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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06357533
Registration number
NCT06357533
Ethics application status
Date submitted
5/04/2024
Date registered
10/04/2024
Date last updated
14/06/2024
Titles & IDs
Public title
Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC = 50%) and Without Actionable Genomic Alterations
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Scientific title
A Phase III, Randomised, Open-label, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Pembrolizumab Monotherapy for the First-line Treatment of Participants With Locally-advanced or Metastatic Non-squamous NSCLC With High PD-L1 Expression (TC = 50%) and Without Actionable Genomic Alterations (TROPION-Lung10)
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Secondary ID [1]
0
0
D7632C00001
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Universal Trial Number (UTN)
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Trial acronym
TROPION-Lung10
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Cancer
0
0
0
0
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Lung - Non small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Datopotamab Deruxtecan
Treatment: Drugs - Rilvegostomig
Treatment: Drugs - Pembrolizumab
Experimental: Arm 1: Dato-DXd in Combination With Rilvegostomig - Participants in the Dato-DXd in combination with Rilvegostomig group will receive Dato-DXd plus rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Experimental: Arm 2: Rilvegostomig Monotherapy - Participants in the rilvegostomig monotherapy group will receive rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Active comparator: Arm 3: Pembrolizumab Monotherapy - Participants in the pembrolizumab group will receive pembrolizumab as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Treatment: Drugs: Datopotamab Deruxtecan
Datopotamab Deruxtecan IV (intravenous)
Treatment: Drugs: Rilvegostomig
Rilvegostomig IV (intravenous)
Treatment: Drugs: Pembrolizumab
Pembrolizumab IV (intravenous)
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Intervention code [1]
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0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-Free Survival (PFS) in TROP2 biomarker positive participants.
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Assessment method [1]
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0
PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause.
The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST 1.1 progression, in the following population:
• TROP2 biomarker positive population
The measure of interest is the HR of PFS. PFS by investigator will be reported as a sensitivity analysis.
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Timepoint [1]
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Approximately 4 years
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Primary outcome [2]
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Overall Survival (OS) in TROP2 biomarker positive participants.
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Assessment method [2]
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0
OS is defined as the time from randomisation until the date of death due to any cause.
The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy or receives another anti-cancer therapy, in the following population:
• TROP2 biomarker positive population The measure of interest is the HR of OS.
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Timepoint [2]
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0
Approximately 6 years
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Secondary outcome [1]
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Progression-Free Survival (PFS) in the intent-to-treat (ITT) population.
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Assessment method [1]
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0
PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause.
The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy, receives another anti cancer therapy or clinically progresses prior to RECIST 1.1 progression, in the following population:
• ITT population
The measure of interest is the HR of PFS. PFS by investigator will be reported as a sensitivity analysis.
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Timepoint [1]
0
0
Approximately 4 years
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Secondary outcome [2]
0
0
Overall Survival (OS) in the intent-to-treat (ITT) population.
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Assessment method [2]
0
0
OS is defined as the time from randomisation until the date of death due to any cause.
The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy or receives another anti-cancer therapy, in the following population:
• ITT population The measure of interest is the HR of OS.
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Timepoint [2]
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Approximately 6 years
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Secondary outcome [3]
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Objective Response Rate (ORR)
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Assessment method [3]
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ORR is defined as the proportion of participants who have a CR or PR, as determined by BICR per RECIST 1.1.
The analyses will include all randomised participants, as randomised, with measurable disease at baseline, in the following populations:
* TROP2 biomarker positive population
* ITT population Data obtained from randomisation up until progression, or the last evaluable assessment in the absence of progression, will be included in the assessment of ORR, regardless of whether the participant withdraws from therapy. Participants who go off treatment without a response or progression, receive a subsequent therapy, and then respond will not be included as responders in the ORR.
The measure of interest is the OR of the ORR. ORR by investigator will be reported as a sensitivity analysis.
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Timepoint [3]
0
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Approximately 4 years
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Secondary outcome [4]
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Duration of Response (DoR)
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Assessment method [4]
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DoR is defined as the time from the date of first documented response until date of documented progression per RECIST 1.1, as assessed by BICR and investigator assessment or death due to any cause.
The analyses will include all randomised participants who have a response, as randomised, regardless of whether the participant withdraws from randomised therapy, receives another anti cancer therapy or clinically progresses prior to RECIST 1.1 progression, in the following populations:
* TROP2 biomarker positive population
* ITT population The measure of interest is the median of DoR. DoR by investigator will be reported as a sensitivity analysis.
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Timepoint [4]
0
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Approximately 4 years
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Secondary outcome [5]
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0
Participant-reported lung cancer symptoms of NSCLC in participants treated with Dato-DXd in combination with rilvegostomig relative to pembrolizumab.
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Assessment method [5]
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Time to deterioration in pulmonary symptoms (dyspnoea, cough, and chest pain) as measured by the NSCLC-SAQ.
Time to deterioration in overall lung cancer symptoms as measured by the NSCLC-SAQ.
Time to deterioration is defined as the time from randomisation until the date of deterioration. Deterioration is defined as change from baseline that reaches a clinically meaningful deterioration threshold. The analyses will include all randomised participants, in the following populations:
* TROP2 biomarker positive population
* ITT population The measure of interest is the HR of time to deterioration in pulmonary symptoms and the HR of time to deterioration in overall lung cancer symptoms.
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Timepoint [5]
0
0
Approximately 6 years
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Secondary outcome [6]
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Participant-reported physical functioning in participants treated with Dato DXd in combination with rilvegostomig relative to pembrolizumab.
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Assessment method [6]
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Time to deterioration in physical functioning as measured by PROMIS Physical Function short form 8c.
Time to deterioration is defined as the time from randomisation until the date of deterioration. Deterioration is defined as change from baseline that reaches a clinically meaningful deterioration threshold. The analyses will include all randomised participants, in the following populations:
* TROP2 biomarker positive population
* ITT population The measure of interest is the HR of time to deterioration in physical functioning.
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Timepoint [6]
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Approximately 6 years
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Secondary outcome [7]
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Participant-reported GHS/QoL in participants treated with Dato-DXd in combination with rilvegostomig relative to pembrolizumab.
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Assessment method [7]
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Time to deterioration in GHS/QoL as measured by the GHS/QoL scale from EORTC IL172.
Time to deterioration is defined as time from the date of randomisation to the date of deterioration. Deterioration is defined as change from baseline that reaches a clinically meaningful deterioration threshold. The analysis will include all randomised participants, in the following populations:
* TROP2 biomarker positive population
* ITT population The measure of interest is the HR of time to deterioration in GHS/QoL.
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Timepoint [7]
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Approximately 6 years
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Secondary outcome [8]
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Pharmacokinetics (PK)
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Assessment method [8]
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Concentration of rilvegostomig, Dato-DXd, total anti TROP2 antibody, and MAAA 1181a (payload deruxtecan) in plasma or serum and PK parameters (peak and trough concentrations).
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Timepoint [8]
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Approximately 6 years
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Secondary outcome [9]
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Immunogenicity
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Assessment method [9]
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Presence of ADA for Dato-DXd and rilvegostomig (confirmatory results, titres and neutralising antibodies for confirmed positive samples).
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Timepoint [9]
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Approximately 6 years
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Secondary outcome [10]
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Second Progression-Free Survival (PFS2).
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Assessment method [10]
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PFS2 is defined as the time from randomisation to the earliest of the progression events (following the initial progression), subsequent to first subsequent therapy, or death. Progression event includes radiological (RECIST 1.1) or clinical disease progression.
The date of second progression will be recorded by the investigator in the eCRF and defined according to local standard practice.
The analyses will include all randomised participants, as randomised, regardless of whether the participant withdraws from subsequent therapy and regardless of missed visits, in the following populations:
* TROP2 biomarker positive population
* ITT population The measure of interest is the HR of PFS2.
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Timepoint [10]
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Approximately 6 years
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Eligibility
Key inclusion criteria
* Histologically or cytologically documented non-squamous NSCLC.
* Stage IIIB or IIIC or Stage IV metastatic NSCLC (according to Edition 8 of the AJCC staging manual) not amenable to curative surgery or definitive chemoradiation.
* Absence of sensitising EGFR mutations, and ALK and ROS1 rearrangements, and absence of documented local test result for any other known genomic alteration for which there are locally approved targeted first-line therapies.
* Must provide tumor sample to determine PD-L1 status, TROP2 status and other biomarkers.
* Known tumour PD-L1 expression status defined as TC = 50%
* At least one lesion, not previously irradiated that qualifies as a RECIST 1.1 target lesion at baseline
* ECOG performance status of 0 or 1
* Adequate bone marrow reserve and organ function within 7 days before the first dose of study intervention
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Prior systemic therapy for advanced/metastatic NSCLC.
* Squamous cell histology, or predominantly squamous cell histology NSCLC; mixed small cell lung cancer; NSCLC histology, sarcomatoid variant.
* History of another primary malignancy within 3 years
* Active or prior documented autoimmune or inflammatory disorders (with exceptions)
* Any evidence of severe or uncontrolled systemic diseases, including, but not limited to active bleeding diseases, active infection, active ILD/pneumonitis, cardiac disease.
* Has clinically significant third-space fluid retention (for example pleural effusion) and is not amenable for repeated drainage.
* History of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
* Has severe pulmonary function compromise resulting from intercurrent pulmonary illnesses
* Spinal cord compression, or brain metastases unless participant treated and no longer symptomatic, radiologically stable, and who require no treatment with corticosteroids or anticonvulsants.
* History of leptomeningeal carcinomatosis
* Known clinically significant corneal disease
* Active infection with TB, HBV, HCV, Hepatitis A, or known HIV infection that is not well controlled
* History of active primary immunodeficiency
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/04/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
24/05/2030
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Actual
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Sample size
Target
675
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Clayton
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Recruitment hospital [2]
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Research Site - Melbourne
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Recruitment hospital [3]
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Research Site - South Brisbane
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment postcode(s) [2]
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3000 - Melbourne
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Recruitment postcode(s) [3]
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QL 4101 - South Brisbane
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Recruitment outside Australia
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Mississippi
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Utsunomiya-shi
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Korea, Republic of
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Changwon
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Incheon
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Seoul
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Suwon
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Alicante
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Spain
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Barcelona
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Spain
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Jerez de la Frontera
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Spain
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Reus,Tarragona
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Spain
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Salamanca
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Taiwan
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Kaohsiung
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Taiwan
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New Taipei
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Turkey
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Adapazari
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Turkey
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Turkey
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Antalya
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Turkey
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Diyarbakir
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Turkey
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Istanbul
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United Kingdom
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Inverness
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United Kingdom
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London
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Truro
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Funding & Sponsors
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Commercial sector/industry
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Name
AstraZeneca
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Summary
Brief summary
The purpose of this study is to evaluate efficacy and safety of Dato-DXd in combination with rilvegostomig or rilvegostomig monotherapy compared with pembrolizumab monotherapy as a first line therapy in participants with locally advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC = 50%) and without actionable genomic alterations.
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Trial website
https://clinicaltrials.gov/study/NCT06357533
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Public notes
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Contacts
Principal investigator
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Suresh S. Ramalingam, MD
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Emory University, Atlanta, Georgia, United States of America.
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AstraZeneca Clinical Study Information Center
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Phone
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1-877-240-9479
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
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Results not provided in
https://clinicaltrials.gov/study/NCT06357533
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