Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05555732
Registration number
NCT05555732
Ethics application status
Date submitted
22/09/2022
Date registered
27/09/2022
Date last updated
31/05/2024
Titles & IDs
Public title
Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07)
Query!
Scientific title
A Randomized Phase 3 Study of Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in Subjects With No Prior Therapy for Advanced or Metastatic PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung07)
Query!
Secondary ID [1]
0
0
2022-500802-16-00
Query!
Secondary ID [2]
0
0
DS1062-A-U303
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Metastatic Non Small Cell Lung Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Lung - Mesothelioma
Query!
Cancer
0
0
0
0
Query!
Lung - Non small cell
Query!
Cancer
0
0
0
0
Query!
Lung - Small cell
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Datopotamab Deruxtecan
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Carboplatin
Treatment: Drugs - Cisplatin
Experimental: Dato-DXd + Pembrolizumab + Platinum Chemotherapy - Participants will be randomized to receive 6.0mg/kg Dato-DXd plus 200 mg pembrolizumab plus platinum chemotherapy (cisplatin 75 mg/m^2 or carboplatin area under the curve [AUC) 5]).
Experimental: Dato-DXd + Pembrolizumab - Participants will be randomized to receive 6.0mg/kg Dato-DXd plus 200 mg pembrolizumab.
Active Comparator: Pembrolizumab + Pemetrexed + Platinum Chemotherapy - Participants will be randomized to receive 200 mg pembrolizumab plus 500 mg/m^2 pemetrexed plus platinum chemotherapy (cisplatin 75 mg/m^2 or carboplatin area under the curve [AUC) 5]).
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.
Treatment: Drugs: Pemetrexed
Pemetrexed will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.
Treatment: Drugs: Carboplatin
Carboplatin will be administered an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.
Treatment: Drugs: Cisplatin
Cisplatin will be administered an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Progression-free Survival Based on Blinded Independent Central Review in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
Query!
Assessment method [1]
0
0
Progression-free Survival (PFS) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1.
Query!
Timepoint [1]
0
0
From randomization until disease progression or death (whichever occurs first), up to approximately 29 months
Query!
Primary outcome [2]
0
0
Overall Survival in Participants in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
Query!
Assessment method [2]
0
0
Overall Survival (OS) is defined as the time from randomization to death due to any cause.
Query!
Timepoint [2]
0
0
From randomization until disease progression or death (whichever occurs first), up to approximately 57 months
Query!
Secondary outcome [1]
0
0
Objective Response Rate by Blinded Independent Central Review in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
Query!
Assessment method [1]
0
0
Objective Response Rate (ORR) is defined as the proportion of participants who achieved a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), assessed by BICR per RECIST Version 1.1.
Query!
Timepoint [1]
0
0
From randomization until disease progression or death (whichever occurs first), up to approximately 29 months
Query!
Secondary outcome [2]
0
0
Progression-free Survival by Investigator in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
Query!
Assessment method [2]
0
0
Progression-free Survival (PFS) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by the Investigator per RECIST Version 1.1.
Query!
Timepoint [2]
0
0
From randomization until disease progression or death (whichever occurs first), up to approximately 29 months
Query!
Secondary outcome [3]
0
0
Objective Response Rate by Investigator in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
Query!
Assessment method [3]
0
0
Objective Response Rate (ORR) is defined as the proportion of participants who achieved a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), assessed by the Investigator per RECIST Version 1.1.
Query!
Timepoint [3]
0
0
From randomization until disease progression or death (whichever occurs first), up to approximately 29 months
Query!
Secondary outcome [4]
0
0
Duration of Response by BICR and Investigator in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
Query!
Assessment method [4]
0
0
Duration of Response (DoR) is defined as the time from the date of the first documentation of objective response (confirmed CR or confirmed PR) to the date of the first radiographic disease progression or death due to any cause, whichever occurs first, assessed by BICR and by the Investigator per RECIST Version 1.1.
Query!
Timepoint [4]
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 29 months
Query!
Secondary outcome [5]
0
0
Time to Response by BICR and Investigator in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
Query!
Assessment method [5]
0
0
Time to Response (TTR) is defined as the time from randomization to the date of the first documentation of objective response (confirmed CR or confirmed PR) in responding participants, assessed by BICR and by the Investigator per RECIST Version 1.1.
Query!
Timepoint [5]
0
0
From randomization to date of first objective response (CR or PR), up to approximately 29 months
Query!
Secondary outcome [6]
0
0
Disease Control Rate by BICR and Investigator in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
Query!
Assessment method [6]
0
0
Disease Control Rate (DCR) is defined as the proportion of participants who achieved a BOR of confirmed CR, confirmed PR, or stable disease (SD), assessed by BICR and by the Investigator per RECIST Version 1.1.
Query!
Timepoint [6]
0
0
From randomization until disease progression or death (whichever occurs first), up to approximately 29 months
Query!
Secondary outcome [7]
0
0
Progression-free Survival 2 in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
Query!
Assessment method [7]
0
0
Progression-free Survival 2 (PFS2) is defined as the time from randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed by local standard clinical practice
Query!
Timepoint [7]
0
0
From randomization until disease progression or death (whichever occurs first), up to approximately 57 months
Query!
Secondary outcome [8]
0
0
Time to Deterioration in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
Query!
Assessment method [8]
0
0
Time to Deterioration (TTD) is defined as the time from randomization to first onset of a =10-point increase in cough, chest pain, or dyspnea, confirmed by a second adjacent =10-point increase from randomization in the same symptom, or confirmed by death within 21 days of a =10-point increase from randomization, assessed the European Organization for Research and Treatment of Cancer Lung cancer module (EORTC-QLQ-LC13).
Query!
Timepoint [8]
0
0
From randomization until disease progression or death (whichever occurs first), up to approximately 57 months
Query!
Secondary outcome [9]
0
0
Number of Participants With Treatment-emergent Adverse Events (TEAE) in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
Query!
Assessment method [9]
0
0
A TEAE is defined as an AE with a start or worsening date on or after the start date of study treatment until 37 days after the end date of study treatment.
Query!
Timepoint [9]
0
0
Up to 57 months
Query!
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
Query!
Assessment method [10]
0
0
The immunogenicity of Dato-DXd in combination with pembrolizumab will be assessed.
Query!
Timepoint [10]
0
0
Baseline and up to 57 months
Query!
Eligibility
Key inclusion criteria
- Sign and date the Main Informed Consent Form (ICF), prior to the start of any study-
specific qualification procedures.
- Adults =18 at the time the Main ICF is signed.
- Has tumor with PD-L1 TPS <50% as determined by PD-L1 IHC 22C3 pharmDx assay by central
testing.
- Has provided a formalin-fixed tumor tissue sample for the measurement of TROP2 protein
expression and for the assessment of other exploratory biomarkers.
- Has not been treated with systemic anticancer therapy for advanced or metastatic
non-squamous NSCLC.
- Has measurable disease based on local imaging assessment using RECIST v1.1.
- Histologically documented NSCLC that meets all of the following criteria:
- 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).
- 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.
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at
screening.
- Has an adequate treatment washout period before Cycle 1 Day 1.
- Is willing and able to participate in the collection of patient-reported outcomes
(PRO) data.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Has received prior systemic treatment for advanced/metastatic NSCLC.
- Has received prior treatment with any of the following, including in the
adjuvant/neoadjuvant (for NSCLC) setting:
- Any agent, including an antibody-drug conjugate, containing a chemotherapeutic
agent targeting topoisomerase I.
- TROP2-targeted therapy.
- 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).
- Any other immune checkpoint inhibitors.
- Has received a live vaccine or live-attenuated vaccine 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.
- Has spinal cord compression or clinically active untreated central nervous system
(CNS) metastases and/or carcinomatous meningitis.
- Uncontrolled or significant cardiovascular disease, including:
- Mean QT interval corrected for heart rate using Fridericia's formula (QTcF)
interval >470 msec regardless of sex.
- Myocardial infarction within 6 months prior to randomization.
- Uncontrolled angina pectoris within 6 months prior to randomization.
- LVEF <50% by ECHO or MUGA scan within 28 days before randomization.
- New York Heart Association Class 2 to 4 congestive heart failure (CHF) at
screening.
- Uncontrolled hypertension within 28 days before randomization.
- Clinically severe pulmonary compromise resulting from intercurrent pulmonary
illnesses.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
- History of another primary malignancy (beyond NSCLC) except for:
- 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.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence
of disease.
- Adequately treated carcinoma in situ without evidence of disease.
- Participants with a history of prostate cancer (tumor/node/metastasis stage) of
Stage =T2cN0M0 without biochemical recurrence or progression.
- Has a history of severe hypersensitivity reactions to either the drugs or inactive
ingredients of Dato-DXd, pembrolizumab, carboplatin, cisplatin or pemetrexed.
- Has a history of severe hypersensitivity reactions to other monoclonal antibodies.
- Has known human immunodeficiency virus (HIV) infection that is not well controlled.
- Has active or uncontrolled hepatitis B or C infection.
- Female who is pregnant or breastfeeding or intends to become pregnant.
- Any other medical conditions, including cardiac disease or psychological disorders,
and/or substance abuse.
- Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that
required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis
cannot be ruled out by imaging at screening.
- Has active, known, or suspected autoimmune disease.
- Has clinically significant corneal disease.
- Has had an allogeneic tissue/solid organ transplantation.
- Has received prior radiotherapy =4 weeks of start of study intervention or more than
30 Gy to the lung within 6 months of Cycle 1 Day 1.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
11/01/2023
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/08/2027
Query!
Actual
Query!
Sample size
Target
975
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
CRSA/ St Andrews Hospital - Adelaide
Query!
Recruitment hospital [2]
0
0
Flinders Medical Centre (Fmc) - Bedford Park
Query!
Recruitment hospital [3]
0
0
PSEHOG (Peninsula and South Eastern Haematology and Oncology Group) - Frankston
Query!
Recruitment hospital [4]
0
0
Southern Medical Day Care Centre - Wollongong
Query!
Recruitment hospital [5]
0
0
Princess Alexandra Hospital - Woolloongabba
Query!
Recruitment postcode(s) [1]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [2]
0
0
5042 - Bedford Park
Query!
Recruitment postcode(s) [3]
0
0
3199 - Frankston
Query!
Recruitment postcode(s) [4]
0
0
2500 - Wollongong
Query!
Recruitment postcode(s) [5]
0
0
QLD 4102 - Woolloongabba
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Illinois
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Maryland
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Massachusetts
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
New Jersey
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
New York
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Texas
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Utah
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Washington
Query!
Country [15]
0
0
Argentina
Query!
State/province [15]
0
0
Ciudad Autonoma de Buenos Aire
Query!
Country [16]
0
0
Argentina
Query!
State/province [16]
0
0
Mar del Plata
Query!
Country [17]
0
0
Argentina
Query!
State/province [17]
0
0
Pergamino
Query!
Country [18]
0
0
Argentina
Query!
State/province [18]
0
0
Rosario
Query!
Country [19]
0
0
Argentina
Query!
State/province [19]
0
0
San Juan
Query!
Country [20]
0
0
Argentina
Query!
State/province [20]
0
0
Viedma
Query!
Country [21]
0
0
Austria
Query!
State/province [21]
0
0
Feldkirch
Query!
Country [22]
0
0
Austria
Query!
State/province [22]
0
0
Klagenfurt
Query!
Country [23]
0
0
Austria
Query!
State/province [23]
0
0
Vienna
Query!
Country [24]
0
0
Belgium
Query!
State/province [24]
0
0
Gent
Query!
Country [25]
0
0
Belgium
Query!
State/province [25]
0
0
Sint-Niklaas
Query!
Country [26]
0
0
Brazil
Query!
State/province [26]
0
0
Belo Horizonte
Query!
Country [27]
0
0
Brazil
Query!
State/province [27]
0
0
Caxias do Sul
Query!
Country [28]
0
0
Brazil
Query!
State/province [28]
0
0
Curitiba
Query!
Country [29]
0
0
Brazil
Query!
State/province [29]
0
0
Ijui
Query!
Country [30]
0
0
Brazil
Query!
State/province [30]
0
0
ItajaA-
Query!
Country [31]
0
0
Brazil
Query!
State/province [31]
0
0
Pelotas
Query!
Country [32]
0
0
Brazil
Query!
State/province [32]
0
0
Porto Alegre
Query!
Country [33]
0
0
Brazil
Query!
State/province [33]
0
0
Rio de Janeiro
Query!
Country [34]
0
0
Brazil
Query!
State/province [34]
0
0
Santo Andre
Query!
Country [35]
0
0
Brazil
Query!
State/province [35]
0
0
Sao Paulo
Query!
Country [36]
0
0
Brazil
Query!
State/province [36]
0
0
Taubate
Query!
Country [37]
0
0
Canada
Query!
State/province [37]
0
0
Quebec City
Query!
Country [38]
0
0
Chile
Query!
State/province [38]
0
0
Santiago de Chile
Query!
Country [39]
0
0
Chile
Query!
State/province [39]
0
0
Santiago
Query!
Country [40]
0
0
Chile
Query!
State/province [40]
0
0
ViAaa Del Mar
Query!
Country [41]
0
0
China
Query!
State/province [41]
0
0
Beijing Sheng
Query!
Country [42]
0
0
China
Query!
State/province [42]
0
0
Beijing
Query!
Country [43]
0
0
China
Query!
State/province [43]
0
0
Cangzhou
Query!
Country [44]
0
0
China
Query!
State/province [44]
0
0
Changchun
Query!
Country [45]
0
0
China
Query!
State/province [45]
0
0
Changsha
Query!
Country [46]
0
0
China
Query!
State/province [46]
0
0
Chengdu
Query!
Country [47]
0
0
China
Query!
State/province [47]
0
0
Chongqing
Query!
Country [48]
0
0
China
Query!
State/province [48]
0
0
Fuzhou
Query!
Country [49]
0
0
China
Query!
State/province [49]
0
0
Guangzhou
Query!
Country [50]
0
0
China
Query!
State/province [50]
0
0
Hangzhou
Query!
Country [51]
0
0
China
Query!
State/province [51]
0
0
Harbin
Query!
Country [52]
0
0
China
Query!
State/province [52]
0
0
Hefei
Query!
Country [53]
0
0
China
Query!
State/province [53]
0
0
Hohhot
Query!
Country [54]
0
0
China
Query!
State/province [54]
0
0
Jiamusi
Query!
Country [55]
0
0
China
Query!
State/province [55]
0
0
Linyi
Query!
Country [56]
0
0
China
Query!
State/province [56]
0
0
Nanchang
Query!
Country [57]
0
0
China
Query!
State/province [57]
0
0
Nanjing
Query!
Country [58]
0
0
China
Query!
State/province [58]
0
0
Shanghai
Query!
Country [59]
0
0
China
Query!
State/province [59]
0
0
Shenyang
Query!
Country [60]
0
0
China
Query!
State/province [60]
0
0
Wuhan
Query!
Country [61]
0
0
China
Query!
State/province [61]
0
0
Xi'an
Query!
Country [62]
0
0
China
Query!
State/province [62]
0
0
Xianyang
Query!
Country [63]
0
0
China
Query!
State/province [63]
0
0
Zhengzhou
Query!
Country [64]
0
0
China
Query!
State/province [64]
0
0
Ürümqi
Query!
Country [65]
0
0
France
Query!
State/province [65]
0
0
Bordeaux
Query!
Country [66]
0
0
France
Query!
State/province [66]
0
0
France
Query!
Country [67]
0
0
France
Query!
State/province [67]
0
0
Lyon
Query!
Country [68]
0
0
France
Query!
State/province [68]
0
0
Marseille Cedex 20
Query!
Country [69]
0
0
France
Query!
State/province [69]
0
0
Montpellier Cedex 5
Query!
Country [70]
0
0
France
Query!
State/province [70]
0
0
Nantes
Query!
Country [71]
0
0
France
Query!
State/province [71]
0
0
Paris
Query!
Country [72]
0
0
France
Query!
State/province [72]
0
0
Suresnes
Query!
Country [73]
0
0
Germany
Query!
State/province [73]
0
0
Berlin
Query!
Country [74]
0
0
Germany
Query!
State/province [74]
0
0
Chemnitz
Query!
Country [75]
0
0
Germany
Query!
State/province [75]
0
0
Essen
Query!
Country [76]
0
0
Germany
Query!
State/province [76]
0
0
Esslingen
Query!
Country [77]
0
0
Germany
Query!
State/province [77]
0
0
Muenster
Query!
Country [78]
0
0
Germany
Query!
State/province [78]
0
0
Munich
Query!
Country [79]
0
0
Greece
Query!
State/province [79]
0
0
Athens
Query!
Country [80]
0
0
Greece
Query!
State/province [80]
0
0
Heraklion
Query!
Country [81]
0
0
Greece
Query!
State/province [81]
0
0
Ioannina
Query!
Country [82]
0
0
Greece
Query!
State/province [82]
0
0
Neo Faliro
Query!
Country [83]
0
0
Greece
Query!
State/province [83]
0
0
Thessalonki
Query!
Country [84]
0
0
Hong Kong
Query!
State/province [84]
0
0
Hong Kong
Query!
Country [85]
0
0
Hong Kong
Query!
State/province [85]
0
0
Pok Fu Lam
Query!
Country [86]
0
0
Hungary
Query!
State/province [86]
0
0
Budapest
Query!
Country [87]
0
0
Hungary
Query!
State/province [87]
0
0
Farkasgyepu
Query!
Country [88]
0
0
Hungary
Query!
State/province [88]
0
0
KecskemAÅ t
Query!
Country [89]
0
0
Hungary
Query!
State/province [89]
0
0
Szekesfehervar
Query!
Country [90]
0
0
Hungary
Query!
State/province [90]
0
0
Szolnok
Query!
Country [91]
0
0
Italy
Query!
State/province [91]
0
0
Candiolo
Query!
Country [92]
0
0
Italy
Query!
State/province [92]
0
0
Orbassano
Query!
Country [93]
0
0
Italy
Query!
State/province [93]
0
0
Udine
Query!
Country [94]
0
0
Italy
Query!
State/province [94]
0
0
Varese
Query!
Country [95]
0
0
Italy
Query!
State/province [95]
0
0
Verona
Query!
Country [96]
0
0
Japan
Query!
State/province [96]
0
0
Azuma
Query!
Country [97]
0
0
Japan
Query!
State/province [97]
0
0
Bunkyo-Ku
Query!
Country [98]
0
0
Japan
Query!
State/province [98]
0
0
Fukuoka
Query!
Country [99]
0
0
Japan
Query!
State/province [99]
0
0
Hataji
Query!
Country [100]
0
0
Japan
Query!
State/province [100]
0
0
Hirakata
Query!
Country [101]
0
0
Japan
Query!
State/province [101]
0
0
Iwakuni
Query!
Country [102]
0
0
Japan
Query!
State/province [102]
0
0
Kanazawa-shi
Query!
Country [103]
0
0
Japan
Query!
State/province [103]
0
0
Kanemaru
Query!
Country [104]
0
0
Japan
Query!
State/province [104]
0
0
Kofu
Query!
Country [105]
0
0
Japan
Query!
State/province [105]
0
0
Koto
Query!
Country [106]
0
0
Japan
Query!
State/province [106]
0
0
Kozuki
Query!
Country [107]
0
0
Japan
Query!
State/province [107]
0
0
Kumamoto
Query!
Country [108]
0
0
Japan
Query!
State/province [108]
0
0
Kyoto
Query!
Country [109]
0
0
Japan
Query!
State/province [109]
0
0
Matsusaka
Query!
Country [110]
0
0
Japan
Query!
State/province [110]
0
0
Niigata
Query!
Country [111]
0
0
Japan
Query!
State/province [111]
0
0
Nishinomiya
Query!
Country [112]
0
0
Japan
Query!
State/province [112]
0
0
Okamato
Query!
Country [113]
0
0
Japan
Query!
State/province [113]
0
0
Sapporo-shi
Query!
Country [114]
0
0
Japan
Query!
State/province [114]
0
0
Sendai
Query!
Country [115]
0
0
Japan
Query!
State/province [115]
0
0
Shimotsuga-gun
Query!
Country [116]
0
0
Japan
Query!
State/province [116]
0
0
Toyonaka-shi
Query!
Country [117]
0
0
Japan
Query!
State/province [117]
0
0
Ube-shi
Query!
Country [118]
0
0
Japan
Query!
State/province [118]
0
0
Yokohama
Query!
Country [119]
0
0
Korea, Republic of
Query!
State/province [119]
0
0
Cheongjusi
Query!
Country [120]
0
0
Korea, Republic of
Query!
State/province [120]
0
0
Daegu
Query!
Country [121]
0
0
Korea, Republic of
Query!
State/province [121]
0
0
Gangnam-Gu
Query!
Country [122]
0
0
Korea, Republic of
Query!
State/province [122]
0
0
Goyang-si
Query!
Country [123]
0
0
Korea, Republic of
Query!
State/province [123]
0
0
Jinju-si Gyeongsangnam-do
Query!
Country [124]
0
0
Korea, Republic of
Query!
State/province [124]
0
0
Seongnam-si
Query!
Country [125]
0
0
Korea, Republic of
Query!
State/province [125]
0
0
Seoul
Query!
Country [126]
0
0
Netherlands
Query!
State/province [126]
0
0
Breda
Query!
Country [127]
0
0
Netherlands
Query!
State/province [127]
0
0
Leiden
Query!
Country [128]
0
0
Netherlands
Query!
State/province [128]
0
0
s-Hertogenbosch
Query!
Country [129]
0
0
Poland
Query!
State/province [129]
0
0
Lodz
Query!
Country [130]
0
0
Poland
Query!
State/province [130]
0
0
Poznan
Query!
Country [131]
0
0
Romania
Query!
State/province [131]
0
0
Cluj- Napoca
Query!
Country [132]
0
0
Romania
Query!
State/province [132]
0
0
Craiova
Query!
Country [133]
0
0
Romania
Query!
State/province [133]
0
0
Timisoara
Query!
Country [134]
0
0
Spain
Query!
State/province [134]
0
0
Barcelona
Query!
Country [135]
0
0
Spain
Query!
State/province [135]
0
0
Lleida
Query!
Country [136]
0
0
Spain
Query!
State/province [136]
0
0
Madrid
Query!
Country [137]
0
0
Spain
Query!
State/province [137]
0
0
Malaga
Query!
Country [138]
0
0
Spain
Query!
State/province [138]
0
0
Ourense
Query!
Country [139]
0
0
Spain
Query!
State/province [139]
0
0
Sevilla
Query!
Country [140]
0
0
Spain
Query!
State/province [140]
0
0
Valenica
Query!
Country [141]
0
0
Spain
Query!
State/province [141]
0
0
Zaragoza
Query!
Country [142]
0
0
Switzerland
Query!
State/province [142]
0
0
Liestal
Query!
Country [143]
0
0
Switzerland
Query!
State/province [143]
0
0
St. Gallen
Query!
Country [144]
0
0
Switzerland
Query!
State/province [144]
0
0
Thun
Query!
Country [145]
0
0
Taiwan
Query!
State/province [145]
0
0
Hsia
Query!
Country [146]
0
0
Taiwan
Query!
State/province [146]
0
0
Taipei
Query!
Country [147]
0
0
Thailand
Query!
State/province [147]
0
0
Bangkok
Query!
Country [148]
0
0
Thailand
Query!
State/province [148]
0
0
Chiang Mai
Query!
Country [149]
0
0
Thailand
Query!
State/province [149]
0
0
Hat Yai
Query!
Country [150]
0
0
Thailand
Query!
State/province [150]
0
0
Mueang Nonthaburi
Query!
Country [151]
0
0
Turkey
Query!
State/province [151]
0
0
Adana
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Daiichi Sankyo
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/Industry
Query!
Name [1]
0
0
AstraZeneca
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Commercial sector/Industry
Query!
Name [2]
0
0
Merck Sharp & Dohme LLC
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd)
in combination with pembrolizumab versus pembrolizumab in combination with pemetrexed and
platinum chemotherapy in participants with no prior therapy for advanced or metastatic
non-squamous non-small cell lung cancer (NSCLC).
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT05555732
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Global Clinical Leader
Query!
Address
0
0
Daiichi Sankyo
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
(US Sites) Daiichi Sankyo Contact for Clinical Trial Information
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
908-992-6400
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05555732
Download to PDF