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JOURNAL ONKOLOGIE – STUDIE

A Study of Ociperlimab With Tislelizumab Compared to Pembrolizumab in Participants With Untreated Lung Cancer

Rekrutierend

NCT-Nummer:
NCT04746924

Studienbeginn:
Juni 2021

Letztes Update:
04.03.2024

Wirkstoff:
Tislelizumab, Ociperlimab, Pembrolizumab, Placebo

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

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
BeiGene

Collaborator:
-

Studienleiter

Shun Lu
Principal Investigator
Shanghai Chest Hospital
Mark Socinski
Principal Investigator
Advent Health Orlando

Kontakt

Studienlocations
(3 von 103)

Helios Klinikum Bad Saarow
15526 Bad Saarow
(Brandenburg)
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Universitatsklinikum Bonn
53127 Bonn
(Nordrhein-Westfalen)
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Asklepios Fachklinik Munchen Gauting
82131 Gauting
(Bayern)
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Uniklinikum Giessen Marburg
35392 Giessen
(Hessen)
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Lungenclinic Grosshansdorf Gmbh
22927 Grobhansdorf
(Schleswig-Holstein)
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Ambulantes Krebszentrum Hamburg
20251 Hamburg
(Hamburg)
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Kliniken Der Stadt Koeln Ggmbh
51109 Koln
(Nordrhein-Westfalen)
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Klinikum Ludwigshafen, Medizinische Klinik A
67063 Ludwigshafen
(Rheinland-Pfalz)
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Munchen Klinik Bogenhausen
81925 Munich
(Bayern)
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Agaplesion Diakonieklinikum Rotenburg Gemeinnutzige Gmbh
27356 Rotenburg
(Niedersachsen)
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Onkologische Schwerpunkt Praxis Worms
67547 Worms
(Rheinland-Pfalz)
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Alaska Oncologyand Hematology, Llc
99508 Anchorage
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Providence Medical Foundation St Jude Heritage Healthcare
92835 Fullerton
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Valkyrie Clinical Trials
90067 Los Angeles
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Ocala Oncology Center Pl Dba Florida Cancer Affiliates Ocala
34474 Ocala
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Advent Health Cancer Institute
32804 Orlando
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Goshen Center For Cancer Care
46526 Goshen
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Baptist Health Lexington
40503 Lexington
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University Medical Center New Orleans West Jefferson Medical Center
70112 New Orleans
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Metro Minnesota Community Oncology Research Consortium (Mmcorc)
55101 Saint Paul
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Penn State Health Cancer Institute
17033 Hershey
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Virginia Cancer Specialists
22031 Fairfax
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Centro Medical Austral
1409 Buenos Aires
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Organizacion Medica de Investigacion Omi
1705 Buenos Aires
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Instituto de Oncologia de Rosario
S2000KZE Rosario
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Centro Para La Atencion Del Paciente Oncologico (Caipo)
4000 Tucuman
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Hospital de Amor Barretos
14784-400 Barretos
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Instituto Dor de Pesquisa E Ensino Distrito Federal
70390140 Brasilia
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Hospital Evangelico de Cachoeiro de Itapemirim
29308-020 Cachoeiro de Itapemirim
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Centro Integrado de Oncologia de Curitiba Ss Cionc
80810-050 Curitiba
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Centro de Pesquisas Oncologicas Cepon
88034-000 Florianopolis
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Cancer Institute of Ceara
60430-235 Fortaleza
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Oncosite Centro de Pesquisa Clinica Em Oncologia
98700-000 Ijui
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Clinica de Neoplasias Litoral
88301220 Itajai
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Hospital Sao Vicente de Paulo
99010-080 Passo Fundo
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Irmandade Da Santa Casa de Misericordia Hospital Porto Alegre
90020-090 Porto Alegre
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Hospital Moinhos de Vento
90035-000 Porto Alegre
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Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
90850-170 Porto Alegre
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76834-899 Porto Velho
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Instituto Dor de Pesquisa E Ensino Recife
52010030 Recife
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Oncoclinicas Rio de Janeiro Sa
22250-905 Rio de Janeiro
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Instituto Dor de Pesquisa E Ensino Rio de Janeiro
22281-100 Rio de Janeiro
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Nob Nucleo de Oncologia Da Bahia
40170-110 Salvador
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Cepho Centro de Estudos E Pesquisas de Hematologia E Oncologia
09060-650 Santo Andre
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Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
15090-000 Sao Jose do Rio Preto
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Notredame Intermedica Sa
01229-010 Sao Paulo
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Nucleo de Pesquisa Da Rede Sao Camilo (Instituto Brasileiro de Controle Do Cancer)
04014-002 Sao Paulo
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Centre Hospitalier de La Cote Basque Saint Leon Service de Pneumologie
64100 Bayonne
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Centre de Lutte Contre Le Cancer Institut Bergonie
33076 Bordeaux
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Icm Val Daurelle Oncologie Medicale
24298 Montpellier
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Chu Reunion Site Felix Guyon
97400 Saint Denis
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Centre de Lutte Contre Le Cancer Institut de Cancerologie de Louest Rene Gauducheau
44805 SaintHerblain
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Chu Nantes Hopital Nord Laennec
44805 SaintHerblain
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Chu Tours Hopital Bretonneau Service Pneumologie
37000 Tours
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Hirosaki University Hospital
036-8563 Hirosaki
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Nho Shikoku Cancer Center
791-0280 Matsuyamashi
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National Hospital Organization Shibukawa Medical Center
337-0280 Shibukawa
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Hokkaido University Hospital
060-8648 Sapporoshi
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Hyogo Prefectural Amagasaki General Medical Center
660-8550 AmagasakiCity
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Kobe City Medical Center General Hospital
650-0047 Kobe
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Hyogo Medical University Hospital
663-8501 Nishinomiyashi
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Kanazawa University Hospital
920-8641 Kanazawa
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Yokohama Municipal Citizens Hospital
2408555 Yokohama
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Okayama University Hospital
700-8558 Okayamashi
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Kansai Medical University Hospital
573-1191 Hirakata
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Kindai University Hospital
589-8511 Osakasayama
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National Hospital Organization Kinki Chuo Chest Medical Center
591-8555 Sakai
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Osaka Toneyama Medical Center
560-8552 Toyonaka
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Jichi Medical University Hospital
329-0498 Shimonotsuke
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Dokkyo Medical University Hospital
321-0293 Shimotsugagun
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Nippon Medical School Hospital
113-8603 Bunkyoku
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Japan Anti Tuberculosis Association Fukujuji Hospital
204-8522 Kiyoseshi
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Cancer Institute Hospital of Jfcr
135-8550 Kotoku
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Showa University Hospital
142-8666 Shinagawaku
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Hiroshima University Hospital
734-8551 Hiroshima
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Niigata Cancer Center Hospital
951-8566 Niigata
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Keimyung University Dongsan Hospital
42601 Dalseogu
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The Catholic University of Korea, St Vincents Hospital
16247 Suwonsi
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The Catholic University of Korea, Eunpyeong St Marys Hospital
03312 Eunpyeonggu
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Health Pharma Professional Research Sa de Cv
03100 Ciudad de Mexico
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Preparaciones Oncologicas Sc
37178 Ciudad Leon
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Christus Latam Hub Center of Excellence and Innovation Sc
64000 Monterrey
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Centro de Investigacion Clinica de Oaxaca
68020 Oaxaca
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Antalya Memorial Hospital
07025 Antalya Memorial Hospital
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Alle anzeigen

Studien-Informationen

Brief Summary:

The purpose of this study is to evaluate the efficacy and safety of ociperlimab +

tislelizumab compared with that of pembrolizumab in adults with PD-L1 high, locally

advanced/recurrent or untreated metastatic NSCLC.

Ein-/Ausschlusskriterien

Key Inclusion Criteria:

1. Histologically or cytologically documented locally advanced or recurrent non-small

cell lung cancer (NSCLC) that is not eligible for curative surgery and/or definitive

radiotherapy with or without chemoradiotherapy, or metastatic-nonsquamous or squamous

NSCLC.

2. No prior systemic treatment for metastatic NSCLC.

3. Agreement to provide archival tissue or fresh biopsy (if archival tissue is not

available).

4. Tumors with PD-L1 expressed in ≥ 50% tumor cells.

5. At least 1 measurable lesion as defined per RECIST v1.1.

6. ECOG Performance Status ≤ 1.

Key Exclusion Criteria:

1. Known mutations in the epidermal growth factor receptor (EGFR) gene, anaplastic

lymphoma kinase (ALK) fusion oncogene, BRAF V600E, or ROS1.

2. Prior therapy with an anti-programmed cell death protein (anti-PD)-1, anti-PD-ligand

(L)-1, anti-PD-ligand-2, anti-T-cell immunoglobulin and ITIM (anti-TIGIT) domain, or

any other antibody or drug specifically targeting T-cell costimulation or checkpoint

pathways.

3. Active leptomeningeal disease or uncontrolled, untreated brain metastasis.

4. Active autoimmune diseases or history of autoimmune diseases that may relapse.

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Studien-Rationale

Primary outcome:

1. Overall Survival (OS) (Time Frame - Up to approximately 58 months):
OS will be defined as the time from the date of randomization to the date of death due to any cause.



Secondary outcome:

1. Progression-free Survival (PFS) As Assessed By Investigators (Time Frame - Up to approximately 58 months):
PFS will be defined as the time from the date of randomization to the date of the first objectively documented tumor progression per RECIST v1.1, or death, whichever occurs first.

2. Overall Response Rate (ORR) As Assessed By Investigators (Time Frame - Up to approximately 58 months):
ORR will be defined as the proportion of participants with a documented, confirmed complete response or partial response per RECIST v1.1.

3. Duration Of Response (DOR) As Assessed By Investigators (Time Frame - Up to approximately 58 months):
DOR will be defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of progression or death, whichever occurs first.

4. Health-related Quality Of Life (HRQoL): European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire Core 30 (EORTC QLQ-C30) (Time Frame - Within 7 days after permanent treatment discontinuation):
HRQoL will be assessed via patient-reported outcomes (PRO) using the EORTC QLQ-C30. The EORTC QLQ-C30 (Version 3) consists of Global health status/QoL (score range from 0=very poor to 7=excellent), 5 functioning scales (physical, role, emotional, cognitive, social), 8 symptom scales (fatigue, nausea/vomiting, pain, dyspnea, insomnia, constipation, diarrhea) and financial difficulties with scores ranging from 1 = "Not at all" to 4 = "Very much". For the global health status/QoL and functioning scales, higher scores indicate better outcomes and for symptom scales, lower scores indicate better outcomes.

5. HRQoL: EORTC Lung Cancer Module Quality of Life Questionnaire Lung Cancer 13 (QLQ-LC13) HRQoL will be assessed via PRO using the EORTC QLQ-LC13. (Time Frame - Within 7 days after permanent treatment discontinuation):
QLQ-LC13 consists of 10 scales, scores ranging from 1 = "not at all" to 4 = "very much", and 2 questions regarding use of pain medication (yes/no) and if yes, did it help (1 = "not at all" to 4 = "very much"). In symptom scales, lower scores indicate better outcomes.

6. HRQoL: European Quality of Life-5 Level- 5 Dimension (EQ-5D-5L) Questionnaire (Time Frame - Within 7 days after permanent treatment discontinuation):
HRQoL will be assessed via PRO using the EQ-5D-5L. The EQ-5D-5L comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, and a visual analog scale (VAS). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The VAS records the respondent's self-rated health on a 0 to 100 scale, with 100 = "the best health you can imagine" and 0 = "'the worst health you can imagine". Lower scores in descriptive dimension indicate better HRQoL and higher VAS scores indicates better health state.

7. Time To Deterioration (TTD) (Time Frame - Within 7 days after permanent treatment discontinuation):
TTD will be analyzed using PRO scores, and will be defined as worsening scores of ≥10 points from baseline for 2 consecutive assessments or 1 assessment followed by death from any cause.

8. Number Of Participants Experiencing Adverse Events (AEs) (Time Frame - 90 days (±14) after last dose):
The incidence and severity of AEs will be determined according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0).

Studien-Arme

  • Experimental: Arm A: Tislelizumab plus Ociperlimab
    Participants will receive tislelizumab 200 milligrams (mg) intravenously followed by ociperlimab 900 mg intravenously once every 3 weeks.
  • Active Comparator: Arm B: Pembrolizumab plus Placebo
    Participants will receive pembrolizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks.
  • Placebo Comparator: Arm C: Tislelizumab plus Placebo
    Participants will receive tislelizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks.

Geprüfte Regime

  • Tislelizumab (BGB-A317):
    Tislelizumab is a monoclonal antibody formulated for intravenous injection.
  • Ociperlimab (BGB-A1217):
    Ociperlimab is a monoclonal antibody formulated for intravenous injection.
  • Pembrolizumab (KEYTRUDA):
    Pembrolizumab is a monoclonal antibody formulated for intravenous injection.
  • Placebo:
    Placebo infusions will consist of a sterile, normal saline solution.

Quelle: ClinicalTrials.gov


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"A Study of Ociperlimab With Tislelizumab Compared to Pembrolizumab in Participants With Untreated Lung Cancer"

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