Phase
Condition
Neoplasms
Treatment
Osimertinib
5-Fluorouracil (5-FU)
Leucovorin
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
Life expectancy ≥ 12 weeks
Measurable disease per RECIST v1.1
Adequate organ and marrow function as defined in the protocol
Additional Inclusion Criteria for Module 1:
• Histologically or cytologically confirmed metastatic or locally advanced EGFRmut., NSCLC; metastatic EGFRwt. NSCLC; recurrent or metastatic HNSCC of the oral cavity; metastatic CRC.
Additional Inclusion Criteria for Module 2:
• Histologically or cytologically confirmed metastatic NSCLC EGFRmut.
Additional Inclusion Criteria for Module 3:
• Histologically or cytologically confirmed metastatic CRC.
Exclusion
Key Exclusion Criteria:
History of (non-infectious) ILD/pneumonitis that required steroids, has currentILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imagingat screening.
Spinal cord compression or a history of leptomeningeal carcinomatosis.
Active infection including tuberculosis and HBV, HCV or HIV
Brain metastases unless treated (prior treatment required only for Module 1),asymptomatic, stable, and not requiring continuous corticosteroids at a dose of > 10mg prednisone/day or equivalent for at least 4 weeks prior to start of studytreatment.
Participants with cardiac comorbidities as defined in the study protocol
Study Design
Connect with a study center
Research Site
Kogarah, 2217
AustraliaActive - Recruiting
Research Site
Melbourne, 3000
AustraliaActive - Recruiting
Research Site
Edmonton, Alberta T6G 1Z2
CanadaActive - Recruiting
Research Site
Toronto, Ontario M5G 1X6
CanadaActive - Recruiting
Research Site
Beijing, 100142
ChinaActive - Recruiting
Research Site
Chongqing, 400030
ChinaActive - Recruiting
Research Site
Guangzhou, 510100
ChinaActive - Recruiting
Research Site
Harbin, 150049
ChinaSite Not Available
Research Site
Wuhan, 430022
ChinaActive - Recruiting
Research Site
Marseille, 13385
FranceSite Not Available
Research Site
Rennes, 35000
FranceActive - Recruiting
Research Site
Villejuif Cedex, 94805
FranceActive - Recruiting
Research Site
Milano, 20162
ItalyActive - Recruiting
Research Site
Orbassano, 10043
ItalyActive - Recruiting
Research Site
Rozzano, 20089
ItalyActive - Recruiting
Research Site
Verona, 37134
ItalyActive - Recruiting
Research Site
Chuo-ku, 104-0045
JapanActive - Recruiting
Research Site
Kashiwa, 277-8577
JapanActive - Recruiting
Research Site
Koto-ku, 135-8550
JapanSite Not Available
Research Site
Seoul, 05505
Korea, Republic ofActive - Recruiting
Research Site
Kuala Lumpur, 59100
MalaysiaSite Not Available
Research Site
Kuching, 93586
MalaysiaActive - Recruiting
Research Site
Barcelona, 8035
SpainActive - Recruiting
Research Site
Madrid, 28040
SpainActive - Recruiting
Research Site
Sevilla, 41013
SpainActive - Recruiting
Research Site
Taichung, 40705
TaiwanActive - Recruiting
Research Site
Taipei, 10002
TaiwanActive - Recruiting
Research Site
Taipei City, 11217
TaiwanActive - Recruiting
Research Site
Taoyuan, 333
TaiwanActive - Recruiting
Research Site
Duarte, California 91010
United StatesActive - Recruiting
Research Site
Irvine, California 92618
United StatesActive - Recruiting
Research Site
North Haven, Connecticut 06473
United StatesActive - Recruiting
Research Site
Washington, District of Columbia 20016
United StatesSite Not Available
Research Site
Chicago, Illinois 60637
United StatesActive - Recruiting
Research Site
Baltimore, Maryland 21224
United StatesSite Not Available
Research Site
Milford, Massachusetts 01757
United StatesActive - Recruiting
Research Site
Mineola, New York 11501
United StatesActive - Recruiting
Research Site
New York, New York 10029
United StatesActive - Recruiting
Research Site
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Research Site
Providence, Rhode Island 02903
United StatesActive - Recruiting
Research Site
Houston, Texas 77030
United StatesActive - Recruiting
Research Site
Fairfax, Virginia 22031
United StatesActive - Recruiting
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