Étude de phase III, ouverte, sur le Dato-DXd de première intention en association avec le Rilvegostomig pour le CPNPC non épidermoïde avancé avec une expression élevée de PD-L1 (TC ≥ 50 %) et sans altérations génomiques exploitables (TROPION-Lung10)
Une étude mondiale de phase III, randomisée, ouverte, sur le datopotamab Deruxtecan (Dato-DXd) en association avec le Rilvegostomig ou le Rilvegostomig en monothérapie par rapport au pembrolizumab en monothérapie pour le traitement de première intention des participants atteints d'un CPNPC non épidermoïde localement avancé ou métastatique avec un taux élevé Expression PD-L1 (TC ≥ 50 %) et sans altérations génomiques exploitables (TROPION-Lung10)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This is a Phase III, randomized, open-label, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig monotherapy compared with 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.
Type d'étude
Inscription (Estimé)
Phase
- Phase 3
Contacts et emplacements
Coordonnées de l'étude
- Nom: AstraZeneca Clinical Study Information Center
- Numéro de téléphone: 1-877-240-9479
- E-mail: information.center@astrazeneca.com
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Berlin, Allemagne, 10249
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Bonn, Allemagne, 53113
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Cologne, Allemagne, 50677
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Düsseldorf, Allemagne, 40489
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Essen, Allemagne, 45136
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Freiburg im Breisgau, Allemagne, 79106
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Gauting, Allemagne, 82131
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Georgsmarienhütte, Allemagne, 49124
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Gera, Allemagne, 07548
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Gütersloh, Allemagne, 33332
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Hamburg, Allemagne, 20251
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Hamburg, Allemagne, 22087
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Heidelberg, Allemagne, 69126
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Kempten, Allemagne, 87439
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Kiel, Allemagne, 24116
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Koblenz, Allemagne, 56068
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München, Allemagne, 81925
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Nuremberg, Allemagne, 90419
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Ravensburg, Allemagne, 88212
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Birtinya, Australie, 4575
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Blacktown, Australie, 2148
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Clayton, Australie, 3168
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Gosford, Australie, 2250
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Melbourne, Australie, 3000
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La Louvière, Belgique, 7100
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Liège, Belgique, 4000
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Barretos, Brésil, 14784-400
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Natal, Brésil, 59075-740
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Santa Maria, Brésil, 97015-450
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Taubaté, Brésil, 12030-200
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Winnipeg, Manitoba, Canada, R3E 0V9
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St. John's, Newfoundland and Labrador, Canada, A1B 3V6
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London, Ontario, Canada, N6A 4L6
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Yangzhou, Chine, 225001
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Changwon, Corée du Sud, 51353
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Incheon, Corée du Sud, 21565
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Seongnam-si, Corée du Sud, 13496
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Seoul, Corée du Sud, 03080
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Seoul, Corée du Sud, 03722
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Seoul, Corée du Sud, 08308
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Seoul, Corée du Sud, 06973
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Suwon, Corée du Sud, 16247
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Suwon, Corée du Sud, 16499
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Alicante, Espagne, 03010
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Barcelona, Espagne, 08036
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Barcelona, Espagne, 08003
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Jerez de la Frontera, Espagne, 11407
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Reus, Espagne, 43204
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Salamanca, Espagne, 37007
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Budapest, Hongrie, 1121
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Gyula, Hongrie, 5700
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Gyöngyös - Mátraháza, Hongrie, 3200
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Győr, Hongrie, 9024
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Kecskemét, Hongrie, 6000
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Salgótarján, Hongrie, 3100
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Szekszárd, Hongrie, 7100
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Szolnok, Hongrie, 5000
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Székesfehérvár, Hongrie, 8000
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Törökbálint, Hongrie, 2045
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Chennai, Inde, 600031
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Dwārka, Inde, 110075
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Jaipur, Inde, 302004
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Kolkata, Inde, 700099
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Marg Jaipur, Inde, 302004
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Nagpur, Inde, 440001
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Nashik, Inde, 422011
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New Delhi, Inde, 11029
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New Delhi, Inde, 110085
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Surat, Inde, 395002
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Thiruvananthapuram, Inde, 695011
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Bergamo, Italie, 24125
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Genoa, Italie, 16132
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Milan, Italie, 20141
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Milan, Italie, 20162
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Monza, Italie, 20052
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Padova, Italie, 35128
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Pavia, Italie, 27100
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Ravenna, Italie, 48100
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Roma, Italie, 00128
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Rozzano, Italie, 20089
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Bunkyō City, Japon, 113-8431
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Bunkyō City, Japon, 160-0023
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Fukuoka, Japon, 812-8582
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Fukuoka, Japon, 814-0180
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Hakodate-shi, Japon, 040-8611
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Hidaka-shi, Japon, 350-1298
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London, Royaume-Uni, SW10 9NH
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Nevada
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Las Vegas, Nevada, États-Unis, 89102
- Recrutement
- Research Site
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Reno, Nevada, États-Unis, 89502
- Retiré
- Research Site
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New Jersey
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Voorhees Township, New Jersey, États-Unis, 08043
- Suspendu
- Research Site
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New York
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Stony Brook, New York, États-Unis, 11794
- Recrutement
- Research Site
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North Carolina
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Greenville, North Carolina, États-Unis, 27834
- Recrutement
- Research Site
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Salisbury, North Carolina, États-Unis, 28144
- Recrutement
- Research Site
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Ohio
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Cincinnati, Ohio, États-Unis, 45219
- Recrutement
- Research Site
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Columbus, Ohio, États-Unis, 43210
- Retiré
- Research Site
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Maumee, Ohio, États-Unis, 43537
- Recrutement
- Research Site
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Toledo, Ohio, États-Unis, 43623
- Recrutement
- Research Site
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Oregon
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Portland, Oregon, États-Unis, 97213
- Retiré
- Research Site
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South Carolina
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Greenville, South Carolina, États-Unis, 29607
- Recrutement
- Research Site
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South Dakota
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Sioux Falls, South Dakota, États-Unis, 57105
- Recrutement
- Research Site
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Tennessee
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Chattanooga, Tennessee, États-Unis, 37404
- Retiré
- Research Site
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Knoxville, Tennessee, États-Unis, 37920
- Retiré
- Research Site
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Texas
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Fort Worth, Texas, États-Unis, 76104
- Recrutement
- Research Site
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Houston, Texas, États-Unis, 77030
- Recrutement
- Research Site
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Houston, Texas, États-Unis, 77030
- Retiré
- Research Site
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Houston, Texas, États-Unis, 77090
- Suspendu
- Research Site
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Kingwood, Texas, États-Unis, 77339
- Recrutement
- Research Site
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Odessa, Texas, États-Unis, 79761
- Recrutement
- Research Site
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Virginia
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Fort Belvoir, Virginia, États-Unis, 22060
- Recrutement
- Research Site
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Leesburg, Virginia, États-Unis, 20176
- Recrutement
- Research Site
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Midlothian, Virginia, États-Unis, 23114
- Recrutement
- Research Site
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Richmond, Virginia, États-Unis, 23230
- Recrutement
- Research Site
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Washington
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Tacoma, Washington, États-Unis, 98405
- Recrutement
- Research Site
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Vancouver, Washington, États-Unis, 98684
- Recrutement
- Research Site
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Wenatchee, Washington, États-Unis, 98801
- Recrutement
- Research Site
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Wisconsin
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Appleton, Wisconsin, États-Unis, 54911
- Recrutement
- Research Site
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
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 disease that makes it undesirable for the participant to participate in the study or that would jeopardies compliance with the protocol.
- Has clinically significant third-space fluid retention (for example pleural effusion) and is not amenable for repeated drainage.
- History of any ILD/pneumonitis, including radiation pneumonitis (apart from radiation pneumonitis that did not require steroids), or drug-induced ILD/pneumonitis, has current or 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
Datopotamab Deruxtecan IV (intravenous)
Autres noms:
Rilvegostomig IV (intravenous)
Autres noms:
|
|
Expérimental: 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. |
Rilvegostomig IV (intravenous)
Autres noms:
|
|
Comparateur actif: 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. |
Pembrolizumab IV (intravenous)
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Progression-Free Survival (PFS) in TROP2 biomarker positive participants.
Délai: Approximately 4 years
|
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. |
Approximately 4 years
|
|
Overall Survival (OS) in TROP2 biomarker positive participants.
Délai: Approximately 6 years
|
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. |
Approximately 6 years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Progression-Free Survival (PFS) in the FAS population.
Délai: Approximately 4 years
|
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. |
Approximately 4 years
|
|
Overall Survival (OS) in the FAS population.
Délai: Approximately 6 years
|
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. |
Approximately 6 years
|
|
Assessment of Objective Response Rate (ORR) by BICR in TROP2 biomarker positive and FAS populations
Délai: Approximately 4 years
|
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:
The measure of interest is the difference of the ORR. ORR by investigator will be reported as a sensitivity analysis. |
Approximately 4 years
|
|
Assessment of Duration of Response (DoR) by BICR in TROP2 biomarker positive and FAS populations
Délai: Approximately 4 years
|
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 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:
|
Approximately 4 years
|
|
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.
Délai: Approximately 6 years
|
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:
|
Approximately 6 years
|
|
Participant-reported physical functioning in participants treated with Dato DXd in combination with rilvegostomig relative to pembrolizumab.
Délai: Approximately 6 years
|
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:
|
Approximately 6 years
|
|
Pharmacokinetics (PK)
Délai: Approximately 6 years
|
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). |
Approximately 6 years
|
|
Immunogenicity
Délai: Approximately 6 years
|
Presence of ADA for Dato-DXd and rilvegostomig (confirmatory results, titres and neutralising antibodies for confirmed positive samples). |
Approximately 6 years
|
|
Second Progression-Free Survival (PFS2).
Délai: Approximately 6 years
|
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:
|
Approximately 6 years
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Safety of Dato-DXd in combination with rilvegostomig and rilvegostomig monotherapy as compared with pembrolizumab.
Délai: Approximately 6 years
|
Safety and tolerability will be evaluated in terms of AEs (graded by CTCAE Version 5.0). |
Approximately 6 years
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Suresh S. Ramalingam, MD, Emory University, Atlanta, Georgia, United States of America.
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- D7632C00001
- 2023-505077-32-00 (Identificateur de registre: CTIS (EU))
- 2023 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
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
Délai de partage IPD
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
Critères d'accès au partage IPD
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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
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