Register a trial

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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
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
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.
Timepoint [1] 0 0
Approximately 4 years
Primary outcome [2] 0 0
Overall Survival (OS) in TROP2 biomarker positive participants.
Timepoint [2] 0 0
Approximately 6 years
Secondary outcome [1] 0 0
Progression-Free Survival (PFS) in the FAS population.
Timepoint [1] 0 0
Approximately 4 years
Secondary outcome [2] 0 0
Overall Survival (OS) in the FAS population.
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
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
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.
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.
Timepoint [6] 0 0
Approximately 6 years
Secondary outcome [7] 0 0
Pharmacokinetics (PK)
Timepoint [7] 0 0
Approximately 6 years
Secondary outcome [8] 0 0
Immunogenicity
Timepoint [8] 0 0
Approximately 6 years
Secondary outcome [9] 0 0
Second Progression-Free Survival (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 - Blacktown
Recruitment hospital [2] 0 0
Research Site - Clayton
Recruitment hospital [3] 0 0
Research Site - Melbourne
Recruitment hospital [4] 0 0
Research Site - South Brisbane
Recruitment hospital [5] 0 0
Research Site - Southport
Recruitment hospital [6] 0 0
Research Site - Wodonga
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
Recruitment postcode(s) [4] 0 0
QL 4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
4215 - Southport
Recruitment postcode(s) [6] 0 0
3690 - Wodonga
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alaska
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Mississippi
Country [12] 0 0
United States of America
State/province [12] 0 0
Montana
Country [13] 0 0
United States of America
State/province [13] 0 0
Nebraska
Country [14] 0 0
United States of America
State/province [14] 0 0
Nevada
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Oregon
Country [20] 0 0
United States of America
State/province [20] 0 0
South Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
South Dakota
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Virginia
Country [25] 0 0
United States of America
State/province [25] 0 0
Washington
Country [26] 0 0
Austria
State/province [26] 0 0
Innsbruck
Country [27] 0 0
Austria
State/province [27] 0 0
Krems
Country [28] 0 0
Austria
State/province [28] 0 0
Linz
Country [29] 0 0
Austria
State/province [29] 0 0
Rankweil
Country [30] 0 0
Austria
State/province [30] 0 0
Wels
Country [31] 0 0
Austria
State/province [31] 0 0
Wien
Country [32] 0 0
Belgium
State/province [32] 0 0
Anderlecht
Country [33] 0 0
Belgium
State/province [33] 0 0
Hasselt
Country [34] 0 0
Belgium
State/province [34] 0 0
La Louvière
Country [35] 0 0
Belgium
State/province [35] 0 0
Liège
Country [36] 0 0
Brazil
State/province [36] 0 0
Barretos
Country [37] 0 0
Brazil
State/province [37] 0 0
Curitiba
Country [38] 0 0
Brazil
State/province [38] 0 0
Florianópolis
Country [39] 0 0
Brazil
State/province [39] 0 0
Ipatinga
Country [40] 0 0
Brazil
State/province [40] 0 0
Natal
Country [41] 0 0
Brazil
State/province [41] 0 0
Porto Alegre
Country [42] 0 0
Brazil
State/province [42] 0 0
Rio de Janeiro
Country [43] 0 0
Brazil
State/province [43] 0 0
Santa Maria
Country [44] 0 0
Brazil
State/province [44] 0 0
São Paulo
Country [45] 0 0
Brazil
State/province [45] 0 0
Taubaté
Country [46] 0 0
Canada
State/province [46] 0 0
British Columbia
Country [47] 0 0
Canada
State/province [47] 0 0
Manitoba
Country [48] 0 0
Canada
State/province [48] 0 0
Newfoundland and Labrador
Country [49] 0 0
Canada
State/province [49] 0 0
Ontario
Country [50] 0 0
Canada
State/province [50] 0 0
Quebec
Country [51] 0 0
Canada
State/province [51] 0 0
Saskatchewan
Country [52] 0 0
Canada
State/province [52] 0 0
Chicoutimi
Country [53] 0 0
China
State/province [53] 0 0
Beijing
Country [54] 0 0
China
State/province [54] 0 0
Changsha
Country [55] 0 0
China
State/province [55] 0 0
Chengdu
Country [56] 0 0
China
State/province [56] 0 0
Chongqing
Country [57] 0 0
China
State/province [57] 0 0
Fuzhou
Country [58] 0 0
China
State/province [58] 0 0
Guangzhou
Country [59] 0 0
China
State/province [59] 0 0
Nanning
Country [60] 0 0
China
State/province [60] 0 0
Shanghai
Country [61] 0 0
China
State/province [61] 0 0
Wuhan
Country [62] 0 0
Germany
State/province [62] 0 0
Bonn
Country [63] 0 0
Germany
State/province [63] 0 0
Düsseldorf
Country [64] 0 0
Germany
State/province [64] 0 0
Freiburg
Country [65] 0 0
Germany
State/province [65] 0 0
Gauting
Country [66] 0 0
Germany
State/province [66] 0 0
Georgsmarienhütte
Country [67] 0 0
Germany
State/province [67] 0 0
Gera
Country [68] 0 0
Germany
State/province [68] 0 0
Gütersloh
Country [69] 0 0
Germany
State/province [69] 0 0
Hamburg
Country [70] 0 0
Germany
State/province [70] 0 0
Heidelberg
Country [71] 0 0
Germany
State/province [71] 0 0
Kempten
Country [72] 0 0
Germany
State/province [72] 0 0
Koblenz
Country [73] 0 0
Germany
State/province [73] 0 0
Ludwigsburg
Country [74] 0 0
Germany
State/province [74] 0 0
München
Country [75] 0 0
Germany
State/province [75] 0 0
Nürnberg
Country [76] 0 0
Germany
State/province [76] 0 0
Ravensburg
Country [77] 0 0
Hungary
State/province [77] 0 0
Budapest
Country [78] 0 0
Hungary
State/province [78] 0 0
Gyula
Country [79] 0 0
Hungary
State/province [79] 0 0
Gyöngyös
Country [80] 0 0
Hungary
State/province [80] 0 0
Gyor
Country [81] 0 0
Hungary
State/province [81] 0 0
Kecskemét
Country [82] 0 0
Hungary
State/province [82] 0 0
Salgótarján
Country [83] 0 0
Hungary
State/province [83] 0 0
Szekszárd
Country [84] 0 0
Hungary
State/province [84] 0 0
Székesfehérvár
Country [85] 0 0
Hungary
State/province [85] 0 0
Törökbálint
Country [86] 0 0
India
State/province [86] 0 0
Chennai
Country [87] 0 0
India
State/province [87] 0 0
Dwarka
Country [88] 0 0
India
State/province [88] 0 0
Jaipur
Country [89] 0 0
India
State/province [89] 0 0
Kolkata
Country [90] 0 0
India
State/province [90] 0 0
Marg Jaipur
Country [91] 0 0
India
State/province [91] 0 0
Nagpur
Country [92] 0 0
India
State/province [92] 0 0
Nashik
Country [93] 0 0
India
State/province [93] 0 0
New Delhi
Country [94] 0 0
India
State/province [94] 0 0
Thiruvananthapuram
Country [95] 0 0
Italy
State/province [95] 0 0
Bergamo
Country [96] 0 0
Italy
State/province [96] 0 0
Genoa
Country [97] 0 0
Italy
State/province [97] 0 0
Milano
Country [98] 0 0
Italy
State/province [98] 0 0
Monza
Country [99] 0 0
Italy
State/province [99] 0 0
Padova
Country [100] 0 0
Italy
State/province [100] 0 0
Pavia
Country [101] 0 0
Italy
State/province [101] 0 0
Ravenna
Country [102] 0 0
Italy
State/province [102] 0 0
Roma
Country [103] 0 0
Italy
State/province [103] 0 0
Rozzano
Country [104] 0 0
Japan
State/province [104] 0 0
Fukuoka-shi
Country [105] 0 0
Japan
State/province [105] 0 0
Hidaka-shi
Country [106] 0 0
Japan
State/province [106] 0 0
Hirosaki-shi
Country [107] 0 0
Japan
State/province [107] 0 0
Hiroshima-shi
Country [108] 0 0
Japan
State/province [108] 0 0
Kawasaki-shi
Country [109] 0 0
Japan
State/province [109] 0 0
Kumamoto-shi
Country [110] 0 0
Japan
State/province [110] 0 0
Nagoya-shi
Country [111] 0 0
Japan
State/province [111] 0 0
Okayama
Country [112] 0 0
Japan
State/province [112] 0 0
Osakasayama-shi
Country [113] 0 0
Japan
State/province [113] 0 0
Osaka
Country [114] 0 0
Japan
State/province [114] 0 0
Sagamihara-shi
Country [115] 0 0
Japan
State/province [115] 0 0
Sapporo-shi
Country [116] 0 0
Japan
State/province [116] 0 0
Takaoka-shi
Country [117] 0 0
Japan
State/province [117] 0 0
Takatsuki-shi
Country [118] 0 0
Japan
State/province [118] 0 0
Tokushima-shi
Country [119] 0 0
Japan
State/province [119] 0 0
Tokyo
Country [120] 0 0
Japan
State/province [120] 0 0
Utsunomiya-shi
Country [121] 0 0
Japan
State/province [121] 0 0
Yokohama-shi
Country [122] 0 0
Korea, Republic of
State/province [122] 0 0
Changwon
Country [123] 0 0
Korea, Republic of
State/province [123] 0 0
Incheon
Country [124] 0 0
Korea, Republic of
State/province [124] 0 0
Seongnam-si
Country [125] 0 0
Korea, Republic of
State/province [125] 0 0
Seoul
Country [126] 0 0
Korea, Republic of
State/province [126] 0 0
Suwon-si
Country [127] 0 0
Korea, Republic of
State/province [127] 0 0
Suwon
Country [128] 0 0
Poland
State/province [128] 0 0
Olsztyn
Country [129] 0 0
Poland
State/province [129] 0 0
Poznan
Country [130] 0 0
Poland
State/province [130] 0 0
Przemysl
Country [131] 0 0
Poland
State/province [131] 0 0
Warszawa
Country [132] 0 0
Puerto Rico
State/province [132] 0 0
San Juan
Country [133] 0 0
Spain
State/province [133] 0 0
Alicante
Country [134] 0 0
Spain
State/province [134] 0 0
Barcelona
Country [135] 0 0
Spain
State/province [135] 0 0
Jerez de la Frontera
Country [136] 0 0
Spain
State/province [136] 0 0
Reus,Tarragona
Country [137] 0 0
Spain
State/province [137] 0 0
Salamanca
Country [138] 0 0
Taiwan
State/province [138] 0 0
Kaohsiung
Country [139] 0 0
Taiwan
State/province [139] 0 0
New Taipei
Country [140] 0 0
Taiwan
State/province [140] 0 0
Taichung
Country [141] 0 0
Taiwan
State/province [141] 0 0
Tainan
Country [142] 0 0
Taiwan
State/province [142] 0 0
Taipei
Country [143] 0 0
Taiwan
State/province [143] 0 0
Taoyuan
Country [144] 0 0
Turkey
State/province [144] 0 0
Adapazari
Country [145] 0 0
Turkey
State/province [145] 0 0
Ankara
Country [146] 0 0
Turkey
State/province [146] 0 0
Antalya
Country [147] 0 0
Turkey
State/province [147] 0 0
Diyarbakir
Country [148] 0 0
Turkey
State/province [148] 0 0
Istanbul
Country [149] 0 0
United Kingdom
State/province [149] 0 0
Cheltenham
Country [150] 0 0
United Kingdom
State/province [150] 0 0
Inverness
Country [151] 0 0
United Kingdom
State/province [151] 0 0
London
Country [152] 0 0
United Kingdom
State/province [152] 0 0
Preston
Country [153] 0 0
United Kingdom
State/province [153] 0 0
Truro

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
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
Fax 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
Fax 0 0
Email 0 0
information.center@astrazeneca.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles.

For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Available to whom?
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool .

Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


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