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

Primary Purpose

Non-small Cell Lung Cancer, NSCLC

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tislelizumab
Ociperlimab
Pembrolizumab
Placebo
Sponsored by
BeiGene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Locally Advanced, Unresectable, Metastatic, Tislelizumab, BGB-A317, Ociperlimab, BGB-A1217, Pembrolizumab, Anti-TIGIT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alaska Oncologyand Hematology, LlcRecruiting
  • Providence Medical Foundation St Jude Heritage HealthcareRecruiting
  • Valkyrie Clinical TrialsRecruiting
  • Ocala Oncology Center Pl Dba Florida Cancer Affiliates OcalaRecruiting
  • Advent Health Cancer InstituteRecruiting
  • Goshen Center For Cancer CareRecruiting
  • Baptist Health LexingtonRecruiting
  • University Medical Center New Orleans West Jefferson Medical CenterRecruiting
  • Metro Minnesota Community Oncology Research Consortium (Mmcorc)Recruiting
  • Penn State Health Cancer InstituteRecruiting
  • West Penn HospitalRecruiting
  • Virginia Cancer SpecialistsRecruiting
  • Hospital Moinhos de VentoRecruiting
  • Cepho Centro de Estudos E Pesquisas de Hematologia E OncologiaRecruiting
  • Centre Hospitalier de La Cote Basque Saint Leon Service de PneumologieRecruiting
  • Centre de Lutte Contre Le Cancer Institut BergonieRecruiting
  • Chi CreteilRecruiting
  • Chu MartiniqueRecruiting
  • Hopital de La Croix RousseRecruiting
  • Hopital Louis PradelRecruiting
  • Icm Val Daurelle Oncologie MedicaleRecruiting
  • Polyclinique de GentillyRecruiting
  • Hopital CochinRecruiting
  • Chu Hopital Lyon SudRecruiting
  • Chu Reunion Site Felix GuyonRecruiting
  • Hia BeginRecruiting
  • Chu de La ReunionRecruiting
  • Centre de Lutte Contre Le Cancer Institut de Cancerologie de Louest Rene GauducheauRecruiting
  • Chu Nantes Hopital Nord LaennecRecruiting
  • Chu Tours Hopital Bretonneau Service PneumologieRecruiting
  • Universitaetsklinikum AachenRecruiting
  • Helios Klinikum Bad SaarowRecruiting
  • Universitatsklinikum BonnRecruiting
  • Asklepios Fachklinik Munchen GautingRecruiting
  • Uniklinikum Giessen MarburgRecruiting
  • Lungenclinic Grosshansdorf GmbhRecruiting
  • Ambulantes Krebszentrum HamburgRecruiting
  • Kliniken Der Stadt Koeln GgmbhRecruiting
  • Klinikum Ludwigshafen, Medizinische Klinik ARecruiting
  • Munchen Klinik BogenhausenRecruiting
  • Agaplesion Diakonieklinikum Rotenburg Gemeinnutzige GmbhRecruiting
  • Onkologische Schwerpunkt Praxis WormsRecruiting
  • Cro Irccs AvianoRecruiting
  • Azienda Ospedaliera Universitaria Policlinico Santorsola MalpighiRecruiting
  • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IrstRecruiting
  • Azienda Ospedaliera PapardoRecruiting
  • Ospedale San RaffaeleRecruiting
  • Aou San Luigi GonzagaRecruiting
  • Azienda Ospedaliera Universitaria Integrata Di VeronaRecruiting
  • Nagoya University HospitalRecruiting
  • Hirosaki University HospitalRecruiting
  • Nho Shikoku Cancer CenterRecruiting
  • Kurume University HospitalRecruiting
  • National Hospital Organization Shibukawa Medical CenterRecruiting
  • Hokkaido University HospitalRecruiting
  • Hyogo Prefectural Amagasaki General Medical CenterRecruiting
  • Kobe City Medical Center General HospitalRecruiting
  • Hyogo Medical University HospitalRecruiting
  • Kanazawa University HospitalRecruiting
  • Kanagawa Cancer CenterRecruiting
  • Yokohama Municipal Citizens HospitalRecruiting
  • Miyagi Cancer CenterRecruiting
  • Nagaoka Red Cross HospitalRecruiting
  • Okayama University HospitalRecruiting
  • Kansai Medical University HospitalRecruiting
  • Kindai University HospitalRecruiting
  • National Hospital Organization Kinki Chuo Chest Medical CenterRecruiting
  • Osaka Toneyama Medical CenterRecruiting
  • Jichi Medical University HospitalRecruiting
  • Dokkyo Medical University HospitalRecruiting
  • Tochigi Cancer CenterRecruiting
  • Nippon Medical School HospitalRecruiting
  • Japan Anti Tuberculosis Association Fukujuji HospitalRecruiting
  • Cancer Institute Hospital of JfcrRecruiting
  • Showa University HospitalRecruiting
  • Hiroshima University HospitalRecruiting
  • Niigata Cancer Center HospitalRecruiting
  • Inje University Haeundae Paik HospitalRecruiting
  • Chungbuk National University HospitalRecruiting
  • Keimyung University Dongsan HospitalRecruiting
  • The Catholic University of Korea, St Vincents HospitalRecruiting
  • Kyungpook National University Chilgok HospitalRecruiting
  • The Catholic University of Korea, Eunpyeong St Marys HospitalRecruiting
  • Severance Hospital Yonsei University Health SystemRecruiting
  • Cha Bundang Medical Center, Cha UniversityRecruiting
  • Uniwersytecki Szpital Kliniczny W BialymstokuRecruiting
  • Szpitale Pomorskie Spolka Z Ograniczona OdpowiedzialnosciaRecruiting
  • Centrum Terapii WspoczesnejRecruiting
  • Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W LodziRecruiting
  • Wielkopolskie Centrum Pulmonologii I TorakochirurgiiRecruiting
  • Przychodnia Med Polonia Sp Z OoRecruiting
  • Etg ZamoscRecruiting
  • Hospital Universitario Fundacion AlcorconRecruiting
  • Hospital Del MarRecruiting
  • Hospital de La Santa Creu I Sant PauRecruiting
  • Hospital Universitario Vall DhebronRecruiting
  • Ico Hug Trias I PujolRecruiting
  • Hospital Universitari Quiron DexeusRecruiting
  • Hospital Universitario DonostiaRecruiting
  • Hospital General Universitario de ElcheRecruiting
  • Ico GironaRecruiting
  • Hospital Universitario de JaenRecruiting
  • Complejo Hospitalario Universitario Insular Gran CanariaRecruiting
  • Hospital Universitario Lucus AugustiRecruiting
  • Hospital Clinico San CarlosRecruiting
  • Start Madrid Fundacion Jimenez DiazRecruiting
  • Hospital Universitario Doce de OctubreRecruiting
  • Hospital Universitario La PazRecruiting
  • Hospital Universitario Puerta de Hierro MajadahondaRecruiting
  • Hospital Regional Universitario de MalagaRecruiting
  • Hospital Universitario Virgen de La VictoriaRecruiting
  • Hospital General Universitario Morales MeseguerRecruiting
  • Complexo Hospitalario Universitario de OurenseRecruiting
  • Hospital Universitari Son EspasesRecruiting
  • Hospital Universitario Virgen Del RocioRecruiting
  • Hospital Universitario Nuestra Senora de ValmeRecruiting
  • Consorcio Hospital General Universitario de ValenciaRecruiting
  • Hospital Arnau de VilanovaRecruiting
  • Hospital Universitari I Politecnic La FeRecruiting
  • Acibadem Adana HospitalRecruiting
  • Baskent University Practice and Research Hospital Adana Medical Oncology DepartmentRecruiting
  • Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalRecruiting
  • Memorial Ankara HospitalRecruiting
  • Antalya Memorial HospitalRecruiting
  • Nonu Universitesi Tip FakultesiRecruiting
  • Tr Trakya University Health Research and Application Center (Hospital)Recruiting
  • Tr Ministry of Health Goztepe Prof Dr Suleyman Yalcin City HospitalRecruiting
  • Ege University Medical FacultyRecruiting
  • Kocaeli Universitesi Tip FakultesiRecruiting
  • Necmettin Erbakan University Selcuklu Faculty of MedicineRecruiting
  • Mersin City HospitalRecruiting
  • Iu C, Clinical Research Excellence Application and Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Arm A: Tislelizumab plus Ociperlimab

Arm B: Pembrolizumab plus Placebo

Arm C: Tislelizumab plus Placebo

Arm Description

Participants will receive tislelizumab 200 milligrams (mg) intravenously followed by ociperlimab 900 mg intravenously once every 3 weeks.

Participants will receive pembrolizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks.

Participants will receive tislelizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks.

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS) As Assessed By Investigators
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.
Overall Survival (OS)
OS will be defined as the time from the date of randomization to the date of death due to any cause.

Secondary Outcome Measures

PFS As Assessed By A Blinded Independent Review Committee
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.
Overall Response Rate (ORR) As Assessed By Investigators
ORR will be defined as the proportion of participants with a documented, confirmed complete response or partial response per RECIST v1.1.
Duration Of Response (DOR) As Assessed By Investigators
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.
Health-related Quality Of Life (HRQoL): European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire Core 30 (EORTC QLQ-C30)
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.
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.
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.
HRQoL: European Quality of Life-5 Level- 5 Dimension (EQ-5D-5L) Questionnaire
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.
Time To Deterioration (TTD)
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.
Number Of Participants Experiencing Adverse Events (AEs)
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).

Full Information

First Posted
February 5, 2021
Last Updated
September 20, 2023
Sponsor
BeiGene
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1. Study Identification

Unique Protocol Identification Number
NCT04746924
Brief Title
A Study of Ociperlimab With Tislelizumab Compared to Pembrolizumab in Participants With Untreated Lung Cancer
Official Title
A Phase 3, Randomized, Double-Blind Study of Ociperlimab, an Anti-TIGIT Antibody, in Combination With Tislelizumab Compared to Pembrolizumab in Patients With Previously Untreated, PD-L1-Selected, and Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 8, 2021 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiGene

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to compare progression-free survival (PFS) between Arm A (ociperlimab in combination with tislelizumab) and Arm B (pembrolizumab in combination with placebo) as assessed by investigators according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) and to compare overall survival (OS) between Arm A and Arm B.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer, NSCLC
Keywords
Locally Advanced, Unresectable, Metastatic, Tislelizumab, BGB-A317, Ociperlimab, BGB-A1217, Pembrolizumab, Anti-TIGIT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
660 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Tislelizumab plus Ociperlimab
Arm Type
Experimental
Arm Description
Participants will receive tislelizumab 200 milligrams (mg) intravenously followed by ociperlimab 900 mg intravenously once every 3 weeks.
Arm Title
Arm B: Pembrolizumab plus Placebo
Arm Type
Active Comparator
Arm Description
Participants will receive pembrolizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks.
Arm Title
Arm C: Tislelizumab plus Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive tislelizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Other Intervention Name(s)
BGB-A317
Intervention Description
Tislelizumab is a monoclonal antibody formulated for intravenous injection.
Intervention Type
Drug
Intervention Name(s)
Ociperlimab
Other Intervention Name(s)
BGB-A1217
Intervention Description
Ociperlimab is a monoclonal antibody formulated for intravenous injection.
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
KEYTRUDA
Intervention Description
Pembrolizumab is a monoclonal antibody formulated for intravenous injection.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo infusions will consist of a sterile, normal saline solution.
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS) As Assessed By Investigators
Description
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.
Time Frame
Up to approximately 40 months
Title
Overall Survival (OS)
Description
OS will be defined as the time from the date of randomization to the date of death due to any cause.
Time Frame
Up to approximately 40 months
Secondary Outcome Measure Information:
Title
PFS As Assessed By A Blinded Independent Review Committee
Description
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.
Time Frame
Up to approximately 40 months
Title
Overall Response Rate (ORR) As Assessed By Investigators
Description
ORR will be defined as the proportion of participants with a documented, confirmed complete response or partial response per RECIST v1.1.
Time Frame
Up to approximately 40 months
Title
Duration Of Response (DOR) As Assessed By Investigators
Description
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.
Time Frame
Up to approximately 40 months
Title
Health-related Quality Of Life (HRQoL): European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire Core 30 (EORTC QLQ-C30)
Description
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.
Time Frame
Within 7 days after permanent treatment discontinuation
Title
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.
Description
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.
Time Frame
Within 7 days after permanent treatment discontinuation
Title
HRQoL: European Quality of Life-5 Level- 5 Dimension (EQ-5D-5L) Questionnaire
Description
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.
Time Frame
Within 7 days after permanent treatment discontinuation
Title
Time To Deterioration (TTD)
Description
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.
Time Frame
Within 7 days after permanent treatment discontinuation
Title
Number Of Participants Experiencing Adverse Events (AEs)
Description
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).
Time Frame
90 days (±14) after last dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: 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. No prior systemic treatment for metastatic NSCLC. Agreement to provide archival tissue or fresh biopsy (if archival tissue is not available). Tumors with PD-L1 expressed in ≥ 50% tumor cells. At least 1 measurable lesion as defined per RECIST v1.1. ECOG Performance Status ≤ 1. Key Exclusion Criteria: Known mutations in the epidermal growth factor receptor (EGFR) gene, anaplastic lymphoma kinase (ALK) fusion oncogene, BRAF V600E, or ROS1. 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. Active leptomeningeal disease or uncontrolled, untreated brain metastasis. Active autoimmune diseases or history of autoimmune diseases that may relapse. Note: Other protocol defined Inclusion/Exclusion criteria may apply
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BeiGene
Phone
1-877-828-5568
Email
clinicaltrials@beigene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shun Lu
Organizational Affiliation
Shanghai Chest Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Socinski
Organizational Affiliation
Advent Health Orlando
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alaska Oncologyand Hematology, Llc
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Individual Site Status
Recruiting
Facility Name
Providence Medical Foundation St Jude Heritage Healthcare
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Individual Site Status
Recruiting
Facility Name
Valkyrie Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90067
Country
United States
Individual Site Status
Recruiting
Facility Name
Ocala Oncology Center Pl Dba Florida Cancer Affiliates Ocala
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Individual Site Status
Recruiting
Facility Name
Advent Health Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Individual Site Status
Recruiting
Facility Name
Goshen Center For Cancer Care
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Individual Site Status
Recruiting
Facility Name
Baptist Health Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Individual Site Status
Recruiting
Facility Name
University Medical Center New Orleans West Jefferson Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Name
Metro Minnesota Community Oncology Research Consortium (Mmcorc)
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Individual Site Status
Recruiting
Facility Name
Penn State Health Cancer Institute
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Name
West Penn Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Recruiting
Facility Name
Virginia Cancer Specialists
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Name
Hospital Moinhos de Vento
City
Porto Alegre
ZIP/Postal Code
90035-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Cepho Centro de Estudos E Pesquisas de Hematologia E Oncologia
City
Santo Andre
ZIP/Postal Code
09060-650
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier de La Cote Basque Saint Leon Service de Pneumologie
City
Bayonne
ZIP/Postal Code
64100
Country
France
Individual Site Status
Recruiting
Facility Name
Centre de Lutte Contre Le Cancer Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Name
Chi Creteil
City
Creteil
ZIP/Postal Code
94000
Country
France
Individual Site Status
Recruiting
Facility Name
Chu Martinique
City
Fort De France
ZIP/Postal Code
97261
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital de La Croix Rousse
City
Lyon
ZIP/Postal Code
69317
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Louis Pradel
City
Lyon
ZIP/Postal Code
69500
Country
France
Individual Site Status
Recruiting
Facility Name
Icm Val Daurelle Oncologie Medicale
City
Montpellier
ZIP/Postal Code
24298
Country
France
Individual Site Status
Recruiting
Facility Name
Polyclinique de Gentilly
City
Nancy
ZIP/Postal Code
54100
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Cochin
City
Paris cedex
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Name
Chu Hopital Lyon Sud
City
PierreBenite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Name
Chu Reunion Site Felix Guyon
City
Saint Denis
ZIP/Postal Code
97400
Country
France
Individual Site Status
Recruiting
Facility Name
Hia Begin
City
saint Mande
ZIP/Postal Code
94160
Country
France
Individual Site Status
Recruiting
Facility Name
Chu de La Reunion
City
Saint Pierre
ZIP/Postal Code
97448
Country
France
Individual Site Status
Recruiting
Facility Name
Centre de Lutte Contre Le Cancer Institut de Cancerologie de Louest Rene Gauducheau
City
SaintHerblain
ZIP/Postal Code
44805
Country
France
Individual Site Status
Recruiting
Facility Name
Chu Nantes Hopital Nord Laennec
City
SaintHerblain
ZIP/Postal Code
44805
Country
France
Individual Site Status
Recruiting
Facility Name
Chu Tours Hopital Bretonneau Service Pneumologie
City
Tours
ZIP/Postal Code
37000
Country
France
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Individual Site Status
Recruiting
Facility Name
Helios Klinikum Bad Saarow
City
Bad Saarow
ZIP/Postal Code
15526
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitatsklinikum Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Individual Site Status
Recruiting
Facility Name
Asklepios Fachklinik Munchen Gauting
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Individual Site Status
Recruiting
Facility Name
Uniklinikum Giessen Marburg
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Individual Site Status
Recruiting
Facility Name
Lungenclinic Grosshansdorf Gmbh
City
Grobhansdorf
ZIP/Postal Code
22927
Country
Germany
Individual Site Status
Recruiting
Facility Name
Ambulantes Krebszentrum Hamburg
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Individual Site Status
Recruiting
Facility Name
Kliniken Der Stadt Koeln Ggmbh
City
Koln
ZIP/Postal Code
51109
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum Ludwigshafen, Medizinische Klinik A
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Individual Site Status
Recruiting
Facility Name
Munchen Klinik Bogenhausen
City
Munich
ZIP/Postal Code
81925
Country
Germany
Individual Site Status
Recruiting
Facility Name
Agaplesion Diakonieklinikum Rotenburg Gemeinnutzige Gmbh
City
Rotenburg
ZIP/Postal Code
27356
Country
Germany
Individual Site Status
Recruiting
Facility Name
Onkologische Schwerpunkt Praxis Worms
City
Worms
ZIP/Postal Code
67547
Country
Germany
Individual Site Status
Recruiting
Facility Name
Cro Irccs Aviano
City
Aviano
ZIP/Postal Code
33081
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Papardo
City
Messina
ZIP/Postal Code
98158
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Aou San Luigi Gonzaga
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Integrata Di Verona
City
Verona
ZIP/Postal Code
37126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Nagoya University Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hirosaki University Hospital
City
Hirosaki
State/Province
Aomori
ZIP/Postal Code
036-8563
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nho Shikoku Cancer Center
City
Matsuyamashi
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kurume University Hospital
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Shibukawa Medical Center
City
Shibukawa
State/Province
Gunma
ZIP/Postal Code
337-0280
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hokkaido University Hospital
City
Sapporoshi
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hyogo Prefectural Amagasaki General Medical Center
City
AmagasakiCity
State/Province
Hyogo
ZIP/Postal Code
660-8550
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kobe City Medical Center General Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hyogo Medical University Hospital
City
Nishinomiyashi
State/Province
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kanazawa University Hospital
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kanagawa Cancer Center
City
Yokohamashi
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yokohama Municipal Citizens Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
2408555
Country
Japan
Individual Site Status
Recruiting
Facility Name
Miyagi Cancer Center
City
Natorishi
State/Province
Miyagi
ZIP/Postal Code
981-1293
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nagaoka Red Cross Hospital
City
Nagaoka
State/Province
Niigata
ZIP/Postal Code
940-2085
Country
Japan
Individual Site Status
Recruiting
Facility Name
Okayama University Hospital
City
Okayamashi
State/Province
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kansai Medical University Hospital
City
Hirakata
State/Province
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kindai University Hospital
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Kinki Chuo Chest Medical Center
City
Sakai
State/Province
Osaka
ZIP/Postal Code
591-8555
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka Toneyama Medical Center
City
Toyonaka
State/Province
Osaka
ZIP/Postal Code
560-8552
Country
Japan
Individual Site Status
Recruiting
Facility Name
Jichi Medical University Hospital
City
Shimonotsuke
State/Province
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
Individual Site Status
Recruiting
Facility Name
Dokkyo Medical University Hospital
City
Shimotsugagun
State/Province
Tochigi
ZIP/Postal Code
321-0293
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tochigi Cancer Center
City
Utsunomiya
State/Province
Tochigi
ZIP/Postal Code
320-0834
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nippon Medical School Hospital
City
Bunkyoku
State/Province
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Individual Site Status
Recruiting
Facility Name
Japan Anti Tuberculosis Association Fukujuji Hospital
City
Kiyoseshi
State/Province
Tokyo
ZIP/Postal Code
204-8522
Country
Japan
Individual Site Status
Recruiting
Facility Name
Cancer Institute Hospital of Jfcr
City
Kotoku
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Recruiting
Facility Name
Showa University Hospital
City
Shinagawaku
State/Province
Tokyo
ZIP/Postal Code
142-8666
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hiroshima University Hospital
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Individual Site Status
Recruiting
Facility Name
Niigata Cancer Center Hospital
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Individual Site Status
Recruiting
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
State/Province
Busan Gwang'yeogsi
ZIP/Postal Code
48108
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Chungbuk National University Hospital
City
Cheongjusi
State/Province
Chungcheongbukdo
ZIP/Postal Code
28644
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Keimyung University Dongsan Hospital
City
Dalseogu
State/Province
Daegu Gwang'yeogsi
ZIP/Postal Code
42601
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea, St Vincents Hospital
City
Suwonsi
State/Province
Gyeonggido
ZIP/Postal Code
16247
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
State/Province
Gyeongsangbukdo
ZIP/Postal Code
41404
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea, Eunpyeong St Marys Hospital
City
Eunpyeonggu
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03312
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital Yonsei University Health System
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Cha Bundang Medical Center, Cha University
City
Gyeonggido
ZIP/Postal Code
13496
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Uniwersytecki Szpital Kliniczny W Bialymstoku
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Individual Site Status
Recruiting
Facility Name
Szpitale Pomorskie Spolka Z Ograniczona Odpowiedzialnoscia
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Terapii Wspoczesnej
City
Lodz
ZIP/Postal Code
90-338
Country
Poland
Individual Site Status
Recruiting
Facility Name
Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
City
Lodz
ZIP/Postal Code
93-510
Country
Poland
Individual Site Status
Recruiting
Facility Name
Wielkopolskie Centrum Pulmonologii I Torakochirurgii
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Individual Site Status
Recruiting
Facility Name
Przychodnia Med Polonia Sp Z Oo
City
Poznan
ZIP/Postal Code
60-693
Country
Poland
Individual Site Status
Recruiting
Facility Name
Etg Zamosc
City
Zamosc
ZIP/Postal Code
22-400
Country
Poland
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Fundacion Alcorcon
City
Alcorcon
ZIP/Postal Code
28922
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital de La Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Vall Dhebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Ico Hug Trias I Pujol
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Quiron Dexeus
City
Barcelona
ZIP/Postal Code
8028
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Donostia
City
Donostia
ZIP/Postal Code
20014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario de Elche
City
Elche
ZIP/Postal Code
3203
Country
Spain
Individual Site Status
Recruiting
Facility Name
Ico Girona
City
Girona
ZIP/Postal Code
17007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de Jaen
City
Jaen
ZIP/Postal Code
23007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Complejo Hospitalario Universitario Insular Gran Canaria
City
Las Palmas
ZIP/Postal Code
35016
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Lucus Augusti
City
Lugo
ZIP/Postal Code
27003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Start Madrid Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Doce de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Regional Universitario de Malaga
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen de La Victoria
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario Morales Meseguer
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Complexo Hospitalario Universitario de Ourense
City
Orense
ZIP/Postal Code
32005
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Son Espases
City
Palma de Mallorca
ZIP/Postal Code
07120
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen Del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Nuestra Senora de Valme
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Consorcio Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Arnau de Vilanova
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari I Politecnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Acibadem Adana Hospital
City
Adana
ZIP/Postal Code
01130
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Baskent University Practice and Research Hospital Adana Medical Oncology Department
City
Adana
ZIP/Postal Code
1240
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
City
Ankara Oncology Abdurrahman Yurtaslan Hospital
ZIP/Postal Code
06200
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Memorial Ankara Hospital
City
Ankara
ZIP/Postal Code
6520
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Antalya Memorial Hospital
City
Antalya Memorial Hospital
ZIP/Postal Code
07025
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Nonu Universitesi Tip Fakultesi
City
Battalgazi
ZIP/Postal Code
44280
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Tr Trakya University Health Research and Application Center (Hospital)
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Tr Ministry of Health Goztepe Prof Dr Suleyman Yalcin City Hospital
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ege University Medical Faculty
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Kocaeli Universitesi Tip Fakultesi
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Necmettin Erbakan University Selcuklu Faculty of Medicine
City
Meram
ZIP/Postal Code
42090
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Mersin City Hospital
City
Mersin City Hospital
ZIP/Postal Code
33240
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Iu C, Clinical Research Excellence Application and Research Center
City
Stanbul
ZIP/Postal Code
34098
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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