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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05215340




Registration number
NCT05215340
Ethics application status
Date submitted
18/01/2022
Date registered
31/01/2022
Date last updated
21/05/2024

Titles & IDs
Public title
Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations
Scientific title
A Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in Treatment-naïve Subjects With Advanced or Metastatic PD-L1 High (TPS =50%) Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung08)
Secondary ID [1] 0 0
2021-002555-10
Secondary ID [2] 0 0
DS1062-A-U304
Universal Trial Number (UTN)
Trial acronym
TROPION-Lung08
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Non Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Datopotamab Deruxtecan
Treatment: Drugs - Pembrolizumab

Experimental: Pembrolizumab + Datopotamab Deruxtecan (Dato-DXd) - Participants will be randomized to receive 200 mg pembrolizumab followed by 6.0mg/kg Dato-DXd.

Active Comparator: Pembrolizumb - Participants will be randomized to receive 200 mg pembrolizumab.


Treatment: Drugs: Datopotamab Deruxtecan
Dato-DXd will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.

Treatment: Drugs: Pembrolizumab
Pembrolizumab will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival Based on Blinded Independent Central Review in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Timepoint [1] 0 0
From randomization until disease progression or death (whichever occurs first), up to approximately 32 months
Primary outcome [2] 0 0
Overall Survival in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Timepoint [2] 0 0
From randomization until date of death due to any cause, up to approximately 53 months
Secondary outcome [1] 0 0
Objective Response Rate by Blinded Independent Central Review in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Timepoint [1] 0 0
From randomization until disease progression or death (whichever occurs first), up to approximately 32 months
Secondary outcome [2] 0 0
Progression-free Survival by Investigator in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Timepoint [2] 0 0
From randomization until disease progression or death (whichever occurs first), up to approximately 32 months
Secondary outcome [3] 0 0
Progression-free Survival 2 in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Timepoint [3] 0 0
From randomization until disease progression or death (whichever occurs first), up to approximately 53 months
Secondary outcome [4] 0 0
Objective Response Rate by Investigator in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Timepoint [4] 0 0
From randomization until disease progression or death (whichever occurs first), up to approximately 32 months
Secondary outcome [5] 0 0
Duration of Response by BICR and Investigator in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Timepoint [5] 0 0
From date of first objective response (CR or PR) to date of first radiographic disease progression or death due to any cause (whichever occurs first), up to approximately 32 months
Secondary outcome [6] 0 0
Time to Response by BICR and Investigator in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Timepoint [6] 0 0
From randomization to date of first objective response (CR or PR), up to approximately 32 months
Secondary outcome [7] 0 0
Disease Control Rate by BICR and Investigator in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Timepoint [7] 0 0
From randomization until disease progression or death (whichever occurs first), up to approximately 32 months
Secondary outcome [8] 0 0
Time to Deterioration in Participants Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Timepoint [8] 0 0
From randomization until disease progression or death (whichever occurs first), up to approximately 53 months
Secondary outcome [9] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAE) Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Timepoint [9] 0 0
Up to 53 months
Secondary outcome [10] 0 0
Proportion of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) and Proportion of Participants Who Have Treatment-emergent ADA
Timepoint [10] 0 0
Baseline and up to 53 months

Eligibility
Key inclusion criteria
Participants eligible for inclusion in the study must meet all inclusion criteria within 28
days of randomization into the study.

- Sign and date the Tissue Screening and Main Informed Consent Forms, prior to the start
of any study-specific qualification procedures.

- Adults =18 years or the minimum legal adult age (whichever is greater) at the time of
informed consent.

- Histologically documented NSCLC that meets all of the following criteria:

1. Stage IIIB or IIIC disease and not candidates for surgical resection or
definitive chemoradiation, or Stage IV NSCLC disease at the time of randomization
(based on the American Joint Committee on Cancer, Eighth Edition). Participants
with early-stage NSCLC who have relapsed should be restaged during screening to
ensure their eligibility for the study.

2. Documented negative test results for epidermal growth factor receptor (EGFR),
lymphoma kinase (ALK), and proto-oncogene1 (ROS1) actionable genomic alterations
based on analysis of tumor tissue.

3. No known actionable genomic alterations in neurotrophic tyrosine receptor kinase
(NTRK), proto-oncogene B-raf (BRAF), rearranged during transfection (RET),
mesenchymal-epithelial transition factor (MET), or other actionable driver
kinases with locally approved therapies.

- Has provided a formalin-fixed tumor tissue sample for the measurement of trophoblast
cell surface protein 2 (TROP2) protein expression and for the assessment of other
exploratory biomarkers.

- Tumor has high programmed death receptor-1 (PD-L1) expression (TPS =50%) as determined
by PD-L1 immunohistochemistry (IHC) 22C3 pharmDx assay by central testing (minimum of
6 slides).

- Has an adequate treatment washout period before Cycle 1 Day 1.

- Measurable disease based on local imaging assessment using RECIST Version 1.1.

- Has left ventricular ejection fraction (LVEF) =50% by either an echocardiogram (ECHO)
or multigated acquisition scan (MUGA) within 28 days before randomization.

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at
screening.

- Has a life expectancy of at least 3 months.

- Adequate bone marrow function within 7 days before randomization.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Has received prior systemic treatment for advanced or metastatic NSCLC.

- Has received prior treatment for NSCLC with any of the following, including in the
adjuvant/neoadjuvant setting:

1. Any agent, including an antibody-drug conjugate, containing a chemotherapeutic
agent targeting topoisomerase I.

2. TROP2-targeted therapy.

3. Any anti-programmed death receptor-1 (PD-1), anti-PD-L1, or anti-PD-ligand 2 (L2)
agent or with an agent directed to another stimulatory or co-inhibitory T-cell
receptor (eg, CTLA-4, OX40, CD137).

4. Any other immune checkpoint inhibitors. Participants who received adjuvant or
neoadjuvant therapy OTHER than those listed above, are eligible if the
adjuvant/neoadjuvant therapy was completed at least 6 months prior to the
diagnosis of advanced/metastatic disease.

- Has spinal cord compression or active and untreated central nervous system (CNS)
metastases and/or carcinomatous meningitis. Participants with previously treated brain
metastases may participate provided they are radiologically stable.

- Has received prior radiotherapy =4 weeks of start of study intervention or more than
30 Gy (unit of ionizing radiation dose in the International System of Units) to the
lung within 6 months of Cycle 1 Day 1.

- History of another primary malignancy (beyond NSCLC) except for:

1. Malignancy treated with curative intent and with no known active disease =3 years
before the first dose of study treatment and of low potential risk for
recurrence.

2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence
of disease.

3. Adequately treated carcinoma in situ without evidence of disease.

4. Participants with a history of prostate cancer (tumor/node/metastasis stage) of
Stage =T2cN0M0 without biochemical recurrence or progression and who in the
opinion of the Investigator are not deemed to require active intervention.

- Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis
including radiation pneumonitis that required steroids, has current ILD/pneumonitis,
or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.

- Clinically severe pulmonary compromise, as judged by the investigator, resulting from
intercurrent pulmonary illnesses including, but not limited to, any underlying
pulmonary disorder, or any autoimmune, connective tissue or inflammatory disorders
with pulmonary involvement or prior complete pneumonectomy.

- Uncontrolled or significant cardiovascular disease, including:

1. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF)
interval >470 msec regardless of sex (based on the average of the 12-lead
electrocardiogram determination at screening).

2. Myocardial infarction within 6 months prior to randomization.

3. Uncontrolled angina pectoris within 6 months prior to randomization.

4. LVEF <50% by ECHO or MUGA scan within 28 days before randomization.

5. New York Heart Association Class 2 to 4 congestive heart failure (CHF) at
screening.

6. Uncontrolled hypertension (resting systolic blood pressure >180 mmHg or diastolic
blood pressure >110 mmHg) within 28 days before randomization.

Participants with a history of Class 2 to 4 CHF prior to screening, must have returned to
Class 1 CHF and have LVEF =50% (by either an ECHO or MUGA scan within 28 days before
randomization) in order to be eligible.

- Clinically significant corneal disease.

- Has received a live vaccine or live-attenuated vaccine (messenger ribonucleic acid and
replication-incompetent adenoviral vaccines are not considered attenuated live
vaccines) within 30 days prior to the first dose of study drug. For any participant
receiving an approved severe acute respiratory syndrome coronavirus 2 (SARS-CoV2)
vaccine, please follow the vaccine label and/or local guidance.

- Active, known, or suspected autoimmune disease (has an active autoimmune disease that
has required systemic treatment in the past 2 years).

- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
(in dosage >10 mg daily of prednisone equivalent) or any other form of
immunosuppressive therapy =7 days prior to the first dose of study drug.

- Has known human immunodeficiency virus (HIV) infection that is not well controlled.

- Has an active hepatitis or uncontrolled hepatitis B or active hepatitis C infection.

- Has an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.

- Had an allogeneic tissue/solid organ transplant.

- Has a history of severe hypersensitivity reactions to either the drug or inactive
ingredients (including but not limited to polysorbate 80) of Dato-DXd or
pembrolizumab.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/04/2028
Actual
Sample size
Target
740
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [2] 0 0
Peninsula and South Eastern Haematology and Oncology Group - Mount Waverley
Recruitment hospital [3] 0 0
Chris Obrien Lifehouse - Camperdown
Recruitment hospital [4] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment postcode(s) [2] 0 0
3149 - Mount Waverley
Recruitment postcode(s) [3] 0 0
2050 - Camperdown
Recruitment postcode(s) [4] 0 0
5011 - Woodville South
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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California
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Colorado
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Maryland
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Massachusetts
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New Hampshire
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New York
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Utah
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Washington
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Wisconsin
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Argentina
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Ciudad Autonoma de Buenos Aire
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Argentina
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Argentina
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Pergamino
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Rosario
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Viedma
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Aalst
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Charleroi
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Gent
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Harbin
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Hohhot
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Jiamusi
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Kunming
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Linyi
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Nanchang
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Nanjing
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Neijiang
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Shanghai Shi
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Shanghai
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Shenyang City
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Shenyang
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Tianjin
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China
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Wuhan
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Xi'an
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Xiamen
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Xiangyang
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China
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Ürümqi
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Bordeaux
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Lille
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Lyon
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Montpellier
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Nantes Cedex 2
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Nantes
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Paris
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Poitiers
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Berlin
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Esslingen
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Grosshansdorf
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Germany
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Muenchen
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Greece
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Athens
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Greece
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Ioannina
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Greece
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Neo Faliro
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Greece
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Thessaloniki
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Hong Kong
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Hong Kong
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Hong Kong
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Pok Fu Lam
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Hungary
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Budapest
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Hungary
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Farkasgyepu
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Hungary
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KecskemAŠt
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Hungary
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Szekesfehervar
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Hungary
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Torokbalint
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Italy
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Bari
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Italy
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Chieti
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Italy
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Milano
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Italy
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Naples
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Italy
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Perugia
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Italy
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Rome
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Italy
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Varese
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Japan
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Aomori
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Japan
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Chiba
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Ehime
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Fukuoka
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Ishikawa
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Kanagawa
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Kumamoto
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Mie
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Miyagi
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Japan
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Niigata
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Japan
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Osaka
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Japan
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Saitama
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Tochigi
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Japan
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Tokyo
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Toyko
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Yamaguchi
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Japan
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Kofu-shi
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Japan
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Kyoto-shi
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Japan
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Sapporo
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Korea, Republic of
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Chungbuk
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Gyeongsangnam-do
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Korea, Republic of
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Daegu
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Korea, Republic of
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Goyang-si
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Korea, Republic of
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Seoul
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Korea, Republic of
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Songpa-gu
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Mexico
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Cuauhtémoc
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Mexico
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Guadalajara
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Mexico
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Monterrey
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Mexico
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Oaxaca de Juarez
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Mexico
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San Luis Potosí
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Netherlands
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Gelderland
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Netherlands
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Amsterdam
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Netherlands
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Leiden
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Netherlands
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s-Hertogenbosch
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Poland
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Iodzkie
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Poland
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Pomorskie
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Poland
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Zachodniopomorskie
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Poland
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Bialystok
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Poland
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Lublin
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Portugal
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Lisboa
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Portugal
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Porto
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Romania
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Craiova
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Romania
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Suceava
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Romania
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Timisoara
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Spain
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Barcelona
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Spain
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Lleida
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Ourense
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Spain
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Sevilla
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Spain
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Valencia
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Spain
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Zaragoza
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Switzerland
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Baden
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Switzerland
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Basel
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Switzerland
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Liestal
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Taiwan
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Kaohsiung City
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Taiwan
State/province [158] 0 0
Kaohsiung
Country [159] 0 0
Taiwan
State/province [159] 0 0
Taichung
Country [160] 0 0
Taiwan
State/province [160] 0 0
Tainan
Country [161] 0 0
Taiwan
State/province [161] 0 0
Taipei City
Country [162] 0 0
Taiwan
State/province [162] 0 0
Taipei
Country [163] 0 0
Taiwan
State/province [163] 0 0
Taoyuan
Country [164] 0 0
Thailand
State/province [164] 0 0
Khon Kaen
Country [165] 0 0
Thailand
State/province [165] 0 0
Songkhla
Country [166] 0 0
Thailand
State/province [166] 0 0
Bangkok
Country [167] 0 0
Turkey
State/province [167] 0 0
Adana
Country [168] 0 0
Turkey
State/province [168] 0 0
Bornova-Izmir
Country [169] 0 0
Turkey
State/province [169] 0 0
Istanbul
Country [170] 0 0
Turkey
State/province [170] 0 0
Seyhan /Adana
Country [171] 0 0
United Kingdom
State/province [171] 0 0
Birmingham
Country [172] 0 0
United Kingdom
State/province [172] 0 0
Glasgow
Country [173] 0 0
United Kingdom
State/province [173] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Daiichi Sankyo
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
AstraZeneca
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Merck Sharp & Dohme LLC
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd)
in combination with pembrolizumab versus pembrolizumab alone in participants with advanced or
metastatic non-small cell lung cancer (NSCLC).
Trial website
https://clinicaltrials.gov/ct2/show/NCT05215340
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Leader
Address 0 0
Daiichi Sankyo
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
(US Sites) Daiichi Sankyo Contact for Clinical Trial Information
Address 0 0
Country 0 0
Phone 0 0
908-992-6400
Fax 0 0
Email 0 0
CTRinfo@dsi.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05215340