Phase
Condition
N/ATreatment
Nazartinib
Gefitinib
Osimertinib
Clinical Study ID
Ages 18-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria:
Participant is currently receiving capmatinib treatment (within Novartis-sponsoredstudy which is eligible and approved to transition participants to rollover study)as single agent or in combination or is receiving a combination treatment alone.This includes all participants treated with capmatinib in combination with othertreatment that permanently discontinued capmatinib for any reason but are stillreceiving the combination treatment as single agent. In order to receive thecombination treatment as single agent in the rollover study, the treatment needs tobe not accessible to the participant outside a clinical trial (e.g. commercially notavailable or reimbursed).
Participant is currently deriving clinical benefit from study treatment asdetermined by the Investigator
Willingness and ability to comply with scheduled visits, treatment plans and anyother study procedures
Written informed consent obtained prior to enrolling in the rollover study andreceiving study medication. If consent cannot be expressed in writing, it must beformally documented and witnessed, ideally via an independent trusted witness.
Exclusion
Exclusion criteria:
Participant is currently not receiving any study treatment due to unresolvedtoxicities for which study treatment dosing has been interrupted or permanentlydiscontinued in the parent protocol (participants meeting all other eligibilitycriteria may be enrolled once toxicities have resolved to allow study treatmentdosing to resume)
Pregnant or nursing (lactating) women
Women of child-bearing potential, defined as all women physiologically capable ofbecoming pregnant, unless they are using highly effective methods of contraceptionwhile taking study treatment and for at least 7 days or following combinationtreatment parent trial recommendation (whichever is longer) of study treatment afterstopping medication. Highly effective contraception methods include:
Concurrent participation in another clinical study other than a parent clinicalstudy
Participants who received live vaccines (e.g., intranasal influenza, measles, mumps,rubella, oral polio, BCG, yellow fever, varicella, TY21a typhoid vaccines andCOVID-19 vaccines) within 30 days prior to the first dose of study treatment
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Leuven, 3000
BelgiumSite Not Available
Novartis Investigative Site
Edmonton, Alberta T6G 1Z2
CanadaCompleted
Novartis Investigative Site
Shanghai, Shanghai 200433
ChinaActive - Recruiting
Novartis Investigative Site
Copenhagen, DK-2100
DenmarkCompleted
Novartis Investigative Site
Kobenhavn O, DK-2100
DenmarkSite Not Available
Novartis Investigative Site
Dijon, Cote D Or 21034
FranceCompleted
Novartis Investigative Site
Dijon Cedex, Cote D Or 21034
FranceSite Not Available
Novartis Investigative Site
Dresden, 01307
GermanySite Not Available
Novartis Investigative Site
Hannover, 30625
GermanySite Not Available
Novartis Investigative Site
Koeln, 50937
GermanySite Not Available
Novartis Investigative Site
Milano, MI 20141
ItalySite Not Available
Novartis Investigative Site
Perugia, PG 06129
ItalyCompleted
Novartis Investigative Site
Seoul, 05505
Korea, Republic ofSite Not Available
Novartis Investigative Site
Singapore, 119074
SingaporeSite Not Available
Novartis Investigative Site
Madrid, 28040
SpainCompleted
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
Massachusetts General Hospital MGH Cancer Center
Boston, Massachusetts 02114
United StatesActive - Recruiting
Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesSite Not Available
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