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Comparison of Efficacy and Safety of Anti-PD-1 Antibody BGB-A317 Versus Docetaxel as Treatment in the Second- or Third-line Setting in Participants With NSCLC

Primary Purpose

Non-small Cell Lung Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tislelizumab
Docetaxel
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

Eligibility Criteria

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

Key Inclusion Criteria:

  1. Age18 years.
  2. Signed Informed Consent Form.
  3. Histologically confirmed locally advanced or metastatic (Stage IIIB or IV) NSCLC of either squamous or non-squamous histology types with disease progression during or following treatment with at least one platinum-containing regimen, but no more than 2 lines of systemic therapy.
  4. Participants must be able to provide fresh or archival tumor tissues for central assessment of PD-L1 expression in tumor cells. Participants with non-squamous histology must provide evidence of not harboring sensitizing EGFR mutation tested by a histology-based method.
  5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
  6. Adequate hematologic and end-organ function.
  7. Expected life span > 12 weeks.
  8. Willing to be compliance with birth control requirement during pre-specified study participating period

Key Exclusion Criteria:

  1. Prior therapies of docetaxel or treatment targeting PD-1, PD-L1 or CTLA-4.
  2. Harboring EGFR sensitizing mutation or ALK gene translocation.
  3. Unresolved side effects of Grade 2 and above from prior anti-cancer therapies, except for AEs not constituting a likely safety risk (e.g. alopecia, rash, pigmentation, specific lab abnormalities).
  4. History of severe hypersensitivity reactions to other mAbs.
  5. History of interstitial lung disease, non-infectious pneumonitis or participants with significantly impaired pulmonary function, or who require supplemental oxygen at baseline.
  6. With uncontrollable pleural effusion, pericardial effusion, or clinically significant ascites requiring interventional treatment.
  7. Active Leptomeningeal disease or uncontrolled, untreated brain metastasis.
  8. Severe chronic or active infection requiring systemic treatment.
  9. Known HIV infection, participants with untreated chronic hepatitis B, active vaccination treatment.
  10. Insufficient cardiac functions and other underlying unfavorable cardiovascular conditions.
  11. Prior allogeneic stem cell transplantation or organ transplantation.
  12. Active autoimmune diseases or history of autoimmune diseases that may relapse.
  13. With conditions requiring systemic treatment with either corticosteroids (>10 mg daily prednisone or equivalent) or other immunosuppressive medications.
  14. With severe underlying medical conditions (including laboratory abnormalities) or alcohol or drug abuse that may affect the explanation of drug toxicity or AEs or result in impaired compliance with study conduct.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

  • NOB - Núcleo de Oncologia da Bahia
  • Hospital Haroldo Juaçaba - Instituto do Câncer do Ceará
  • Hospital Evangélico de Cachoeiro de Itapemirim
  • INCA - Instituto Nacional de Câncer
  • Hospital de Caridade de Ijuí
  • Hospital de Clínicas de Porto Alegre
  • Hospital de Câncer de Barretos - Fundação Pio XII
  • Fundação Doutor Amaral Carvalho
  • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
  • Fundação Faculdade Regional de Medicina de São José do Rio Preto
  • ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
  • MHAT "Dr. Tota Venkova", AD
  • Acibadem City Clinic Tokuda Hospital Ead
  • Anhui Provincial Hospital
  • The First Affiliated Hospital of Anhui Medical University
  • Chinese PLA General Hospital
  • Beijing Chest Hospital, Capital Medical University
  • Cancer Hospital Chinese Academy of Medical Sciences City: Beijing
  • Peking Union Medical College Hospital
  • Beijing Cancer Hospital
  • Daping Hospital of The 3rd Military University
  • Cancer Center of Guangzhou Medical University
  • Guangzhou Institute of Respiratory
  • Cancer Hospital of Shantou University Medical College
  • The First Affiliated Hospital of Guangxi Medical University
  • The Affiliated Hospital of Zunyi Medical College
  • Harbin Medical University Cancer Hospital
  • Henan Cancer Hospital
  • Hubei cancer hospital
  • Changsha Central Hospital
  • Hunan Cancer Hospital
  • Xiangya Hospital of Central South University
  • Jiangsu Province Hospital
  • Nantong Tumor Hospital
  • The Second Hospital Affiliated to Suzhou University
  • Xuzhou Central Hospital
  • Jiangxi cancer hospital
  • Jilin Cancer Hospital
  • The First Hospital of Jilin University
  • Liaoning Cancer Hospital & Institute
  • The First Hospital of China Medical University
  • Jinan Central Hospital
  • Linyi Cancer Hospital
  • Shanghai Pulmonary Hospital
  • Ruijin hospital， Shanghai Jiao Tong University School of Medicine
  • First Affiliated Hospital of Xi'an Jiaotong University
  • Sichuan Provincial People's Hospital
  • The First Affiliated Hospital of Xinjiang Medical University
  • Yunnan Cancer Hospital
  • The First Affiliated Hospital of College of Medicine, Zhejiang University
  • Zhejiang Cancer Hospital
  • The First Affiliated Hospital of Wenzhou Medical University
  • The Second Affiliated Hospital of Zhejiang University School of Medicine
  • Tongji Hospital of Tongji Medical College Huazhong University of Science Technology
  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics branch Oncology Hospital
  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics
  • National Cancer Institute
  • Investigacion Onco Farmaceutica (OncoTech)
  • Health Pharma Professional Research S.A. de C.V.
  • Fundacion Rodolfo Padilla Padilla, A.C.
  • Accelerium S de RL de CV
  • Auckland City Hospital
  • Waikato Hospital
  • Tauranga Hospital
  • SP Zespol Gruzlicy i Chorob Pluc w Olsztynie
  • Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna
  • SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"
  • Irkutsk Regional Oncology Dispensary
  • FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
  • "VitaMed" LLC
  • BHI of Omsk region "Clinical Oncology Dispensary"
  • Private Medical Institution "Evromedservis"
  • Pavlov First Saint Petersburg State Medical University
  • FSBI of higher education"Ogarev Mordovia State University"
  • Fakultna nemocnica s poliklinikou F.D. Roosevelta
  • Nemocnica na okraji mesta, n.o.
  • POKO Poprad s.r.o.
  • Acibadem Adana Hospital
  • Hacettepe University
  • Trakya University Medical Faculty
  • Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
  • Bakirkoy Dr. Sadi Konuk Teaching and Research Hospital
  • Istanbul Medeniyet Uni Goztepe Training&Res Hosp
  • Kocaeli Universitesi Tip Fakultesi
  • Inonu Uni. Med. Fac.
  • Namik Kemal University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

BGB-A317

Docetaxel

Arm Description

100 mg per vial, 200mg intravenous (IV), Q3W

75 mg/m2 IV Q3W

Outcomes

Primary Outcome Measures

Overall survival (OS) in PD-L1+ and all participants (co-primary endpoint)

Secondary Outcome Measures

Objective response rate(ORR)
Duration of response (DOR)
Progression-free survival (PFS)
Health-related Quality of Life (HRQoL)
Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to NCI-CTCAE, v4.03.

Full Information

First Posted
November 27, 2017
Last Updated
July 28, 2023
Sponsor
BeiGene
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1. Study Identification

Unique Protocol Identification Number
NCT03358875
Brief Title
Comparison of Efficacy and Safety of Anti-PD-1 Antibody BGB-A317 Versus Docetaxel as Treatment in the Second- or Third-line Setting in Participants With NSCLC
Official Title
A Phase 3, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of BGB-A317 (Anti-PD1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer Who Have Progressed on a Prior Platinum-Containing Regimen
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 30, 2017 (Actual)
Primary Completion Date
August 10, 2020 (Actual)
Study Completion Date
December 2023 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to show that BGB-A317 will improve overall survival in participants with Stage IIIB or IV non-small cell lung cancer when compared to docetaxel in second or third-line treatment setting.
Detailed Description
This is a randomized, open-label, multicenter Phase 3 study in adult participants with histologically confirmed, locally advanced or metastatic (Stage IIIB or IV), NSCLC (squamous or non-squamous) who have disease progression during or after a platinum-containing regimen.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
805 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BGB-A317
Arm Type
Experimental
Arm Description
100 mg per vial, 200mg intravenous (IV), Q3W
Arm Title
Docetaxel
Arm Type
Experimental
Arm Description
75 mg/m2 IV Q3W
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Other Intervention Name(s)
BGB-A317
Intervention Description
Intravenous injection (Anti-PD-1 monoclonal antibody)
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Intravenous injection (Antineoplastic, cytotoxic, taxane)
Primary Outcome Measure Information:
Title
Overall survival (OS) in PD-L1+ and all participants (co-primary endpoint)
Time Frame
Up to 31 months
Secondary Outcome Measure Information:
Title
Objective response rate(ORR)
Time Frame
Up to 31 months
Title
Duration of response (DOR)
Time Frame
Up to 31 months
Title
Progression-free survival (PFS)
Time Frame
Up to 31 months
Title
Health-related Quality of Life (HRQoL)
Time Frame
Up to 31 months
Title
Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to NCI-CTCAE, v4.03.
Time Frame
Up to 31 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Age18 years. Signed Informed Consent Form. Histologically confirmed locally advanced or metastatic (Stage IIIB or IV) NSCLC of either squamous or non-squamous histology types with disease progression during or following treatment with at least one platinum-containing regimen, but no more than 2 lines of systemic therapy. Participants must be able to provide fresh or archival tumor tissues for central assessment of PD-L1 expression in tumor cells. Participants with non-squamous histology must provide evidence of not harboring sensitizing EGFR mutation tested by a histology-based method. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1. Adequate hematologic and end-organ function. Expected life span > 12 weeks. Willing to be compliance with birth control requirement during pre-specified study participating period Key Exclusion Criteria: Prior therapies of docetaxel or treatment targeting PD-1, PD-L1 or CTLA-4. Harboring EGFR sensitizing mutation or ALK gene translocation. Unresolved side effects of Grade 2 and above from prior anti-cancer therapies, except for AEs not constituting a likely safety risk (e.g. alopecia, rash, pigmentation, specific lab abnormalities). History of severe hypersensitivity reactions to other mAbs. History of interstitial lung disease, non-infectious pneumonitis or participants with significantly impaired pulmonary function, or who require supplemental oxygen at baseline. With uncontrollable pleural effusion, pericardial effusion, or clinically significant ascites requiring interventional treatment. Active Leptomeningeal disease or uncontrolled, untreated brain metastasis. Severe chronic or active infection requiring systemic treatment. Known HIV infection, participants with untreated chronic hepatitis B, active vaccination treatment. Insufficient cardiac functions and other underlying unfavorable cardiovascular conditions. Prior allogeneic stem cell transplantation or organ transplantation. Active autoimmune diseases or history of autoimmune diseases that may relapse. With conditions requiring systemic treatment with either corticosteroids (>10 mg daily prednisone or equivalent) or other immunosuppressive medications. With severe underlying medical conditions (including laboratory abnormalities) or alcohol or drug abuse that may affect the explanation of drug toxicity or AEs or result in impaired compliance with study conduct. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caicun Zhou, PhD
Organizational Affiliation
Shanghai Pulmonary Hospital, Shanghai, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
NOB - Núcleo de Oncologia da Bahia
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40170-110
Country
Brazil
Facility Name
Hospital Haroldo Juaçaba - Instituto do Câncer do Ceará
City
Fortaleza
State/Province
Ceará
ZIP/Postal Code
60430-230
Country
Brazil
Facility Name
Hospital Evangélico de Cachoeiro de Itapemirim
City
Cachoeiro De Itapemirim
State/Province
Espírito Santo
ZIP/Postal Code
29308-020
Country
Brazil
Facility Name
INCA - Instituto Nacional de Câncer
City
Rio De Janeiro
State/Province
Rio De Janiero
ZIP/Postal Code
20231-050
Country
Brazil
Facility Name
Hospital de Caridade de Ijuí
City
Ijuí
State/Province
Rio Grande Do Sul
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
900350-903
Country
Brazil
Facility Name
Hospital de Câncer de Barretos - Fundação Pio XII
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Fundação Doutor Amaral Carvalho
City
Jaú
State/Province
Sao Paulo
ZIP/Postal Code
17210-120
Country
Brazil
Facility Name
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
City
Santo Andre
State/Province
Sao Paulo
ZIP/Postal Code
09060-650
Country
Brazil
Facility Name
Fundação Faculdade Regional de Medicina de São José do Rio Preto
City
São José do Rio Preto
State/Province
Sao Paulo
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
MHAT "Dr. Tota Venkova", AD
City
Gabrovo
Country
Bulgaria
Facility Name
Acibadem City Clinic Tokuda Hospital Ead
City
Sofia
Country
Bulgaria
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
Country
China
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
Country
China
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Beijing Chest Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences City: Beijing
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijin
State/Province
Beijing
Country
China
Facility Name
Daping Hospital of The 3rd Military University
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
Cancer Center of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Guangzhou Institute of Respiratory
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Cancer Hospital of Shantou University Medical College
City
Shantou
State/Province
Guangdong
Country
China
Facility Name
The First Affiliated Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
Country
China
Facility Name
The Affiliated Hospital of Zunyi Medical College
City
Zunyi
State/Province
Guizhou
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Hubei cancer hospital
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Changsha Central Hospital
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Nantong Tumor Hospital
City
Nantong
State/Province
Jiangsu
Country
China
Facility Name
The Second Hospital Affiliated to Suzhou University
City
Suzhou
State/Province
Jiangsu
Country
China
Facility Name
Xuzhou Central Hospital
City
Xuzhou
State/Province
Jiangsu
Country
China
Facility Name
Jiangxi cancer hospital
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Facility Name
Liaoning Cancer Hospital & Institute
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
The First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
Jinan Central Hospital
City
Jinan
State/Province
Shandong
Country
China
Facility Name
Linyi Cancer Hospital
City
Linyi
State/Province
Shandong
Country
China
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Ruijin hospital， Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
First Affiliated Hospital of Xi'an Jiaotong University
City
Xian
State/Province
Shanxi
Country
China
Facility Name
Sichuan Provincial People's Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
The First Affiliated Hospital of Xinjiang Medical University
City
Ürümqi
State/Province
Xinjiang
Country
China
Facility Name
Yunnan Cancer Hospital
City
Kunming
State/Province
Yunnan
Country
China
Facility Name
The First Affiliated Hospital of College of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
Country
China
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
ZIP/Postal Code
Zhejiang
Country
China
Facility Name
Tongji Hospital of Tongji Medical College Huazhong University of Science Technology
City
Wuhan
ZIP/Postal Code
Hubei
Country
China
Facility Name
Hospital of Lithuanian University of Health Sciences Kaunas Clinics branch Oncology Hospital
City
Kaunas
Country
Lithuania
Facility Name
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
City
Kaunas
Country
Lithuania
Facility Name
National Cancer Institute
City
Vilnius
Country
Lithuania
Facility Name
Investigacion Onco Farmaceutica (OncoTech)
City
La Paz
State/Province
Baja California Sur
ZIP/Postal Code
23040
Country
Mexico
Facility Name
Health Pharma Professional Research S.A. de C.V.
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
03810
Country
Mexico
Facility Name
Fundacion Rodolfo Padilla Padilla, A.C.
City
León
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Facility Name
Accelerium S de RL de CV
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64000
Country
Mexico
Facility Name
Auckland City Hospital
City
Grafton
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
Country
New Zealand
Facility Name
Tauranga Hospital
City
Tauranga
ZIP/Postal Code
3112
Country
New Zealand
Facility Name
SP Zespol Gruzlicy i Chorob Pluc w Olsztynie
City
Olsztyn
ZIP/Postal Code
10-357
Country
Poland
Facility Name
Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna
City
Łódź
ZIP/Postal Code
90-242
Country
Poland
Facility Name
SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"
City
Arkhangel'sk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Irkutsk Regional Oncology Dispensary
City
Irkutsk
ZIP/Postal Code
664011
Country
Russian Federation
Facility Name
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
"VitaMed" LLC
City
Moscow
ZIP/Postal Code
129515
Country
Russian Federation
Facility Name
BHI of Omsk region "Clinical Oncology Dispensary"
City
Omsk
ZIP/Postal Code
644046
Country
Russian Federation
Facility Name
Private Medical Institution "Evromedservis"
City
Saint Petersburg
ZIP/Postal Code
196603
Country
Russian Federation
Facility Name
Pavlov First Saint Petersburg State Medical University
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
FSBI of higher education"Ogarev Mordovia State University"
City
Saransk
ZIP/Postal Code
430005
Country
Russian Federation
Facility Name
Fakultna nemocnica s poliklinikou F.D. Roosevelta
City
Banska Bystrica
Country
Slovakia
Facility Name
Nemocnica na okraji mesta, n.o.
City
Partizanske
Country
Slovakia
Facility Name
POKO Poprad s.r.o.
City
Poprad
Country
Slovakia
Facility Name
Acibadem Adana Hospital
City
Adana
ZIP/Postal Code
11300
Country
Turkey
Facility Name
Hacettepe University
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Facility Name
Trakya University Medical Faculty
City
Edirne
ZIP/Postal Code
22130
Country
Turkey
Facility Name
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
City
Istanbul
ZIP/Postal Code
34096
Country
Turkey
Facility Name
Bakirkoy Dr. Sadi Konuk Teaching and Research Hospital
City
Istanbul
ZIP/Postal Code
34147
Country
Turkey
Facility Name
Istanbul Medeniyet Uni Goztepe Training&Res Hosp
City
Istanbul
ZIP/Postal Code
34732
Country
Turkey
Facility Name
Kocaeli Universitesi Tip Fakultesi
City
Kocaeli
ZIP/Postal Code
41000
Country
Turkey
Facility Name
Inonu Uni. Med. Fac.
City
Malatya
ZIP/Postal Code
44000
Country
Turkey
Facility Name
Namik Kemal University
City
Tekirdağ
ZIP/Postal Code
59030
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Comparison of Efficacy and Safety of Anti-PD-1 Antibody BGB-A317 Versus Docetaxel as Treatment in the Second- or Third-line Setting in Participants With NSCLC

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