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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04746924




Registration number
NCT04746924
Ethics application status
Date submitted
5/02/2021
Date registered
10/02/2021

Titles & IDs
Public title
A Study of Ociperlimab With Tislelizumab Compared to Pembrolizumab in Participants With Untreated Lung Cancer
Scientific 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
Secondary ID [1] 0 0
BGB-A317-A1217-302
Secondary ID [2] 0 0
AdvanTIG-302
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer 0 0
NSCLC 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tislelizumab
Treatment: Drugs - Ociperlimab
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Placebo

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.


Treatment: Drugs: Tislelizumab
Tislelizumab is a monoclonal antibody formulated for intravenous injection.

Treatment: Drugs: Ociperlimab
Ociperlimab is a monoclonal antibody formulated for intravenous injection.

Treatment: Drugs: Pembrolizumab
Pembrolizumab is a monoclonal antibody formulated for intravenous injection.

Treatment: Drugs: Placebo
Placebo infusions will consist of a sterile, normal saline solution.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to approximately 58 months
Secondary outcome [1] 0 0
Progression-free Survival (PFS) As Assessed By Investigators
Timepoint [1] 0 0
Up to approximately 58 months
Secondary outcome [2] 0 0
Overall Response Rate (ORR) As Assessed By Investigators
Timepoint [2] 0 0
Up to approximately 58 months
Secondary outcome [3] 0 0
Duration Of Response (DOR) As Assessed By Investigators
Timepoint [3] 0 0
Up to approximately 58 months
Secondary outcome [4] 0 0
Health-related Quality Of Life (HRQoL): European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire Core 30 (EORTC QLQ-C30)
Timepoint [4] 0 0
Within 7 days after permanent treatment discontinuation
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
Within 7 days after permanent treatment discontinuation
Secondary outcome [6] 0 0
HRQoL: European Quality of Life-5 Level- 5 Dimension (EQ-5D-5L) Questionnaire
Timepoint [6] 0 0
Within 7 days after permanent treatment discontinuation
Secondary outcome [7] 0 0
Time To Deterioration (TTD)
Timepoint [7] 0 0
Within 7 days after permanent treatment discontinuation
Secondary outcome [8] 0 0
Number Of Participants Experiencing Adverse Events (AEs)
Timepoint [8] 0 0
90 days (±14) after last dose

Eligibility
Key inclusion criteria
Key

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
7/02/2027
Actual
Sample size
Target
Accrual to date
Final
662
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Pindara Private Hospital - Benowa
Recruitment hospital [2] 0 0
Mater Cancer Care Centre - South Brisbane
Recruitment hospital [3] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [4] 0 0
Ballarat Health Services - Ballarat
Recruitment hospital [5] 0 0
Monash Health - Clayton
Recruitment hospital [6] 0 0
Western Health Sunshine Hospital - St Albans
Recruitment hospital [7] 0 0
St John of God, Murdoch - Murdoch
Recruitment postcode(s) [1] 0 0
4217 - Benowa
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [4] 0 0
3350 - Ballarat
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment postcode(s) [6] 0 0
3021 - St Albans
Recruitment postcode(s) [7] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
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Florida
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United States of America
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Indiana
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United States of America
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Kentucky
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United States of America
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Louisiana
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United States of America
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Minnesota
Country [7] 0 0
United States of America
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Pennsylvania
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Argentina
State/province [8] 0 0
Tucuman
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Brazil
State/province [9] 0 0
Brasilia
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Brazil
State/province [10] 0 0
Cachoeiro de Itapemirim
Country [11] 0 0
Brazil
State/province [11] 0 0
Florianopolis
Country [12] 0 0
Brazil
State/province [12] 0 0
Sao Jose do Rio Preto
Country [13] 0 0
China
State/province [13] 0 0
Anhui
Country [14] 0 0
China
State/province [14] 0 0
Beijing
Country [15] 0 0
China
State/province [15] 0 0
Chongqing
Country [16] 0 0
China
State/province [16] 0 0
Fujian
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China
State/province [17] 0 0
Guangdong
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China
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Guangxi
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China
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Heilongjiang
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China
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Henan
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China
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Hubei
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China
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Hunan
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China
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Jiangsu
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China
State/province [24] 0 0
Liaoning
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China
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Shaanxi
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China
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Shandong
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China
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Shanghai
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China
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Shanxi
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China
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Sichuan
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China
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Tianjin
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China
State/province [31] 0 0
Xinjiang
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China
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Zhejiang
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France
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Bayonne
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France
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Bordeaux
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France
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Lyon
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France
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Montpellier
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France
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Nancy
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France
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Paris cedex
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saint Mande
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Saint Pierre
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France
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SaintHerblain
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France
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Tours
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Georgia
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Batumi
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Georgia
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Tbilisi
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Germany
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Aachen
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Germany
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Bonn
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Germany
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Giessen
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Germany
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Grobhansdorf
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Germany
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Hamburg
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Germany
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Koln
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Germany
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Munich
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Germany
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Rotenburg
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Italy
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Bologna
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Italy
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Messina
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Italy
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Orbassano
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Japan
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Aichi
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Japan
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Aomori
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Ehime
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Fukuoka
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Gunma
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Hyogo
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Ishikawa
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Kanagawa
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Japan
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Miyagi
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Japan
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Okayama
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Japan
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Osaka
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Japan
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Tochigi
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Tokyo
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Japan
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Hiroshima
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Japan
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Niigata
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Korea, Republic of
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Chungcheongbukdo
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Korea, Republic of
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Daegu Gwang'yeogsi
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Gyeongsangbukdo
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Korea, Republic of
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Seoul Teugbyeolsi
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Mexico
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Monterrey
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Netherlands
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Harderwijk
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Heerlen
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Zwolle
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Bialystok
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Lodz
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Poznan
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Russian Federation
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Moskva
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Russian Federation
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Nizhegorodskaya Oblast'
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Russian Federation
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Omskaya Oblast'
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Russian Federation
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Sankt-Peterburg
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Alcorcon
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Majadahonda
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Malaga
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Murcia
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Orense
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Sevilla
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Valencia
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Taiwan
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Changhua
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Taiwan
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Taichung
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Taiwan
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Yunlin
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Thailand
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Bangkok
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Thailand
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Hat Yai
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Thailand
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Lak Si
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Thailand
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Muang
Country [111] 0 0
Thailand
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Ratchathewi
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Battalgazi
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Turkey
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Edirne
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Kocaeli
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Turkey
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Meram
Country [120] 0 0
Turkey
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Mersin City Hospital
Country [121] 0 0
Turkey
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Stanbul
Country [122] 0 0
Ukraine
State/province [122] 0 0
Kryvyi Rih
Country [123] 0 0
Ukraine
State/province [123] 0 0
Uzhgorod
Country [124] 0 0
Ukraine
State/province [124] 0 0
Uzhhorod

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BeiGene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Shun Lu
Address 0 0
Shanghai Chest Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BeiGene
Address 0 0
Country 0 0
Phone 0 0
1-877-828-5568
Fax 0 0
Email 0 0
clinicaltrials@beigene.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04746924