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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Novartis Pharmaceuticals

Affiliation: Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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