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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

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
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)
Secondary ID [1] 0 0
2023-505077-32-00
Secondary ID [2] 0 0
D7632C00001
Universal Trial Number (UTN)
Trial acronym
TROPION-Lung10
Linked study record

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

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

Experimental: Arm 1: Datopotamab Deruxtecan in Combination With Rilvegostomig - Participants in the Datopotamab Deruxtecan (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)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) in TROP2 biomarker positive participants.
Assessment method [1] 0 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.
Timepoint [1] 0 0
Approximately 4 years
Primary outcome [2] 0 0
Overall Survival (OS) in TROP2 biomarker positive participants.
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: • TROP2 biomarker positive population The measure of interest is the HR of OS.
Timepoint [2] 0 0
Approximately 6 years
Secondary outcome [1] 0 0
Progression-Free Survival (PFS) in the FAS population.
Assessment method [1] 0 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: • FAS population The measure of interest is the HR of PFS. PFS by investigator will be reported as a sensitivity analysis.
Timepoint [1] 0 0
Approximately 4 years
Secondary outcome [2] 0 0
Overall Survival (OS) in the FAS population.
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: • FAS population The measure of interest is the HR of OS.
Timepoint [2] 0 0
Approximately 6 years
Secondary outcome [3] 0 0
Assessment of Objective Response Rate (ORR) by BICR in TROP2 biomarker positive and FAS populations
Assessment method [3] 0 0
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 * FAS 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.
Timepoint [3] 0 0
Approximately 4 years
Secondary outcome [4] 0 0
Assessment of Duration of Response (DoR) by BICR in TROP2 biomarker positive and FAS populations
Assessment method [4] 0 0
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 * FAS population The measure of interest is the median of DoR. DoR by investigator will be reported as a sensitivity analysis.
Timepoint [4] 0 0
Approximately 4 years
Secondary outcome [5] 0 0
Participant-reported lung cancer symptoms of NSCLC and participant-reported GHS/QOL in participants treated with Dato-DXd in combination with rilvegostomig relative to pembrolizumab.
Assessment method [5] 0 0
Time to deterioration in: pulmonary symptoms (dyspnoea, cough, and chest pain) as measured by the NSCLC-SAQ, in overall lung cancer symptoms as measured by the NSCLC-SAQ, and in GHS/QoL as measured by the GHS/QoL scale from EORTC IL172. 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 * FAS population The measure of interest is the HR of time to deterioration in pulmonary symptoms, HR of time to deterioration in overall lung cancer symptoms, and HR of time to deterioration in GHS/QoL.
Timepoint [5] 0 0
Approximately 6 years
Secondary outcome [6] 0 0
Participant-reported physical functioning in participants treated with Dato DXd in combination with rilvegostomig relative to pembrolizumab.
Assessment method [6] 0 0
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 * FAS population The measure of interest is the HR of time to deterioration in physical functioning.
Timepoint [6] 0 0
Approximately 6 years
Secondary outcome [7] 0 0
Pharmacokinetics (PK)
Assessment method [7] 0 0
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).
Timepoint [7] 0 0
Approximately 6 years
Secondary outcome [8] 0 0
Immunogenicity
Assessment method [8] 0 0
Presence of ADA for Dato-DXd and rilvegostomig (confirmatory results, titres and neutralising antibodies for confirmed positive samples).
Timepoint [8] 0 0
Approximately 6 years
Secondary outcome [9] 0 0
Second Progression-Free Survival (PFS2).
Assessment method [9] 0 0
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 * FAS population The measure of interest is the HR of PFS2.
Timepoint [9] 0 0
Approximately 6 years

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 and available 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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 significant pulmonary function compromise, as determined by the investigator
* 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

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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
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
11/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
24/05/2030
Actual
Sample size
Target
675
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Birtinya
Recruitment hospital [2] 0 0
Research Site - Blacktown
Recruitment hospital [3] 0 0
Research Site - Clayton
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Research Site - Melbourne
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Research Site - South Brisbane
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Research Site - Southport
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Research Site - Wodonga
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4575 - Birtinya
Recruitment postcode(s) [2] 0 0
2148 - Blacktown
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3000 - Melbourne
Recruitment postcode(s) [5] 0 0
QL 4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
4215 - Southport
Recruitment postcode(s) [7] 0 0
3690 - Wodonga
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State/province [153] 0 0
Jerez de la Frontera
Country [154] 0 0
Spain
State/province [154] 0 0
Reus,Tarragona
Country [155] 0 0
Spain
State/province [155] 0 0
Salamanca
Country [156] 0 0
Taiwan
State/province [156] 0 0
Kaohsiung
Country [157] 0 0
Taiwan
State/province [157] 0 0
New Taipei
Country [158] 0 0
Taiwan
State/province [158] 0 0
Taichung
Country [159] 0 0
Taiwan
State/province [159] 0 0
Tainan
Country [160] 0 0
Taiwan
State/province [160] 0 0
Taipei
Country [161] 0 0
Taiwan
State/province [161] 0 0
Taoyuan
Country [162] 0 0
Turkey
State/province [162] 0 0
Adapazari
Country [163] 0 0
Turkey
State/province [163] 0 0
Ankara
Country [164] 0 0
Turkey
State/province [164] 0 0
Antalya
Country [165] 0 0
Turkey
State/province [165] 0 0
Diyarbakir
Country [166] 0 0
Turkey
State/province [166] 0 0
Istanbul
Country [167] 0 0
United Kingdom
State/province [167] 0 0
Cheltenham
Country [168] 0 0
United Kingdom
State/province [168] 0 0
Inverness
Country [169] 0 0
United Kingdom
State/province [169] 0 0
London
Country [170] 0 0
United Kingdom
State/province [170] 0 0
Preston
Country [171] 0 0
United Kingdom
State/province [171] 0 0
Truro

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Daiichi Sankyo
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Suresh S. Ramalingam, MD
Address 0 0
Emory University, Atlanta, Georgia, United States of America.
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Email 0 0
information.center@astrazeneca.com
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06357533