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Brief Title: 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
Official Title: A Phase II, Multicenter, Open-label Study of EGF816 in Combination With Nivolumab in Adult Patients With EGFR Mutated Non-small Cell Lung Cancer and of INC280 in Combination With Nivolumab in Adult Patients With cMet Positive Non-small Cell Lung Cancer
Study ID: NCT02323126
Brief 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
Detailed Description: This was a phase II, multi-center, open-label study in patients with advanced non-small cell lung cancer (NSCLC). Patients were allocated based on their epidermal growth factor receptor (EGFR) status to one of the 2 groups: Group 1 - EGFR T790M NSCLC treated with EGF816 150 mg once daily (QD) + nivolumab 3 mg/kg every 2 weeks (Q2W), and Group 2 - EGFR wild type (wt) NSCLC treated with INC280 400 mg twice daily (BID) + nivolumab 3 mg/kg Q2W. Patients in Group 2 were subdivided into 2 subgroups based on c-Mesenchymal-epithelial transition (cMet) status: Subgroup A - high cMet (referred to as Group 2A) and Subgroup B- low cMet (referred to as Group 2B). Patients could continue study treatment until patients experienced unacceptable toxicity that precluded any further treatment, disease progression and/or treatment was discontinued at the discretion of the investigator or withdrawal of consent, or the patient was transferred to a Novartis roll-over study or an alternative treatment option that could continue to provide study treatments. Following the approval of a protocol amendment, the maximum treatment duration for nivolumab could not exceed 2 years and patients who had received nivolumab beyond 2 years were discontinued from nivolumab treatment and continued on EGF816 or INC280 alone. The primary objective of the trial was to estimate the clinical activity of nivolumab in combination with EGF816 or INC280.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Texas MD Anderson Cancer Center Thoractic Head/Neck Med.Onc(2), Houston, Texas, United States
Novartis Investigative Site, Camperdown, New South Wales, Australia
Novartis Investigative Site, Chermside, Queensland, Australia
Novartis Investigative Site, La Tronche, , France
Novartis Investigative Site, Koeln, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Perugia, PG, Italy
Novartis Investigative Site, Aviano, PN, Italy
Novartis Investigative Site, Singapore, , Singapore
Novartis Investigative Site, Malaga, Andalucia, Spain
Novartis Investigative Site, Barcelona, Catalunya, Spain
Novartis Investigative Site, Alicante, Comunidad Valenciana, Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Chur, , Switzerland
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR