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JOURNAL ONKOLOGIE – STUDIE

MERMAID-2 Phase III Study to Determine Efficacy of Durvalumab in Stage II-III Non-small Cell Lung Cancer (NSCLC) After Curative Intent Therapy.

Rekrutierend

NCT-Nummer:
NCT04642469

Studienbeginn:
November 2020

Letztes Update:
21.12.2020

Wirkstoff:
Durvalumab

Indikation (Clinical Trials):
Carcinoma, Non-Small-Cell Lung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
AstraZeneca

Collaborator:
-

Studienleiter

David Spigel
Principal Investigator
SCRI Development Innovations, LLC

Kontakt

AstraZeneca Clinical Study Information Center
Kontakt:
Phone: 1-877-240-9479
E-Mail: information.center@astrazeneca.com» Kontaktdaten anzeigen

Studienlocations (3 von 104)

Research Site
73730 Esslingen
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
82131 Gauting
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
37075 Göttingen
(Niedersachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
51109 Köln
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
48149 Münster
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
93049 Regensburg
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
97078 Würzburg
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
90033 Los Angeles
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
95403 Santa Rosa
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
30060 Marietta
United StatesNoch nicht rekrutierend» Google-Maps
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20910 Silver Spring
United StatesNoch nicht rekrutierend» Google-Maps
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55407 Minneapolis
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
68510 Lincoln
United StatesNoch nicht rekrutierend» Google-Maps
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87102 Albuquerque
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
29650 Greer
United StatesNoch nicht rekrutierend» Google-Maps
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37404 Chattanooga
United StatesNoch nicht rekrutierend» Google-Maps
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78229 San Antonio
United StatesNoch nicht rekrutierend» Google-Maps
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22031 Fairfax
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
98108-1532 Seattle
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
2050 Camperdown
AustraliaNoch nicht rekrutierend» Google-Maps
Research Site
155 62 Holargos, Athens
GreeceNoch nicht rekrutierend» Google-Maps
Research Site
54645 Thessaloniki
GreeceNoch nicht rekrutierend» Google-Maps
Research Site
673-8558 Akashi-shi
JapanNoch nicht rekrutierend» Google-Maps
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734-8551 Hiroshima-shi
JapanNoch nicht rekrutierend» Google-Maps
Research Site
980-0873 Sendai-shi
JapanNoch nicht rekrutierend» Google-Maps
Research Site
241-8515 Yokohama-shi
JapanNoch nicht rekrutierend» Google-Maps
Research Site
28644 Cheongju-si
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Research Site
05505 Seoul
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Research Site
06351 Seoul
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Research Site
06591 Seoul
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Research Site
16247 Suwon
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Research Site
4818 CK Breda
NetherlandsNoch nicht rekrutierend» Google-Maps
Research Site
6202 AZ Maastricht
NetherlandsNoch nicht rekrutierend» Google-Maps
Research Site
8025 AB Zwolle
NetherlandsNoch nicht rekrutierend» Google-Maps
Research Site
97-200 Tomaszów Mazowiecki
PolandNoch nicht rekrutierend» Google-Maps
Research Site
15706 Santiago de Compostela
SpainNoch nicht rekrutierend» Google-Maps
Research Site
CH-1011 Lausanne
SwitzerlandNoch nicht rekrutierend» Google-Maps
Research Site
OX3 7LJ Headington
United KingdomNoch nicht rekrutierend» Google-Maps
Research Site
LS9 7TF Leeds
United KingdomNoch nicht rekrutierend» Google-Maps
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SW3 6JJ London
United KingdomNoch nicht rekrutierend» Google-Maps
Research Site
WC1N 3BG London
United KingdomNoch nicht rekrutierend» Google-Maps
Research Site
M23 9LT Manchester
United KingdomNoch nicht rekrutierend» Google-Maps
Research Site
SM2 5PT Surrey
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Research Site
70000 Ho Chi Minh
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Studien-Informationen

Detailed Description:

This is a Phase III, randomized, multicenter, double-blind, placebo-controlled, study to

evaluate the efficacy and safety of durvalumab adjuvant therapy compared to placebo in

patients with completely resected stage II-III NSCLC who have undergone curative intent

therapy (complete resection ± neoadjuvant and/or adjuvant therapy), who have no evidence of

Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1-defined disease recurrence,

and who become MRD+ during a 96-week surveillance period.

Ein-/Ausschlusskriterien

Inclusion Criteria:

1. Capable of giving signed informed consent which includes compliance with the

requirements and restrictions listed in the ICFs and in the protocol.

2. Age ≥18 years at the time of screening (ICF1);

3. Histologically confirmed NSCLC with resectable stage II-III disease

4. Complete resection of the primary NSCLC

Exclusion Criteria:

1. EGFR and/or ALK mutant

2. Mixed small cell and NSCLC histology

3. History of allogeneic organ or bone marrow transplantation

4. History of active primary immunodeficiency

Studien-Rationale

Primary outcome:

1. DFS in PD-L1 TC≥1% (using Investigator assessments according to RECIST 1.1) (Time Frame - Approximately 5 years):
To assess the efficacy of durvalumab compared to placebo as measured by DFS in the PD-L1 TC≥1% analysis set



Secondary outcome:

1. DFS in FAS (using Investigator assessments according to RECIST 1.1) (Time Frame - approximately 5 years):
To assess the efficacy of durvalumab compared to placebo as measured by DFS in all randomized patients

2. PFS (using local standard practice) (Time Frame - Approximately 5 years):
To assess the efficacy of durvalumab compared to placebo on post-recurrence outcomes

3. Time to first subsequent therapy (TFST) (Time Frame - Approximately 5 years):
To assess the efficacy of durvalumab compared to placebo on post-recurrence outcomes

4. Time to second subsequent therapy (TSST) (Time Frame - Approximately 5 years):
To assess the efficacy of durvalumab compared to placebo on post-recurrence outcomes

5. Change from baseline in EORTC QLQ-C30 (Time Frame - Approximately 5 years):
To assess patient-reported symptoms, functioning, and HRQoL in patients treated with durvalumab compared to placebo

6. Change from baseline in EORTC QLQ-LC13 (Time Frame - Approximately 5 years):
To assess patient-reported symptoms, functioning,and HRQoL in patients treated with durvalumab compared to placebo

7. Time to deterioration in EORTC QLQ-C30 (Time Frame - Approximately 5 years):
To assess patient-reported symptoms, functioning, and HRQoL in patients treated with durvalumab compared to placebo

8. Time to deterioration in EORTC QLQ-LC13 (Time Frame - Approximately 5 years):
To assess patient-reported symptoms, functioning,and HRQoL in patients treated with durvalumab compared to placebo

9. IHC analysis of PD-L1 TC expression and spatial distribution within the tumor microenvironment relative to efficacy outcomes (ie, DFS, OS)The Ventana SP263 PD-L1 immunohistochemistry (IHC) assay will be used to determine PDL1 status in all specimens. (Time Frame - Approximately 5 years):
To investigate the relationship between a patient's baseline PD-L1 TC expression and efficacy of study treatments

10. DFS (using BICR assessments according to RECIST 1.1) in PD-L1 TC≥1% analysis set (Time Frame - Approximately 5 years):
To assess the efficacy of durvalumab compared to placebo as measured by DFS in the PD-L1 TC≥1% analysis set

11. DFS (using BICR assessments according to RECIST 1.1) in FAS (Time Frame - Approximately 5 years):
To assess the efficacy of durvalumab compared to placebo as measured by DFS in all randomized patients.

12. OS in PD-L1 TC≥1% analysis set (Time Frame - Approximately 7 years):
To assess the efficacy of durvalumab compared to placebo as measured by OS in the PD-L1 TC≥1% analysis set

13. OS in FAS (Time Frame - Approximately 7 years):
To assess the efficacy of durvalumab compared to placebo as measured by OS in all randomized patients

Studien-Arme

  • Experimental: Durvalumab
    Intravenous administration of Durvalumab
  • Placebo Comparator: Placebo
    Intravenous administration of placebo

Geprüfte Regime

  • Durvalumab (Medi4736):
    Intravenous administration of Durvalumab
  • Placebo:
    Placebo Comparator

Quelle: ClinicalTrials.gov


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