RATIONALE001: A Study of Tislelizumab (BGB-A317) Plus Chemoradiotherapy Followed by Tislelizumab Monotherapy in Newly Diagnosed, Stage III Subjects With Locally Advanced, Unresectable Non-small Cell Lung Cancer

• Sponsor: Celgene (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03745222
• Collaborator: BeiGene (Industry)
• Enrollment: 1
• Locations: 164
• Arms: 3
• Actual Duration (Months): 1.1
• Patients Per Site: 0
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This is a Phase 3, randomized, double-blind, placebo-controlled multicenter global study designed to compare the efficacy and safety of tislelizumab in combination with concurrent chemoradiotherapy (cCRT) followed by tislelizumab monotherapy versus cCRT alone, and tislelizumab given sequentially after cCRT versus cCRT alone, in newly diagnosed stage III subjects with locally advanced, unresectable non-small cell lung cancer (NSCLC). The primary endpoint is centrally-assessed progression free survival (PFS) in the intent-to-treat (ITT) population. .

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Non-Small-Cell Lung	Drug: Tislelizumab; Drug: Concurrent chemoradiotherapy (cCRT); Other: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A PHASE 3, RANDOMIZED, BLINDED, PLACEBO-CONTROLLED STUDY OF TISLELIZUMAB (BGB-A317) PLUS CHEMORADIOTHERAPY FOLLOWED BY TISLELIZUMAB MONOTHERAPY IN NEWLY DIAGNOSED, STAGE III SUBJECTS WITH LOCALLY ADVANCED, UNRESECTABLE NON-SMALL CELL LUNG CANCER
• Actual Study Start Date: May 22, 2019
• Actual Primary Completion Date: Jun 26, 2019
• Actual Study Completion Date: Jun 26, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1:Tislelizumab + cCRT followed by tislelizumab monotherapy Tislelizumab 200 mg is administered by intravenous (IV) administration and given together upfront with concurrent platinum-based chemoradiotherapy (cCRT) for the first 6 weeks, followed by tislelizumab 200 mg by IV adminstration monotherapy. The standard platinum-based chemotherapy options include carboplatin/ paclitaxel and cisplatin/etoposide	Drug: Tislelizumab; PD-1 inhibitor (monoclonal antibody against PD-1); Other Names: BGB-A317 ; Drug: Concurrent chemoradiotherapy (cCRT); Chemotherapy options include carboplatin/paclitaxel and cisplatin/etoposide per standard of care. Radiotherapy will also be given concurrently with chemotherapy.
Experimental: Arm 2: Placebo + cCRT followed by tislelizumab monotherapy Placebo is given with concurrent platinum-based chemoradiotherapy (cCRT) for the first 6 weeks, followed by tislelizumab 200 mg by IV administration monotherapy. The standard platinum-based chemotherapy options include carboplatin/paclitaxel and cisplatin/etoposide.	Drug: Tislelizumab; PD-1 inhibitor (monoclonal antibody against PD-1); Other Names: BGB-A317 ; Drug: Concurrent chemoradiotherapy (cCRT); Chemotherapy options include carboplatin/paclitaxel and cisplatin/etoposide per standard of care. Radiotherapy will also be given concurrently with chemotherapy.; Other: Placebo; Placebo
Placebo Comparator: Arm 3: Placebo + cCRT followed by placebo monotherapy Placebo is given with concurrent platinum-based chemoradiotherapy (cCRT) for the first 6 weeks, followed by placebo monotherapy. The standard platinum-based chemotherapy options include carboplatin/paclitaxel and cisplatin/etoposide.	Drug: Concurrent chemoradiotherapy (cCRT); Chemotherapy options include carboplatin/paclitaxel and cisplatin/etoposide per standard of care. Radiotherapy will also be given concurrently with chemotherapy.; Other: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. Progression-Free Survival (PFS) [Up to approximately 5 years; date of randomization to the date of tumor progression or death; until study withdrawal date of 26 June 2019]

   Progression-free survival was defined as the time from the date of randomization to the date of the first objectively tumor progression as assessed by the blinded independent central review per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria (documented by radiological assessment) or death (any cause) on or prior to the clinical cut-off date, which ever occurred first. Stable disease-neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for Progressive disease (PD)• Progressive Disease- At least a 20% increase in the sum of diameters of target lesions from nadir.

Secondary Outcome Measures

1. Overall Survival (OS) [Up to approximately 5 years; date of randomization to date of death from any cause.]

   Overall survival was defined as the time between randomization of treatment and death from any cause.

2. Overall Survival at 24 Months [Up to approximately 24 months]

   Overall survival was defined as the time between randomization of treatment and death from any cause.

3. Percentage of Participants Who Achieved a Best Overall Response of Complete Response or Partial Response [Up to approximately 5 years]

   Overall Response was defined as percentage of participants who had a radiologic confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) guidelines, between Day 1 of treatment and subsequent anti-cancer therapy, death or study discontinuation. Complete response was defined as the disappearance of all target lesions; partial response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions from baseline; stable disease-neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease (PD).

4. Duration of Response [Up to approximately 5 years]

   Duration of Response is defined as the time from the first occurrence of a documented objective response to the time of relapse, as determined by blinded independent central review per RECIST v1.1, or death from any cause, whichever comes first.

5. Percentage of Participants Alive and Progression-Free at 12 Months (APF12) [Up to 12 months]

   Progression-free survival was defined as the time from the date of randomization to the date of the first objectively tumor progression as assessed by the blinded independent central review per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria (documented by radiological assessment) or death (any cause) on or prior to the clinical cut-off date, which ever occurred first

6. Percentage of Participants Alive and Progression-free at 18 Months (APF18) [Up to approximately 18 months]

   Progression-free survival was defined as the time from the date of randomization to the date of the first objectively tumor progression as assessed by the blinded independent central review per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria (documented by radiological assessment) or death (any cause) on or prior to the clinical cut-off date, which ever occurred first

7. Time to Distant Metastasis (TTDM) [Up to approximately 5 years]

   TTDM was defined as the time from the date of randomization until the first date of distant metastasis or death in the absence of distant metastasis. Distant metastasis was defined as any new lesion that is outside of the radiation field according to RECIST v1.1 or proven by biopsy.

8. Number of Participants With Treatment Emergent Adverse Events (TEAEs) [From first dose of study drug up to study withdrawal date of 26 June 2019; 15 days.]

   TEAEs include any adverse events (AEs) that had an onset date or a worsening in severity from baseline on or after the first dose of study drug up to 30 days following study drug discontinuation or initiation of new anticancer therapy, whichever occurred first. TEAEs also included all immune-related AEs recorded up to 90 days after the last dose of tislelizumab or placebo, regardless of whether or not the particpant started a new anticancer therapy. In addition, any serious AE with an onset date more than 30 days after the last dose of study drug that is assessed by the investigator as related to study drug were considered a TEAE."

9. Number of Participants With Lung Cancer Symptoms Assessed by the Corresponding Domains of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC-QLQ-C30) and Lung-Cancer Specific QLQ-LC13 [Up to approximately 5 years]

   The EORTC QLQ-C30 is a 30-item, questionnaire assessing quality of life (QoL), psychosocial burden and physical symptoms. It is classified into 15 domains: 5 functional subscales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning); 3 multi-item symptom subscales (fatigue, nausea/vomiting, and pain); each item is measured on a 4 point response scale; (not at all, a little, quite a bit, very much), with the exception of the 2 items measuring global health and QoL, (measured on a 7-point response scale). Scores are linearly transformed to 0 to 100 scores. Scores vary from 0 (worst) to 100 (best) for the functional dimensions and GHS, and from 0 (best) to 100 (worst) for the symptom dimensions; higher scores = better QoL, better functioning, or more severe symptoms, respectively. The LC13 covers 13 typical symptoms of lung cancer patients, such as coughing, pain, dyspnea, sore mouth, peripheral neuropathy, and hair loss.

10. Percentage of Participants Who Would Have Continued on to Monotherapy Phase [Up to approximately 5 years]

    Included the percentage of participants who would have received at least one dose of tislelizumab or placebo in the monotherapy phase before progression.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Newly diagnosed, histologically confirmed, locally advanced, stage III unresectable non small cell lung cancer (NSCLC).

Staging will be confirmed at screening by positron emission tomography-computed tomography (PET/CT) and brain imaging by magnetic resonance imaging (MRI) or computed tomography (CT) with contrast.

1. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.

2. Epidermal growth factor receptor (EGFR) mutation and anaplastic lymphoma kinase (ALK) gene translocation status available prior to randomization.

3. Provision of fresh or archival tumor tissue or discussion with Sponsor.

4. Adequate hematologic and end-organ function.

Exclusion Criteria:

1. Prior therapies including those targeting PD-1 or PD-L1 or chemotherapy, radiation, targeted therapy, biologic therapy, immunotherapy or investigational agent used to control non-small cell lung cancer (NSCLC).

2. History of severe hypersensitivity reactions to other monoclonal antibodies or any contraindication to the planned chemotherapy regimen.

3. History of, or ongoing, interstitial lung disease; pneumonitis requiring steroids; or clinically significant pericardial effusion.

4. Any active malignancy less than or equal to 2 years before randomization, with the exception of non-small cell lung cancer (NSCLC) and any locally recurring cancer that has been treated curatively.

5. Severe chronic or active infections including those requiring systemic antibacterial, antifungal or antiviral therapy; known human immunodeficiency virus (HIV) infection; untreated chronic hepatitis B or chronic hepatitis B virus carries or active hepatitis C; or active autoimmune disease.

6. Prior allogeneic stem cell transplantation or organ transplantation.

7. Significant cardiovascular disease or other condition which places the patient at risk.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	USC Norris Comprehensive Cancer Center	Los Angeles	California	United States	90033
2	Cancer Specialists of North Florida - Jacksonville	Jacksonville	Florida	United States	32258-5472
3	Bond Clinic, P.A.	Winter Haven	Florida	United States	33881
4	University of Chicago Medical Center	Chicago	Illinois	United States	60637
5	Fort Wayne Medical Oncology and Hematology	Fort Wayne	Indiana	United States	46845
6	Appalachian Regional Healthcare, Inc.	Hazard	Kentucky	United States	41701
7	Norton Healthcare - Norton Cancer Institute	Louisville	Kentucky	United States	40202
8	Center For Cancer and Blood Disorders	Bethesda	Maryland	United States	20817
9	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
10	Dayton Physicians, LLC	Kettering	Ohio	United States	45409
11	Mercy Health Youngstown Hospital, LLC	Youngstown	Ohio	United States	44504
12	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212
13	Millennium Oncology	Houston	Texas	United States	77090
14	Medical Oncology Associates, P.S.	Spokane	Washington	United States	99208
15	Universitair Ziekenhuis Brussel	Brussels		Belgium	1090
16	Cliniques Universitaires Saint-Luc	Brussels		Belgium	1200
17	Jewish General Hospital	Montreal	Quebec	Canada	H3T 1E2
18	Cancer Hospital Chinese Academy of Medical Sciences	Beijing		China	100021
19	Chinese PLA General Hospital / 307 Hospital	Beijing		China	100071
20	Beijing Cancer Hospital - Beijing Institute for Cancer Research	Beijing		China	100142
21	Bengbu Medical College - First Affiliated Hospital	Bengbu Shi		China	233004
22	Jilin Province Cancer Hospital	Changchun Shi		China	130012
23	First Hospital of Jilin University	Changchun		China	130021
24	Central South University - Xiangya School of Medicine - Hunan Cancer Hospital	Changsha-shi		China	410013
25	Central South University - Xiangya School of Medicine - Hunan Cancer Hospital	Changsha		China	410013
26	Sichuan Cancer Hospital & Institute	Chengdu		China	610041
27	Sichuan University - West China Hospital	Chengdu		China	610041
28	Foshan First People's Hospital	Foshan		China	528000
29	Fujian Medical University - Fujian Provincial Cancer Hospital	Fuzhou Shi		China	350014
30	Cancer Center of Guangzhou Medical University	Guangzhou		China	510095
31	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou		China	510120
32	Zhejiang University School of Medicine - The Second Affiliated Hospital	Hangzhou		China	310016
33	Zhejiang Medical University - Zhejiang Cancer Hospital	Hangzhou		China	310022
34	The First Affiliated Hospital of Harbin Medical University	Harbin		China	150081
35	Yunnan Cancer Hospital	Kunming Shi		China	650118
36	Guangxi Tumour Institute and Hospital	Nanning		China	530021
37	Nantong Tumor Hospital	Nantong		China	226361
38	Shanghai Chest Hospital	Shanghai Shi		China	200030
39	Fudan University Shanghai Cancer Center	Shanghai		China	200032
40	Chongqing Cancer Hospital	Shapingbaqu		China	400030
41	Liaoning Cancer Hospital & Institute	Shenyang Shi		China	110042
42	The First Hospital of Xinjiang Medical University	Urumqi		China	830054
43	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan		China	430022
44	Zhongnan Hospital of Wuhan University	Wuhan		China	430023
45	Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology	Wuhan		China	430030
46	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an City		China	710061
47	First Hospital of Xiamen	Xiamen		China	361003
48	The Affiliated Hospital of Xuzhou Medical University	Xuzhou		China	221002
49	Zhengzhou University (ZZU) - Henan Cancer Hospital	Zhengzhou		China	450008
50	The First Affiliated Hospital of Zhengzhou University	Zhengzhou		China	450052
51	Tampereen yliopistollinen sairaala	Tampere		Finland	33521
52	Turku University Hospital	Turku		Finland	20521
53	Centre Francois Baclesse	Caen Cedex 5		France	14076
54	Clinique Victor Hugo	Le Mans		France	72015
55	Institut de Cancerologie de l'Ouest (ICO) - Saint-Herblain	Saint Herblain		France	44805
56	Medical Study Company NORD-WEST GmbH Oncology Aurich	Aurich		Germany	26603
57	Helios Klinikum Emil Von Behring	Berlin		Germany	14165
58	Florence Nightingale KH der Kaiserwerther Diakonie	Dusseldorf		Germany	40489
59	Klinikum Esslingen GmbH	Esslingen Am Neckar		Germany	73730
60	Asklepios Fachkliniken Muenchen Gauting	Gauting		Germany	82131
61	Oncological practice Goslar	Goslar		Germany	38642
62	Evangelisches Krankenhaus Hamm	Hamm		Germany	59063
63	Health Nordhessen Holding AG - Klinikum Kassel - Medical Clinic IV	Kassel		Germany	34125
64	Kliniken der Stadt Koln gGmbH - Krankenhaus Merheim	Koln		Germany	51109
65	Klinik Loewenstein gGmbH	Loewenstein		Germany	74245
66	LMU Klinikum der Universität	München		Germany	81377
67	St. Antonius-Hospital	Schweiler		Germany	52249
68	Medizinische Studiengesellschaft Nord-West	Westerstede		Germany	26655
69	Sotiria Chest Hospital of Athens	Athens		Greece	11527
70	IASO General	Athens		Greece	15562
71	University General Hospital of Heraklion	Heraklion		Greece	71110
72	Agioi Anargyroi Cancer Hospital	Kifissia		Greece	14564
73	Metaxa Cancer Hospital of Piraeus	Piraeus		Greece	18537
74	Interbalkan Medical Center of Thessaloniki	Pylaia		Greece	570 01
75	University General Hospital of Patras	Rio Patras		Greece	26500
76	Bioclinic Thessaloniki Galinos clinic	Thessaloniki		Greece	54622
77	EUROMEDICA General Clinic of Thessaloniki	Thessaloniki		Greece	54645
78	Papageorgiou General Hospital of Thessaloniki	Thessaloniki		Greece	56429
79	Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz	Szekesfehervar		Hungary	8000
80	Pulmonary Institute Torokbalint	Torokbalint		Hungary	2045
81	Beacon Hospital	Dublin		Ireland	D18 AK68
82	St James Hospital	Dublin		Ireland	Dublin 8
83	MidWestern Regional Hospital	Limerick		Ireland
84	Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele - Ospedale Gaspare Rodolico	Catania		Italy	95123
85	IRCCS AziendaOspedaliera Universitaria San Martino	Genova		Italy	16132
86	Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)	Meldola		Italy	47014
87	Universita Campus Bio-Medico di Roma	Roma		Italy	00128
88	Istituto Nazionale Tumori Regina Elena di Roma	Roma		Italy	00144
89	Osaka Prefectural Medical Center for Respiratory and Allergic Diseases	Habikino-shi		Japan	583-8588
90	Kansai Medical University Hospital	Hirakata-shi		Japan	573-1191
91	Hiroshima University Hospital	Hiroshima		Japan	734-8551
92	Kanazawa University Hospital	Kanazawa-shi		Japan
93	Matsusaka Municipal Hospital	Matsusaka-shi		Japan	515-8544
94	Toranomon Hospital	Minato-ku		Japan	105-8470
95	Iwate Medical University Hospital	Morioka		Japan	020-8505
96	National Hospital Organization - Nagoya Medical Center	Nagoya-shi		Japan	460-0001
97	Nagoya University Hospital	Nagoya-shi		Japan	466-8560
98	Niigata Cancer Center Hospital	Niigata-shi		Japan	951-8566
99	Osaka City University Hospital	Osaka		Japan	545-8586
100	Gunma Prefectural Cancer Center	Ota-ku		Japan	373-8550
101	Kitasato University Hospital	Sagamihara		Japan	252-0375
102	Sendai Kousei Hospital	Sendai-shi		Japan	980-0873
103	Kanagawa Cardiovascular and Respiratory Center	Yokohama-shi		Japan	236-0051
104	Yokohama Municipal Citizen's Hospital	Yokohama-shi		Japan	240-8555
105	Chungbuk National University Hospital	Cheongju		Korea, Republic of	138-736
106	Seoul National University Bundang Hospital	Seongnam-si		Korea, Republic of	13620
107	Asan Medical Center	Seoul		Korea, Republic of	5505
108	Ajou University Hospital	Suwon si		Korea, Republic of	16499
109	Vrije Universiteit Medisch Centrum (VUMC)	Amsterdam		Netherlands	1081 HV
110	Gelre Hospitals	Zutphen		Netherlands	7207 AE
111	Waikato Hospital	Hamilton		New Zealand	3204
112	Tauranga Hospital	Tauranga		New Zealand	3112
113	Centrum Onkologii im. prof. Franciszka Lukaszczyka w Bydgoszczy	Bydgoszcz		Poland	85796
114	Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie	Gliwice		Poland	44-101
115	Med Polonia Sp. z o.o. NSZOZ	Poznan		Poland	60-693
116	Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie	Warszawa		Poland	02-781
117	Hospital Prof. Doutor Fernando Fonseca	Amadora		Portugal	2720-276
118	Centro Hospitalar E Universitario de Coimbra EPE	Coimbra		Portugal	3000-075
119	Centro Hospitalar do Alto Ave, Hospital da Senhora da Oliveira Guimaraes	Guimaraes		Portugal	4835-044
120	CUF Descobertas Hospital	Lisboa		Portugal	1998-018
121	Centro Hospitalar do Porto - Hospital de Santo António	Porto		Portugal	4099-001
122	CUF Porto Hospital	Porto		Portugal	4100-180
123	Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe	Porto		Portugal	4200-072
124	Oncology Institute Professor Doctor Alexandru Trestioreanu	Bucharest		Romania	022328
125	Prof. Dr. I. Chiricuta Institute of Oncology	Cluj-Napoca		Romania	400015
126	Medisprof SRL	Cluj-Napoca		Romania	400058
127	Sf. Apostol Andrei Constanta Emergency Clinical County Hospital	Constanta		Romania	900591
128	Oncology Center Sfantul Nectarie	Craiova		Romania
129	Life Search SRL	Timisoara		Romania	300167
130	Oncocenter Clinical Oncology	Timisoara		Romania	300210
131	Principal Military Clinical Hospital n.a. N.N. Burdenko	Moscow		Russian Federation	105229
132	Omsk Regional Oncology Center	Omsk		Russian Federation	610013
133	Ryazan State Medical University n.a. I.P. Pavlov	Ryazan		Russian Federation	390026
134	Mordovia State University	Saransk		Russian Federation	43002
135	Clinical Hospital of the Russian Academy of Sciences	St. Petersburg		Russian Federation	194017
136	GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)	St. Petersburg		Russian Federation	197758
137	Research Oncology Institute of Rosmed Technologies n.a. prof. N.N. Petrov	St. Petersburg		Russian Federation	197758
138	National University Hospital	Singapore		Singapore	119074
139	Raffles Hospital	Singapore		Singapore	188770
140	Hospital Universitario a Coruna	A Coruna		Spain	15006
141	Hospital General Universitario de Alicante	Alicante		Spain	03010
142	Hospital Universitario Germans Trias i Pujol	Barcelona		Spain	08916
143	Insular-Maternal and Child University Hospital Complex	Las Palmas de Gran Canaria		Spain	35016
144	Hospital Universitario Fundacion Jimenez Diaz	Madrid		Spain	28040
145	Hospital Universitario 12 de Octubre	Madrid		Spain	28041
146	Hospital Universitario Puerta de Hierro-Majadahonda	Majadahonda, Madrid		Spain	28222
147	Hospital General Carlos Haya	Malaga		Spain	29010
148	Hospital Universitario Central de Asturias	Oviedo		Spain	33011
149	Hospital Universitari i Politecnic La Fe de Valencia	Valencia		Spain	46026
150	Buddhist Dalin Tzu Chi General Hospital	Dalin		Taiwan	62247
151	Kaohsiung Medical University Hospital	Kaohsiung, San Ming Dist.		Taiwan	807
152	E-DA Hospital	Kaohsiung		Taiwan	82445
153	Chang Gung Medical Foundation, Kaohsiung Memorial Hospital	Niao-Sung Hsiang Kaohsiung County		Taiwan	83301
154	National Taiwan University Hospital	Taipei, Zhongzheng Dist.		Taiwan	100
155	University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital	Birmingham		United Kingdom	B15 2TH
156	East Suffolk and North Essex NHS Foundation Trust - Colchester Hospital	Colchester		United Kingdom	CO4 5JL
157	University College London Hospitals NHS Foundation Trust - University College Hospital	London		United Kingdom	NW1 2BU
158	Guys Hospital	London		United Kingdom	SE1 9RT
159	Royal Marsden Hospital	London		United Kingdom	SW3 6JJ
160	Maidstone and Tunbridge Wells NHS Trust - Maidstone Hospital	Maidstone		United Kingdom	ME16 9QQ
161	Manchester University NHS Foundation Trust - Wythenshawe Hospital - North West Lung Centre	Manchester		United Kingdom	M23 9LT
162	The Hillingdon Hospitals NHS Foundation Trust - Mount Vernon Hospital	Northwood		United Kingdom	HA6 2RN
163	Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital	Sheffield South Yorkshire		United Kingdom	S10 2SS
164	Royal Cornwall Hospitals Trust	Truro		United Kingdom	TR1 3LJ

Sponsors and Collaborators

• Celgene
• BeiGene

Investigators

• Study Director: Marie Nguyen, MD, Celgene

Study Documents (Full-Text)

• Study Protocol - Sep 20, 2018
• Statistical Analysis Plan - May 7, 2019

More Information

Publications

None provided.

• Responsible Party: Celgene
• ClinicalTrials.gov Identifier: NCT03745222
• Other Study ID Numbers: BGB-A317-NSCL-001; U1111-1216-4294; 2018-001132-22
• First Posted: Nov 19, 2018
• Last Update Posted: Jul 15, 2020
• Last Verified: Jun 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Celgene: Locally Advanced, Unresectable Non-Small Cell Lung Cancer; Non-Small Cell Lung Cancer; NSCLC; Randomized; BGB-A317; Tislelizumab; PD-1
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Study Results

Participant Flow

Recruitment Details	One participant was enrolled in the United States before the study was terminated.

Arm/Group Title	Tislelizumab + Concurrent Chemoradiotherapy -Tislelizumab	Placebo + Concurrent Chemoradiotherapy -Tislelizumab	Placebo + Concurrent Chemoradiotherapy - Placebo
Arm/Group Description	Participants were to receive 2 cycles of tislelizumab 200 mg by intravenous (IV) infusion every 3 weeks (Q3W) with concurrent chemoradiotherapy (cCRT), followed by monotherapy with tislelizumab 200 mg IV Q3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.	Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with tislelizumab 200 mg IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.	Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with placebo IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.
Period Title: Overall Study
STARTED	0	1	0
COMPLETED	0	0	0
NOT COMPLETED	0	1	0

Baseline Characteristics

Arm/Group Title	Tislelizumab + Concurrent Chemoradiotherapy -Tislelizumab	Placebo + Concurrent Chemoradiotherapy -Tislelizumab	Placebo + Concurrent Chemoradiotherapy - Placebo	Total
Arm/Group Description	Participants were to receive 2 cycles of tislelizumab 200 mg by intravenous (IV) infusion every 3 weeks (Q3W) with concurrent chemoradiotherapy (cCRT), followed by monotherapy with tislelizumab 200 mg IV Q3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.	Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with tislelizumab 200 mg IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.	Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with placebo IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.	Total of all reporting groups
Overall Participants	0	1	0	1
Age (Count of Participants)
<=18 years	0 NaN	0 0%
Between 18 and 65 years	1 Infinity	1 100%
>=65 years	0 NaN	0 0%
Sex: Female, Male (Count of Participants)
Female	0 NaN	1 100%	0 NaN	1 100%
Male	0 NaN	0 0%	0 NaN	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 NaN	0 0%	0 NaN	0 0%
Not Hispanic or Latino	0 NaN	1 100%	0 NaN	1 100%
Unknown or Not Reported	0 NaN	0 0%	0 NaN	0 0%
Race/Ethnicity, Customized (Count of Participants)
Caucasian	0 NaN	1 100%	0 NaN	1 100%

Outcome Measures

1. Primary Outcome

Title	Progression-Free Survival (PFS)
Description	Progression-free survival was defined as the time from the date of randomization to the date of the first objectively tumor progression as assessed by the blinded independent central review per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria (documented by radiological assessment) or death (any cause) on or prior to the clinical cut-off date, which ever occurred first. Stable disease-neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for Progressive disease (PD)• Progressive Disease- At least a 20% increase in the sum of diameters of target lesions from nadir.
Time Frame	Up to approximately 5 years; date of randomization to the date of tumor progression or death; until study withdrawal date of 26 June 2019

Outcome Measure Data

Analysis Population Description

The study was terminated. The number of participants and the data collection period were not sufficient for statistical analysis. The patient withdrew consent.

Arm/Group Title	Tislelizumab + Concurrent Chemoradiotherapy -Tislelizumab	Placebo + Concurrent Chemoradiotherapy -Tislelizumab	Placebo + Concurrent Chemoradiotherapy - Placebo
Arm/Group Description	Participants were to receive 2 cycles of tislelizumab 200 mg by intravenous (IV) infusion every 3 weeks (Q3W) with concurrent chemoradiotherapy (cCRT), followed by monotherapy with tislelizumab 200 mg IV Q3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.	Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with tislelizumab 200 mg IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.	Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with placebo IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.
Measure Participants	0	0	0

2. Secondary Outcome

Title	Overall Survival (OS)
Description	Overall survival was defined as the time between randomization of treatment and death from any cause.
Time Frame	Up to approximately 5 years; date of randomization to date of death from any cause.

Outcome Measure Data

Analysis Population Description

The study was terminated. The number of participants and the data collection period were not sufficient for statistical analysis. The patient withdrew consent.

Arm/Group Title	Tislelizumab + Concurrent Chemoradiotherapy -Tislelizumab	Placebo + Concurrent Chemoradiotherapy -Tislelizumab	Placebo + Concurrent Chemoradiotherapy - Placebo
Arm/Group Description	Participants were to receive 2 cycles of tislelizumab 200 mg by intravenous (IV) infusion every 3 weeks (Q3W) with concurrent chemoradiotherapy (cCRT), followed by monotherapy with tislelizumab 200 mg IV Q3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.	Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with tislelizumab 200 mg IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.	Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with placebo IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.
Measure Participants	0	0	0

3. Secondary Outcome

Title	Overall Survival at 24 Months
Description	Overall survival was defined as the time between randomization of treatment and death from any cause.
Time Frame	Up to approximately 24 months

Outcome Measure Data

Analysis Population Description

The study was terminated. The number of participants and the data collection period were not sufficient for statistical analysis. The patient withdrew consent.

Arm/Group Title	Tislelizumab + Concurrent Chemoradiotherapy -Tislelizumab	Placebo + Concurrent Chemoradiotherapy -Tislelizumab	Placebo + Concurrent Chemoradiotherapy - Placebo
Arm/Group Description	Participants were to receive 2 cycles of tislelizumab 200 mg by intravenous (IV) infusion every 3 weeks (Q3W) with concurrent chemoradiotherapy (cCRT), followed by monotherapy with tislelizumab 200 mg IV Q3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.	Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with tislelizumab 200 mg IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.	Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with placebo IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.
Measure Participants	0	0	0

4. Secondary Outcome

Title	Percentage of Participants Who Achieved a Best Overall Response of Complete Response or Partial Response
Description	Overall Response was defined as percentage of participants who had a radiologic confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) guidelines, between Day 1 of treatment and subsequent anti-cancer therapy, death or study discontinuation. Complete response was defined as the disappearance of all target lesions; partial response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions from baseline; stable disease-neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease (PD).
Time Frame	Up to approximately 5 years

Outcome Measure Data

Analysis Population Description

The study was terminated. The number of participants and the data collection period were not sufficient for statistical analysis. The patient withdrew consent.

Arm/Group Title	Tislelizumab + Concurrent Chemoradiotherapy -Tislelizumab	Placebo + Concurrent Chemoradiotherapy -Tislelizumab	Placebo + Concurrent Chemoradiotherapy - Placebo
Arm/Group Description	Participants were to receive 2 cycles of tislelizumab 200 mg by intravenous (IV) infusion every 3 weeks (Q3W) with concurrent chemoradiotherapy (cCRT), followed by monotherapy with tislelizumab 200 mg IV Q3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.	Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with tislelizumab 200 mg IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.	Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with placebo IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.
Measure Participants	0	0	0

5. Secondary Outcome

Title	Duration of Response
Description	Duration of Response is defined as the time from the first occurrence of a documented objective response to the time of relapse, as determined by blinded independent central review per RECIST v1.1, or death from any cause, whichever comes first.
Time Frame	Up to approximately 5 years

Outcome Measure Data

Analysis Population Description

The study was terminated. The number of participants and the data collection period were not sufficient for statistical analysis. The patient withdrew consent.

Arm/Group Title	Tislelizumab + Concurrent Chemoradiotherapy -Tislelizumab	Placebo + Concurrent Chemoradiotherapy -Tislelizumab	Placebo + Concurrent Chemoradiotherapy - Placebo
Arm/Group Description	Participants were to receive 2 cycles of tislelizumab 200 mg by intravenous (IV) infusion every 3 weeks (Q3W) with concurrent chemoradiotherapy (cCRT), followed by monotherapy with tislelizumab 200 mg IV Q3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.	Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with tislelizumab 200 mg IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.	Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with placebo IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.
Measure Participants	0	0	0

6. Secondary Outcome

Title	Percentage of Participants Alive and Progression-Free at 12 Months (APF12)
Description	Progression-free survival was defined as the time from the date of randomization to the date of the first objectively tumor progression as assessed by the blinded independent central review per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria (documented by radiological assessment) or death (any cause) on or prior to the clinical cut-off date, which ever occurred first
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

The study was terminated. The number of participants and the data collection period were not sufficient for statistical analysis. The patient withdrew consent.

Arm/Group Title	Tislelizumab + Concurrent Chemoradiotherapy -Tislelizumab	Placebo + Concurrent Chemoradiotherapy -Tislelizumab	Placebo + Concurrent Chemoradiotherapy - Placebo
Arm/Group Description	Participants were to receive 2 cycles of tislelizumab 200 mg by intravenous (IV) infusion every 3 weeks (Q3W) with concurrent chemoradiotherapy (cCRT), followed by monotherapy with tislelizumab 200 mg IV Q3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.	Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with tislelizumab 200 mg IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.	Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with placebo IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.
Measure Participants	0	0	0

7. Secondary Outcome

Title	Percentage of Participants Alive and Progression-free at 18 Months (APF18)
Description	Progression-free survival was defined as the time from the date of randomization to the date of the first objectively tumor progression as assessed by the blinded independent central review per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria (documented by radiological assessment) or death (any cause) on or prior to the clinical cut-off date, which ever occurred first
Time Frame	Up to approximately 18 months

Outcome Measure Data

Analysis Population Description

The study was terminated. The number of participants and the data collection period were not sufficient for statistical analysis. The patient withdrew consent.

Arm/Group Title	Tislelizumab + Concurrent Chemoradiotherapy -Tislelizumab	Placebo + Concurrent Chemoradiotherapy -Tislelizumab	Placebo + Concurrent Chemoradiotherapy - Placebo
Arm/Group Description	Participants were to receive 2 cycles of tislelizumab 200 mg by intravenous (IV) infusion every 3 weeks (Q3W) with concurrent chemoradiotherapy (cCRT), followed by monotherapy with tislelizumab 200 mg IV Q3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.	Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with tislelizumab 200 mg IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.	Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with placebo IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.
Measure Participants	0	0	0

8. Secondary Outcome

Title	Time to Distant Metastasis (TTDM)
Description	TTDM was defined as the time from the date of randomization until the first date of distant metastasis or death in the absence of distant metastasis. Distant metastasis was defined as any new lesion that is outside of the radiation field according to RECIST v1.1 or proven by biopsy.
Time Frame	Up to approximately 5 years

Outcome Measure Data

Analysis Population Description

The study was terminated. The number of participants and the data collection period were not sufficient for statistical analysis. The patient withdrew consent.

Arm/Group Title	Tislelizumab + Concurrent Chemoradiotherapy -Tislelizumab	Placebo + Concurrent Chemoradiotherapy -Tislelizumab	Placebo + Concurrent Chemoradiotherapy - Placebo
Arm/Group Description	Participants were to receive 2 cycles of tislelizumab 200 mg by intravenous (IV) infusion every 3 weeks (Q3W) with concurrent chemoradiotherapy (cCRT), followed by monotherapy with tislelizumab 200 mg IV Q3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.	Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with tislelizumab 200 mg IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.	Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with placebo IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.
Measure Participants	0	0	0

9. Secondary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Description	TEAEs include any adverse events (AEs) that had an onset date or a worsening in severity from baseline on or after the first dose of study drug up to 30 days following study drug discontinuation or initiation of new anticancer therapy, whichever occurred first. TEAEs also included all immune-related AEs recorded up to 90 days after the last dose of tislelizumab or placebo, regardless of whether or not the particpant started a new anticancer therapy. In addition, any serious AE with an onset date more than 30 days after the last dose of study drug that is assessed by the investigator as related to study drug were considered a TEAE."
Time Frame	From first dose of study drug up to study withdrawal date of 26 June 2019; 15 days.

Outcome Measure Data

Analysis Population Description

Safety population includes participants who received at least 1 dose of study drug.

Arm/Group Title	Tislelizumab + Concurrent Chemoradiotherapy -Tislelizumab	Placebo + Concurrent Chemoradiotherapy -Tislelizumab	Placebo + Concurrent Chemoradiotherapy - Placebo
Arm/Group Description	Participants were to receive 2 cycles of tislelizumab 200 mg by intravenous (IV) infusion every 3 weeks (Q3W) with concurrent chemoradiotherapy (cCRT), followed by monotherapy with tislelizumab 200 mg IV Q3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.	Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with tislelizumab 200 mg IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.	Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with placebo IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.
Measure Participants	0	1	0
≥ 1 TEAE	1 Infinity
≥ 1 Treatment Related TEAE	1 Infinity

10. Secondary Outcome

Title	Number of Participants With Lung Cancer Symptoms Assessed by the Corresponding Domains of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC-QLQ-C30) and Lung-Cancer Specific QLQ-LC13
Description	The EORTC QLQ-C30 is a 30-item, questionnaire assessing quality of life (QoL), psychosocial burden and physical symptoms. It is classified into 15 domains: 5 functional subscales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning); 3 multi-item symptom subscales (fatigue, nausea/vomiting, and pain); each item is measured on a 4 point response scale; (not at all, a little, quite a bit, very much), with the exception of the 2 items measuring global health and QoL, (measured on a 7-point response scale). Scores are linearly transformed to 0 to 100 scores. Scores vary from 0 (worst) to 100 (best) for the functional dimensions and GHS, and from 0 (best) to 100 (worst) for the symptom dimensions; higher scores = better QoL, better functioning, or more severe symptoms, respectively. The LC13 covers 13 typical symptoms of lung cancer patients, such as coughing, pain, dyspnea, sore mouth, peripheral neuropathy, and hair loss.
Time Frame	Up to approximately 5 years

Outcome Measure Data

Analysis Population Description

The study was terminated. The number of participants and the data collection period were not sufficient for statistical analysis. The patient withdrew consent.

Arm/Group Title	Tislelizumab + Concurrent Chemoradiotherapy -Tislelizumab	Placebo + Concurrent Chemoradiotherapy -Tislelizumab	Placebo + Concurrent Chemoradiotherapy - Placebo
Arm/Group Description	Participants were to receive 2 cycles of tislelizumab 200 mg by intravenous (IV) infusion every 3 weeks (Q3W) with concurrent chemoradiotherapy (cCRT), followed by monotherapy with tislelizumab 200 mg IV Q3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.	Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with tislelizumab 200 mg IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.	Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with placebo IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.
Measure Participants	0	0	0

11. Secondary Outcome

Title	Percentage of Participants Who Would Have Continued on to Monotherapy Phase
Description	Included the percentage of participants who would have received at least one dose of tislelizumab or placebo in the monotherapy phase before progression.
Time Frame	Up to approximately 5 years

Outcome Measure Data

Analysis Population Description

The study was terminated. The number of participants and the data collection period were not sufficient for statistical analysis. The patient withdrew consent.

Arm/Group Title	Tislelizumab + Concurrent Chemoradiotherapy -Tislelizumab	Placebo + Concurrent Chemoradiotherapy -Tislelizumab	Placebo + Concurrent Chemoradiotherapy - Placebo
Arm/Group Description	Participants were to receive 2 cycles of tislelizumab 200 mg by intravenous (IV) infusion every 3 weeks (Q3W) with concurrent chemoradiotherapy (cCRT), followed by monotherapy with tislelizumab 200 mg IV Q3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.	Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with tislelizumab 200 mg IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.	Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with placebo IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.
Measure Participants	0	0	0

Adverse Events

Time Frame	From first dose of study drug up to study withdrawal date of 26 June 2019; 15 days.
Adverse Event Reporting Description	No serious adverse events or deaths occurred during the course of the study,
Arm/Group Title	Tislelizumab + Concurrent Chemoradiotherapy -Tislelizumab		Placebo + Concurrent Chemoradiotherapy -Tislelizumab		Placebo + Concurrent Chemoradiotherapy - Placebo
Arm/Group Description	Participants were to receive 2 cycles of tislelizumab 200 mg by intravenous (IV) infusion every 3 weeks (Q3W) with concurrent chemoradiotherapy (cCRT), followed by monotherapy with tislelizumab 200 mg IV Q3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.		Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with tislelizumab 200 mg IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.		Participants were to receive 2 cycles of identically matching placebo by IV infusion Q 3 weeks with cCRT, followed by monotherapy with placebo IV Q 3W until disease progression, death, unacceptable toxicity, subject or physician decision, withdrawal of consent or treatment discontinuation for another reason.
All Cause Mortality
	Tislelizumab + Concurrent Chemoradiotherapy -Tislelizumab		Placebo + Concurrent Chemoradiotherapy -Tislelizumab		Placebo + Concurrent Chemoradiotherapy - Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/1 (0%)		0/0 (NaN)
Serious Adverse Events
	Tislelizumab + Concurrent Chemoradiotherapy -Tislelizumab		Placebo + Concurrent Chemoradiotherapy -Tislelizumab		Placebo + Concurrent Chemoradiotherapy - Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/1 (0%)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Tislelizumab + Concurrent Chemoradiotherapy -Tislelizumab		Placebo + Concurrent Chemoradiotherapy -Tislelizumab		Placebo + Concurrent Chemoradiotherapy - Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		1/1 (100%)		0/0 (NaN)
Injury, poisoning and procedural complications
Infusion Related Reaction	0/0 (NaN)		1/1 (100%)		0/0 (NaN)
Musculoskeletal and connective tissue disorders
MUSCLE CRAMPING	0/0 (NaN)		1/1 (100%)		0/0 (NaN)
NECK PAIN	0/0 (NaN)		1/1 (100%)		0/0 (NaN)
Respiratory, thoracic and mediastinal disorders
Cough	0/0 (NaN)		1/1 (100%)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Results from a center cannot be submitted for publication before results of multicenter study are published unless it is > 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 additional days. Investigator must delete confidential information before submission and defer publication to permit patent applications.