Study of Safety and Efficacy of EGFR-TKI EGF816 in Combination With cMET Inhibitor INC280 in Adult Patients With EGFR Mutated Non Small Cell Lung Cancer.

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

177

Participants

Timeline

Start Date

January 13, 2015

Primary Completion Date

November 10, 2020

Study Completion Date

November 10, 2020

Conditions
Non Small Cell Lung Cancer
Interventions
DRUG

Capmatinib

"In the Phase 1, capmatinib was administered orally, twice per day, at a dose of 200 mg or 400 mg, in fasted state.~In the Phase II, participants received capmatinib at the RP2D (400 mg twice per day) in fasted state (Groups 1, 2 and 3) or fed state (Group 4).~Participants in Phase II Group 5 were to start with capmatinib monotherapy (fasted or fed state) and then would have had the opportunity to continue with the combination of nazartinib and capmatinib (fasted or fed state)."

DRUG

Nazartinib

"In the Phase 1, nazartinib was administered orally, once a day, at a dose of 50 mg, 75 mg, 100 mg or 150 mg in fasted state.~In the Phase II, participants received nazartinib at the RP2D (100 mg once daily) in fasted state (Groups 1, 2 and 3) or fed state (Group 4). Participants in Phase II Group 5 were to start with capmatinib monotherapy (fasted or fed state) and then would have had the opportunity to continue with the combination of nazartinib and capmatinib (fasted or fed state)."

Trial Locations (19)

3000

Novartis Investigative Site, Melbourne

10041

Novartis Investigative Site, Taipei

13885

Novartis Investigative Site, Marseille

15006

Novartis Investigative Site, A Coruña

28009

Novartis Investigative Site, Madrid

28041

Novartis Investigative Site, Madrid

35016

Novartis Investigative Site, Las Palmas de Gran Canarias

40138

Novartis Investigative Site, Bologna

41124

Novartis Investigative Site, Modena

50937

Novartis Investigative Site, Cologne

69126

Novartis Investigative Site, Heidelberg

119228

Novartis Investigative Site, Singapore

168583

Novartis Investigative Site, Singapore

02114

Massachusetts General Hospital Mass General, Boston

T6G 1Z2

Novartis Investigative Site, Edmonton

06129

Novartis Investigative Site, Perugia

NO 0424

Novartis Investigative Site, Oslo

05505

Novartis Investigative Site, Seoul

08035

Novartis Investigative Site, Barcelona

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY