Phase
Condition
Non-small Cell Lung Cancer
Treatment
Osimertinib
Datopotamab Deruxtecan
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age
Participant must be ≥ 18 years; Participant from Japan must be ≥ 20 years, at thetime of signing the ICF. Type of Participant and Disease Characteristics
Histologically or cytologically documented nonsquamous NSCLC.
Stage IIIB or IIIC or Stage IV metastatic NSCLC or recurrent NSCLC (based on theAmerican Joint Committee on Cancer Edition 8) not amenable to curative surgery ordefinitive chemoradiation at the time of randomisation.
Participants must not have received prior EGFR TKIs or other systemic therapy forStage IIIB, IIIC or IV NSCLC.
The tumour harbors 1 of the 2 common EGFR mutations known to be associated withEGFR-TKI sensitivity (Ex19del or L858R), either alone or in combination with otherEGFR mutations.
For participants enrolled in randomisation period, mandatory provision of anunstained, archival tumour tissue sample in a quantity sufficient to allow forcentral confirmation of the EGFR mutation status.
WHO performance status of 0 or 1.
At least one lesion not previously irradiated that qualifies as a RECIST 1.1 TL atbaseline and can be accurately measured at baseline as ≥10 mm in the longestdiameter (except lymph nodes, which must have short axis ≥15 mm) with CT or MRI andis suitable for accurate repeated measurements.
Adequate bone marrow reserve and organ function within 7 days before the first doseof study intervention . Sex and Contraceptive/Barrier Requirements
Male and female Contraceptive use by males or females should be consistent withlocal regulations regarding the methods of contraception for those participating inclinical studies. Other Inclusion Criteria
All races, gender and ethnic groups are eligible for this study.
Exclusion
Exclusion Criteria:
Medical Conditions
As judged by the investigator, any evidence of diseases (such as severe oruncontrolled systemic diseases, including active bleeding diseases, psychiatricillness/social situations), history of allogenic organ transplant, and/or substanceabuse which, in the investigator's opinion, makes it undesirable for the participantto participate in the study or that would jeopardise compliance with the protocol.
Refractory nausea and vomiting, chronic gastrointestinal disease, inability toswallow the formulated product, or previous significant bowel resection that wouldpreclude adequate absorption, distribution, metabolism, or excretion of osimertinib.
History of another primary malignancy.
Spinal cord compression and unstable brain metastases.
Clinically significant corneal disease.
Has active or uncontrolled hepatitis B or C virus infection.
Known HIV infection that is not well controlled.
Uncontrolled infection requiring i.v. antibiotics, antivirals or antifungals;suspected infections (eg, prodromal symptoms); or inability to rule out infections (participants with localised fungal infections of skin or nails are eligible).
Resting ECG with clinically abnormal findings.
Uncontrolled or significant cardiac disease.
Past medical history of ILD, drug-induced ILD, radiation pneumonitis which requiredsteroid treatment, or any evidence of clinically active ILD.
Has severe pulmonary function compromise. Prior/Concomitant Therapy
Prior exposure to any agent including an ADC containing a chemotherapeutic agenttargeting topoisomerase I, TROP2-targeted therapy. Prior/Concurrent Clinical Study Experience
Participants with a known history of severe hypersensitivity reactions to eitherDato-DXd and osimertinib or any excipients of Dato DXd and osimertinib or drugs witha similar chemical structure or class to DXd and osimertinib.
Study Design
Study Description
Connect with a study center
Research Site
Clayton, 3168
AustraliaActive - Recruiting
Research Site
Kogarah, 2217
AustraliaActive - Recruiting
Research Site
South Brisbane, 4101
AustraliaSite Not Available
Research Site
Westmead, 2145
AustraliaActive - Recruiting
Research Site
Barretos, 14784-400
BrazilActive - Recruiting
Research Site
Natal, 59075-740
BrazilSite Not Available
Research Site
Porto Alegre, 91350-200
BrazilSite Not Available
Research Site
Salvador, 41253-190
BrazilSite Not Available
Research Site
Sao Paulo, 01246-000
BrazilSite Not Available
Research Site
Edmonton, Alberta T6G 1Z2
CanadaSite Not Available
Research Site
Montreal, Quebec H4A 3J1
CanadaSite Not Available
Research Site
Beijing, 100034
ChinaSite Not Available
Research Site
Changchun, 130000
ChinaActive - Recruiting
Research Site
Changsha, 410013
ChinaSite Not Available
Research Site
Chengdu, 610072
ChinaSite Not Available
Research Site
Chongqing, 400030
ChinaActive - Recruiting
Research Site
Guangzhou, 510100
ChinaActive - Recruiting
Research Site
Hangzhou, 310006
ChinaSite Not Available
Research Site
Hankou,Wuhan, 430022
ChinaSite Not Available
Research Site
Harbin, 150049
ChinaSite Not Available
Research Site
Hefei, 230031
ChinaSite Not Available
Research Site
Jinan, 250117
ChinaActive - Recruiting
Research Site
Kunming, 650118
ChinaActive - Recruiting
Research Site
Linhai, 318000
ChinaActive - Recruiting
Research Site
Ningbo, 315010
ChinaActive - Recruiting
Research Site
Shanghai, 200433
ChinaSite Not Available
Research Site
Shenyang, 110004
ChinaSite Not Available
Research Site
Wenzhou, 325000
ChinaActive - Recruiting
Research Site
Wuhan, 430030
ChinaActive - Recruiting
Research Site
Xi'an, 710061
ChinaActive - Recruiting
Research Site
Xuzhou, 221000
ChinaActive - Recruiting
Research Site
Yangzhou, 225001
ChinaActive - Recruiting
Research Site
Zhengzhou, 450008
ChinaActive - Recruiting
Research Site
Zhengzhou City, 450000
ChinaSite Not Available
Research Site
Berlin, 13125
GermanySite Not Available
Research Site
Erfurt, 99089
GermanySite Not Available
Research Site
Frankfurt, 60488
GermanyActive - Recruiting
Research Site
Immenhausen, 34376
GermanyActive - Recruiting
Research Site
Kiel, 24105
GermanySite Not Available
Research Site
Köln, 51109
GermanySite Not Available
Research Site
Mainz, 55131
GermanySite Not Available
Research Site
München, 81925
GermanySite Not Available
Research Site
Hong Kong,
Hong KongSite Not Available
Research Site
Jordan, HKG
Hong KongSite Not Available
Research Site
Lai Chi Kok,
Hong KongSite Not Available
Research Site
Bangalore, 560027
IndiaSite Not Available
Research Site
Delhi, 110085
IndiaSite Not Available
Research Site
Hyderabad, 500032
IndiaSite Not Available
Research Site
Kolkata, 700054
IndiaSite Not Available
Research Site
Mysuru, 570017
IndiaSite Not Available
Research Site
Nashik, 422011
IndiaSite Not Available
Research Site
New Delhi, 100049
IndiaSite Not Available
Research Site
Vadodara, 391760
IndiaSite Not Available
Research Site
Varanasi, 221005
IndiaSuspended
Research Site
Milano, 20141
ItalyActive - Recruiting
Research Site
Monza, 20900
ItalyActive - Recruiting
Research Site
Orbassano, 10043
ItalySite Not Available
Research Site
Padova, 35128
ItalyActive - Recruiting
Research Site
Parma, 43100
ItalySite Not Available
Research Site
Chuo-ku, 104-0045
JapanActive - Recruiting
Research Site
Fukuoka-shi, 812-8582
JapanActive - Recruiting
Research Site
Kashiwa, 277-8577
JapanSite Not Available
Research Site
Koto-ku, 135-8550
JapanActive - Recruiting
Research Site
Niigata-shi, 951-8566
JapanSite Not Available
Research Site
Osaka-shi, 541-8567
JapanSite Not Available
Research Site
Osakasayama-shi, 589-8511
JapanSite Not Available
Research Site
Sendai-shi, 981-0914
JapanActive - Recruiting
Research Site
Wakayama-shi, 641-8510
JapanSite Not Available
Research Site
Yokohama-shi, 241-8515
JapanActive - Recruiting
Research Site
Erie, 16544
Korea, Republic ofSite Not Available
Research Site
Goyang-si, 410-769
Korea, Republic ofSite Not Available
Research Site
Namdong-gu, 21565
Korea, Republic ofActive - Recruiting
Research Site
Seoul, 13620
Korea, Republic ofActive - Recruiting
Research Site
Bystra, 43-360
PolandActive - Recruiting
Research Site
Olsztyn, 10-357
PolandActive - Recruiting
Research Site
Poznań, 60-569
PolandActive - Recruiting
Research Site
Warszawa, 02-781
PolandSite Not Available
Research Site
Rio Piedras, 00935
Puerto RicoSite Not Available
Research Site
Barcelona, 8036
SpainSite Not Available
Research Site
Granada, 18007
SpainSite Not Available
Research Site
La Coruña, 15006
SpainSite Not Available
Research Site
Madrid, 28040
SpainSite Not Available
Research Site
Majadahonda, 28222
SpainSite Not Available
Research Site
Valencia, 46009
SpainSite Not Available
Research Site
Taichung, 40705
TaiwanActive - Recruiting
Research Site
Tainan, 704
TaiwanActive - Recruiting
Research Site
Taipei, 10002
TaiwanActive - Recruiting
Research Site
Taipei City, 106
TaiwanActive - Recruiting
Research Site
Taoyuan, 333
TaiwanActive - Recruiting
Research Site
Bangkok, 10700
ThailandActive - Recruiting
Research Site
Dusit, 10300
ThailandActive - Recruiting
Research Site
Hat Yai, 90110
ThailandActive - Recruiting
Research Site
Mueang Udon Thani, 41000
ThailandActive - Recruiting
Research Site
Adana, 01140
TurkeySite Not Available
Research Site
Adapazarı, 54100
TurkeySite Not Available
Research Site
Ankara, 06530
TurkeySite Not Available
Research Site
Goztepe Istanbul,
TurkeySite Not Available
Research Site
Izmir, 35100
TurkeySite Not Available
Research Site
Küçükçekmece, 34295
TurkeySite Not Available
Research Site
Los Alamitos, California 90720
United StatesSite Not Available
Research Site
Los Angeles, California 90017
United StatesSite Not Available
Research Site
Orange, California 92868
United StatesSite Not Available
Research Site
San Diego, California 92123
United StatesSite Not Available
Research Site
New Haven, Connecticut 06510
United StatesSite Not Available
Research Site
Washington, District of Columbia 20037
United StatesSite Not Available
Research Site
Jacksonville, Florida 32256
United StatesSite Not Available
Research Site
Ocala, Florida 34474
United StatesSite Not Available
Research Site
Honolulu, Hawaii 96819
United StatesSite Not Available
Research Site
North Chicago, Illinois 60064
United StatesSite Not Available
Research Site
Fort Wayne, Indiana 46845
United StatesSite Not Available
Research Site
Bethesda, Maryland 20817
United StatesSite Not Available
Research Site
Detroit, Michigan 48201
United StatesSite Not Available
Research Site
Saint Paul, Minnesota 55102
United StatesSite Not Available
Research Site
Saint Louis, Missouri 63110
United StatesSite Not Available
Research Site
Houston, Texas 77090
United StatesSite Not Available
Research Site
Woodway, Texas 76712
United StatesSite Not Available
Research Site
Fairfax, Virginia 22031
United StatesSite Not Available
Research Site
Fort Belvoir, Virginia 22060
United StatesSite Not Available
Research Site
Seattle, Washington 98104
United StatesSite Not Available
Research Site
Ha noi, 100000
VietnamActive - Recruiting
Research Site
Hanoi, 100000
VietnamActive - Recruiting
Research Site
Ho Chi Minh, 700000
VietnamActive - Recruiting
Research Site
Ho Chi Minh City,
VietnamSite Not Available
Research Site
Vinh, 460000
VietnamActive - Recruiting
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