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
Kogarah 2161185, 2217
AustraliaSite Not Available
Research Site
Melbourne, 3000
AustraliaActive - Recruiting
Research Site
Melbourne 2158177, 3000
AustraliaSite Not Available
Research Site
Edmonton, Alberta T6G 1Z2
CanadaActive - Recruiting
Research Site
Edmonton 5946768, Alberta 5883102 T6G 1Z2
CanadaSite Not Available
Research Site
Toronto, Ontario M5G 1X6
CanadaActive - Recruiting
Research Site
Toronto 6167865, Ontario 6093943 M5G 1X6
CanadaSite Not Available
Research Site
Beijing, 100142
ChinaActive - Recruiting
Research Site
Beijing 1816670, 100142
ChinaSite Not Available
Research Site
Chongqing, 400030
ChinaActive - Recruiting
Research Site
Chongqing 1814906, 400030
ChinaSite Not Available
Research Site
Guangzhou, 510100
ChinaActive - Recruiting
Research Site
Guangzhou 1809858, 510100
ChinaSite Not Available
Research Site
Harbin, 150049
ChinaSite Not Available
Research Site
Harbin 2037013, 150049
ChinaSite Not Available
Research Site
Wuhan, 430022
ChinaActive - Recruiting
Research Site
Wuhan 1791247, 430022
ChinaSite Not Available
Research Site
Marseille, 13385
FranceActive - Recruiting
Research Site
Marseille 2995469, 13385
FranceSite Not Available
Research Site
Rennes, 35000
FranceActive - Recruiting
Research Site
Rennes 2983990, 35000
FranceSite Not Available
Research Site
Villejuif, 94805
FranceActive - Recruiting
Research Site
Villejuif 2968705, 94805
FranceSite Not Available
Research Site
Villejuif Cedex, 94805
FranceSite Not Available
Research Site
Milan, 20162
ItalyActive - Recruiting
Research Site
Milan 6951411, 20162
ItalySite Not Available
Research Site
Milano, 20162
ItalySite Not Available
Research Site
Orbassano, 10043
ItalyActive - Recruiting
Research Site
Orbassano 3171986, 10043
ItalySite Not Available
Research Site
Rozzano, 20089
ItalyActive - Recruiting
Research Site
Rozzano 3168837, 20089
ItalySite Not Available
Research Site
Verona, 37134
ItalyActive - Recruiting
Research Site
Verona 3164527, 37134
ItalySite Not Available
Research Site
Chuo-ku, 104-0045
JapanSite Not Available
Research Site
Chūōku, 104-0045
JapanActive - Recruiting
Research Site
Chūōku 10262791, 104-0045
JapanSite Not Available
Research Site
Kashiwa, 277-8577
JapanActive - Recruiting
Research Site
Kashiwa 1859924, 277-8577
JapanSite Not Available
Research Site
Koto-ku, 135-8550
JapanSite Not Available
Research Site
Kōtoku, 135-8550
JapanActive - Recruiting
Research Site
Kōtoku 2128852, 135-8550
JapanSite Not Available
Research Site
Osaka, 541-8567
JapanActive - Recruiting
Research Site
Osaka 1853909, 541-8567
JapanSite Not Available
Research Site
Osaka-shi, 541-8567
JapanSite Not Available
Research Site
Seoul, 03080
Korea, Republic ofSite Not Available
Research Site
Kuala Lumpur, 59100
MalaysiaActive - Recruiting
Research Site
Kuala Lumpur 1735161, 59100
MalaysiaSite Not Available
Research Site
Kuching, 93586
MalaysiaActive - Recruiting
Research Site
Kuching 1735634, 93586
MalaysiaSite Not Available
Research Site
Seoul, 06351
South KoreaActive - Recruiting
Research Site
Seoul 1835848, 03080
South KoreaSite Not Available
Research Site
Barcelona, 8035
SpainActive - Recruiting
Research Site
Barcelona 3128760, 8035
SpainSite Not Available
Research Site
Madrid, 28040
SpainActive - Recruiting
Research Site
Madrid 3117735, 28040
SpainSite Not Available
Research Site
Sevilla, 41013
SpainSite Not Available
Research Site
Seville, 41013
SpainActive - Recruiting
Research Site
Seville 2510911, 41013
SpainSite Not Available
Research Site
Taichung, 40705
TaiwanActive - Recruiting
Research Site
Taichung 1668399, 40705
TaiwanSite Not Available
Research Site
Taipei, 11217
TaiwanActive - Recruiting
Research Site
Taipei 1668341, 10002
TaiwanSite Not Available
Research Site
Taipei City, 11217
TaiwanSite Not Available
Research Site
Taoyuan, 333
TaiwanActive - Recruiting
Research Site
Taoyuan District 1667905, 333
TaiwanSite Not Available
Research Site
Duarte, California 91010
United StatesActive - Recruiting
Research Site
Irvine, California 92618
United StatesSite Not Available
Research Site
Duarte 5344147, California 5332921 91010
United StatesSite Not Available
Research Site
Irvine 5359777, California 5332921 92618
United StatesSite Not Available
Research Site
North Haven, Connecticut 06473
United StatesActive - Recruiting
Research Site
North Haven 4839704, Connecticut 4831725 06473
United StatesSite Not Available
Research Site
Washington, District of Columbia 20016
United StatesSite Not Available
Research Site
Washington D.C., District of Columbia 20016
United StatesActive - Recruiting
Research Site
Washington D.C. 4140963, District of Columbia 4138106 20016
United StatesSite Not Available
Research Site
Coral Gables, Florida 33146
United StatesSite Not Available
Research Site
Chicago, Illinois 60637
United StatesActive - Recruiting
Research Site
Chicago 4887398, Illinois 4896861 60637
United StatesSite Not Available
Research Site
Baltimore, Maryland 21231
United StatesActive - Recruiting
Research Site
Baltimore 4347778, Maryland 4361885 21224
United StatesSite Not Available
Research Site
Milford, Massachusetts 01757
United StatesActive - Recruiting
Research Site
Milford 4943958, Massachusetts 6254926 01757
United StatesSite Not Available
Research Site
Mineola, New York 11501
United StatesActive - Recruiting
Research Site
New York, New York 10016
United StatesActive - Recruiting
Research Site
Mineola 5127134, New York 5128638 11501
United StatesSite Not Available
Research Site
New York 5128581, New York 5128638 10029
United StatesSite Not Available
Research Site
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Research Site
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesSite Not Available
Research Site
Providence, Rhode Island 02903
United StatesActive - Recruiting
Research Site
Providence 5224151, Rhode Island 5224323 02903
United StatesSite Not Available
Research Site
Houston, Texas 77030
United StatesActive - Recruiting
Research Site
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
Research Site
Fairfax, Virginia 22031
United StatesActive - Recruiting
Research Site
Fairfax 4758023, Virginia 6254928 22031
United StatesSite Not Available

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