Trial 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
NCT ID:
NCT06357533
Condition:
Non-Small Cell Lung Cancer
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Pembrolizumab
Conditions: Keywords:
NSCLC
Non-Small Cell Lung Cancer
Datopotamab Deruxtecan
Rilvegostomig
Pembrolizumab
Non-squamous
PD-L1 expression >=50%
Locally-advanced NSCLC
Metastatic NSCLC
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Masking description:
Open-label, sponsor-blinded
Intervention:
Intervention type:
Drug
Intervention name:
Datopotamab Deruxtecan
Description:
Datopotamab Deruxtecan IV (intravenous)
Arm group label:
Arm 1: Dato-DXd in Combination With Rilvegostomig
Other name:
Dato-DXd
Intervention type:
Drug
Intervention name:
Rilvegostomig
Description:
Rilvegostomig IV (intravenous)
Arm group label:
Arm 1: Dato-DXd in Combination With Rilvegostomig
Arm group label:
Arm 2: Rilvegostomig Monotherapy
Other name:
AZD2936
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Pembrolizumab IV (intravenous)
Arm group label:
Arm 3: Pembrolizumab Monotherapy
Other name:
KEYTRUDA
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.
Detailed description:
This is a Phase III, randomized, 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.
Criteria for eligibility:
Criteria:
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
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Tucson
Zip:
85719
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Fayetteville
Zip:
72703
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Burbank
Zip:
91505
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Brandon
Zip:
33511
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Orlando
Zip:
32827
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Grand Rapids
Zip:
49503
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Hattiesburg
Zip:
39401
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Omaha
Zip:
68130
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Stony Brook
Zip:
11794
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Greenville
Zip:
27834
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Greenville
Zip:
29607
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Chattanooga
Zip:
37404
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Houston
Zip:
77090
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Kingwood
Zip:
77339
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Fort Belvoir
Zip:
22060
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Leesburg
Zip:
20176
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Tacoma
Zip:
98405
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Clayton
Zip:
3168
Country:
Australia
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Melbourne
Zip:
3000
Country:
Australia
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
South Brisbane
Zip:
QL 4101
Country:
Australia
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Innsbruck
Zip:
6020
Country:
Austria
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Krems
Zip:
3500
Country:
Austria
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Linz
Zip:
4020
Country:
Austria
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Rankweil
Zip:
6830
Country:
Austria
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Wels
Zip:
4600
Country:
Austria
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Wien
Zip:
1140
Country:
Austria
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Wien
Zip:
1210
Country:
Austria
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Anderlecht
Zip:
1070
Country:
Belgium
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Hasselt
Zip:
3500
Country:
Belgium
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
La Louvière
Zip:
7100
Country:
Belgium
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Barretos
Zip:
14784-400
Country:
Brazil
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Curitiba
Zip:
80730-150
Country:
Brazil
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Florianópolis
Zip:
88034-000
Country:
Brazil
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Ipatinga
Zip:
35162-189
Country:
Brazil
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Natal
Zip:
59075-740
Country:
Brazil
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Porto Alegre
Zip:
91350-200
Country:
Brazil
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Rio de Janeiro
Zip:
22211-230
Country:
Brazil
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Santa Maria
Zip:
97015-450
Country:
Brazil
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
São Paulo
Zip:
01221-020
Country:
Brazil
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Taubaté
Zip:
12030-200
Country:
Brazil
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Vancouver
Zip:
VSZ 4E6
Country:
Canada
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Winnipeg
Zip:
R3E 0V9
Country:
Canada
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
London
Zip:
N6A 4L6
Country:
Canada
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Newmarket
Zip:
L3Y 2P9
Country:
Canada
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Oshawa
Zip:
L1G 2B9
Country:
Canada
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Toronto
Zip:
M4N 3M5
Country:
Canada
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Lévis
Zip:
G6V 0B8
Country:
Canada
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Montreal
Zip:
H3T 1E2
Country:
Canada
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Montreal
Zip:
H4J 1C5
Country:
Canada
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Rimouski
Zip:
G5L 5T1
Country:
Canada
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Trois-Rivieres
Zip:
G8Z 3R9
Country:
Canada
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Chicoutimi
Zip:
G7H 5H6
Country:
Canada
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Gauting
Zip:
82131
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Budapest
Zip:
1121
Country:
Hungary
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Gyula
Zip:
5700
Country:
Hungary
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Győr
Zip:
9024
Country:
Hungary
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Kecskemét
Zip:
6000
Country:
Hungary
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Salgótarján
Zip:
3100
Country:
Hungary
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Szekszárd
Zip:
7100
Country:
Hungary
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Székesfehérvár
Zip:
8000
Country:
Hungary
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Törökbálint
Zip:
2045
Country:
Hungary
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Dwarka
Zip:
110075
Country:
India
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Jaipur
Zip:
302004
Country:
India
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Kolkata
Zip:
700099
Country:
India
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Marg Jaipur
Zip:
302004
Country:
India
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Nagpur
Zip:
440001
Country:
India
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Nashik
Zip:
422011
Country:
India
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
New Delhi
Zip:
110085
Country:
India
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
New Delhi
Zip:
11029
Country:
India
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Thiruvananthapuram
Zip:
695011
Country:
India
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Bergamo
Zip:
24125
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Genoa
Zip:
16132
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Milano
Zip:
20141
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Milano
Zip:
20162
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Monza
Zip:
20052
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Padova
Zip:
35128
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Pavia
Zip:
27100
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Ravenna
Zip:
48100
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Roma
Zip:
00128
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Rozzano
Zip:
20089
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Hidaka-shi
Zip:
350-1298
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Kawasaki-shi
Zip:
216-8511
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Nagoya-shi
Zip:
460-0001
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Okayama
Zip:
700-8558
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Sagamihara-shi
Zip:
252-0375
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Sapporo-shi
Zip:
003-0804
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Takaoka-shi
Zip:
933-8555
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Takatsuki-shi
Zip:
569-8686
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Tokushima-shi
Zip:
770-8503
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Tokyo
Zip:
104-0045
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Utsunomiya-shi
Zip:
320-0834
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Changwon
Zip:
51353
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Incheon
Zip:
21565
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seongnam-si
Zip:
13496
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Suwon-si
Zip:
16499
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Suwon
Zip:
16247
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Olsztyn
Zip:
10-357
Country:
Poland
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Poznań
Zip:
60-569
Country:
Poland
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Warszawa
Zip:
01-138
Country:
Poland
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Alicante
Zip:
03010
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Barcelona
Zip:
08003
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Jerez de la Frontera
Zip:
11407
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Reus,Tarragona
Zip:
43204
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Salamanca
Zip:
37007
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Kaohsiung
Zip:
80756
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
New Taipei
Zip:
220
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Taichung
Zip:
40447
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Tainan
Zip:
704
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Taipei
Zip:
10002
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Taipei
Zip:
112
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Taipei
Zip:
TAIWAN
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Taoyuan
Zip:
333
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Adapazarı
Zip:
54100
Country:
Turkey
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Ankara
Zip:
06560
Country:
Turkey
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Ankara
Zip:
6200
Country:
Turkey
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Antalya
Zip:
07070
Country:
Turkey
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Diyarbakir
Zip:
21280
Country:
Turkey
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Istanbul
Zip:
34030
Country:
Turkey
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Istanbul
Zip:
34890
Country:
Turkey
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Cheltenham
Zip:
GL53 7AN
Country:
United Kingdom
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Inverness
Zip:
IV2 3UJ
Country:
United Kingdom
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
London
Zip:
SE1 9RT
Country:
United Kingdom
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
London
Zip:
SW10 9NH
Country:
United Kingdom
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
London
Zip:
SW17 0QT
Country:
United Kingdom
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Truro
Zip:
TR1 3LJ
Country:
United Kingdom
Status:
Not yet recruiting
Start date:
April 11, 2024
Completion date:
May 24, 2030
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Collaborator:
Agency:
Daiichi Sankyo
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06357533
