on locally available test results of mutation status
Experimental: Dose expansion group 1 Patients with advanced NSCLC harboring NFE2L2/KEAP1/CUL3 mutations enrolled based on locally available test results of mutation status
Experimental: Dose expansion group 2 Patients with advanced NSCLC irrespective of prior knowledge of NFE2L2/KEAP1/CUL3 mutational status.