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JOURNAL ONKOLOGIE – STUDIE
eVOLVE-Lung02

A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer.

Rekrutierend

NCT-Nummer:
NCT05984277

Studienbeginn:
Oktober 2023

Letztes Update:
09.08.2024

Wirkstoff:
Volrustomig, Pembrolizumab, Carboplatin, Paclitaxel, Pemetrexed

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

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
AstraZeneca

Collaborator:
-

Kontakt

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

Studienlocations
(3 von 242)

Research Site
14165 Berlin-Zehlendorf
(Berlin)
GermanyRekrutierend» Google-Maps
Research Site
53127 Bonn
(Nordrhein-Westfalen)
GermanyZurückgezogen» Google-Maps
Research Site
45136 Essen
(Nordrhein-Westfalen)
GermanyZurückgezogen» Google-Maps
Research Site
49124 Georgsmarienhuette
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Research Site
69126 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Research Site
56068 Koblenz
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps
Research Site
72076 Tuebingen
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
86301 Prescott
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
71913 Hot Springs National Park
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
80124 Lone Tree
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
33901 Fort Myers
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
32827 Orlando
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
33705 Saint Petersburg
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
33401 West Palm Beach
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
46202 Indianapolis
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
40206 Louisville
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
21201 Baltimore
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
20904 Silver Spring
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
21204 Towson
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
48202 Detroit
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
11366 Fresh Meadows
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
43210 Columbus
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
43219 Columbus
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
45428 Dayton
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
97239 Portland
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
19044 Horsham
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
15213 Pittsburgh
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
37203 Nashville
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
37212 Nashville
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
75216 Lancaster
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
X5800HHW Ciudad de Córdoba
ArgentinaRekrutierend» Google-Maps
Research Site
14784-400 Barretos
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
80730-150 Curitiba
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
88034-000 Florianópolis
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
60336-045 Fortaleza
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
90619-900 Porto Alegre
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
91350200 Porto Alegre
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
22281-100 Rio De Janeiro
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
96810-110 Santa Cruz do Sul
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
01221-020 Sao Paulo
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
G8Z 3R0 Trois-Rivières
CanadaNoch nicht rekrutierend» Google-Maps
Research Site
G7H 5H6 Chicoutimi
CanadaNoch nicht rekrutierend» Google-Maps
Research Site
703 84 Ostrava - Vitkovice
CzechiaNoch nicht rekrutierend» Google-Maps
Research Site
3200 Gyöngyös - Mátraháza
HungaryZurückgezogen» Google-Maps
Research Site
8000 Székesfehérvár
HungaryNoch nicht rekrutierend» Google-Maps
Research Site
980-0873 Sendai-shi
JapanNoch nicht rekrutierend» Google-Maps
Research Site
28644 Cheongju-si
Korea, Republic ofRekrutierend» Google-Maps
Research Site
03840 Ciudad de México
MexicoNoch nicht rekrutierend» Google-Maps
Research Site
06700 Ciudad de México
MexicoNoch nicht rekrutierend» Google-Maps
Research Site
'14080 Mexico City
MexicoNoch nicht rekrutierend» Google-Maps
Research Site
58-580 Szklarska Poręba
PolandNoch nicht rekrutierend» Google-Maps
Research Site
97-200 Tomaszów Mazowiecki
PolandZurückgezogen» Google-Maps
Research Site
97517 Banska Bystrica
SlovakiaNoch nicht rekrutierend» Google-Maps
Research Site
82606 Bratislava
SlovakiaNoch nicht rekrutierend» Google-Maps
Research Site
833 01 Bratislava
SlovakiaNoch nicht rekrutierend» Google-Maps
Research Site
9301 Bloemfontein
South AfricaNoch nicht rekrutierend» Google-Maps
Research Site
2193 Parktown
South AfricaNoch nicht rekrutierend» Google-Maps
Research Site
IP332QZ Bury St Edmunds
United KingdomNoch nicht rekrutierend» Google-Maps
Research Site
CO4 5JL Colchester
United KingdomNoch nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

Adult patients with a histologically or cytologically documented metastatic NSCLC, with

tumors that lack activating EGFR, ALK, and ROS1 alterations are eligible for enrollment.

Patients will be randomized in a 1:1 ratio to receive treatment with volrustomig +

chemotherapy or pembrolizumab + chemotherapy. Tumor evaluation scans will be performed

until disease progression as efficacy assessment. All patients will be followed for

survival until the end of the study. An data monitoring committee (DMC) composed of

independent experts will be convened to confirm the safety and tolerability of the

proposed dose and schedule.

Ein-/Ausschlusskriterien

Key Inclusion Criteria:

- Histologically or cytologically documented squamous or non-squamous NSCLC.

- Stage IV NSCLC (according to Version 8 of the IASLC Staging Manual in Thoracic

Oncology 2016), not amenable to curative surgery or radiation.

- Absence of sensitizing EGFR mutations and ALK and ROS1 rearrangements.

- Absence of documented tumor genomic alteration results from tests conducted as part

of standard local practice in any other actionable driver oncogenes for which there

are locally approved targeted first-line therapies.

Key Exclusion Criteria:

- Mixed small-cell lung cancer and NSCLC histology or sarcomatoid variant. Rare

subtypes are excluded.

- Spinal cord compression.

- Symptomatic brain metastases. Brain metastases may be treated or untreated, but

participants must be asymptomatic and off steroids for at least 14 days prior to

start of study intervention. A minimum of 2 weeks must have elapsed between the end

of whole brain radiotherapy and study enrollment.

- History of another primary malignancy except for:

1. Malignancy treated with curative intent with no known active disease ≥ 2 years

before the first dose of study intervention and of low potential risk for

recurrence.

2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence

of disease.

3. Adequately treated carcinoma in situ without evidence of disease.

- As judged by the investigator, any condition that would interfere with evaluation of

the study intervention or interpretation of participant safety or study results.

Studien-Rationale

Primary outcome:

1. Progression-Free Survival (PFS) (using BICR assessments according to RECIST 1.1) (Time Frame - Up to approximately 6 years):
PFS is defined as the time from randomization until radiological progression per RECIST 1.1 as assessed by BICR, or death due to any cause (in the absence of progression), in PD-L1-negative participants.

2. Overall Survival (OS), in PD-L1-negative participants. (Time Frame - Up to approximately 6 years):
OS is defined as the time from randomization until the date of death due to any cause, in PD-L1-negative participants.

Secondary outcome:

1. PFS (using BICR assessments according to RECIST 1.1) (Time Frame - Up to approximately 6 years):
PFS is defined as the time from randomization until radiological progression per RECIST 1.1 as assessed by BICR, or death due to any cause (in the absence of progression). The analysis will include all randomized participants.

2. OS (Time Frame - Up to approximately 6 years):
OS is defined as the time from randomization until the date of death due to any cause. The analysis will include all randomized participants.

3. PFS (using Investigator assessments according to RECIST 1.1) (Time Frame - Up to approximately 6 years):
PFS is defined as the time from randomization until radiological progression per RECIST 1.1 as assessed by investigator, or death due to any cause (in the absence of progression).

4. Overall Response Rate (ORR) (Time Frame - Up to approximately 6 years):
ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined by BICR assessments using RECIST 1.1.

5. Duration of Response (DoR) (Time Frame - Up to approximately 6 years):
DoR is defined as the time from the date of first documented response until the date of documented progression per BICR assessments using RECIST 1.1 or death due to any cause (in the absence of progression). These analyses will include participants who have a confirmed response.

6. PFS2 (Time Frame - Up to approximately 6 years):
PFS2 is defined as the time from randomization until the earliest of the progression event (following the initial investigator-assessed progression) after the start of the first subsequent therapy, or death. The date of second progression will be recorded by the investigator in the eCRF and defined according to local standard clinical practice.

7. Concentration of volrustomig in serum and PK parameters (Time Frame - Up to approximately 6 years):
To assess the PK of volrustomig

8. Presence of ADAs against volrustomig in serum (Time Frame - Up to approximately 6 years):
To investigate the immunogenicity of volrustomig.

9. Time-To-Deterioration (TTD) in physical functioning (Time Frame - Up to approximately 6 years):
To assess participant-reported physical functioning in participants treated with volrustomig plus chemotherapy and pembrolizumab plus chemotherapy.

10. TTD of lung cancer symptoms (Time Frame - Up to approximately 6 years):
To assess participant-reported pulmonary symptoms of mNSCLC in participants treated with volrustomig plus chemotherapy and pembrolizumab plus chemotherapy.

Studien-Arme

  • Experimental: Arm 1
    Volrustomig plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion
  • Active Comparator: Arm 2
    Pembrolizumab plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion

Geprüfte Regime

  • Volrustomig:
    Volrustomig
  • Pembrolizumab:
    Pembrolizumab
  • Carboplatin:
    Carboplatin
  • Paclitaxel:
    Paclitaxel
  • Pemetrexed:
    Pemetrexed

Quelle: ClinicalTrials.gov


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