AzTrials
AzTrials

Carcinoma, Non-Small-Cell LungPhase 3RATIONALE001NCT03745222

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

A Phase 3 study testing Tislelizumab and Concurrent chemoradiotherapy (cCRT) in people with Carcinoma, Non-Small-Cell Lung, run by Celgene at 164 sites in 23 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Tislelizumab and Concurrent chemoradiotherapy (cCRT)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1 participants
Where
164 sitesin 23 countries
Study dates
22 May 2019to 26 Jun 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
  • Epidermal growth factor receptor (EGFR) mutation and anaplastic lymphoma kinase (ALK) gene translocation status available prior to randomization.
  • Provision of fresh or archival tumor tissue or discussion with Sponsor.
  • Adequate hematologic and end-organ function.

Who cannot join

  • 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).
  • History of severe hypersensitivity reactions to other monoclonal antibodies or any contraindication to the planned chemotherapy regimen.
  • History of, or ongoing, interstitial lung disease; pneumonitis requiring steroids; or clinically significant pericardial effusion.
  • 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.
  • 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.
  • Prior allogeneic stem cell transplantation or organ transplantation.
  • Significant cardiovascular disease or other condition which places the patient at risk.

Trial locations and contacts

164 sites in 23 countries.

164 sites in 23 countries

China33 sites

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, 100021

  • Chinese PLA General Hospital / 307 Hospital

    Beijing, 100071

  • Beijing Cancer Hospital - Beijing Institute for Cancer Research

    Beijing, 100142

  • Bengbu Medical College - First Affiliated Hospital

    Bengbu Shi, 233004

  • Jilin Province Cancer Hospital

    Changchun, 130012

  • First Hospital of Jilin University

    Changchun, 130021

  • Central South University - Xiangya School of Medicine - Hunan Cancer Hospital

    Changsha, 410013

  • Central South University - Xiangya School of Medicine - Hunan Cancer Hospital

    Changsha-shi, 410013

  • Sichuan Cancer Hospital & Institute

    Chengdu, 610041

  • Sichuan University - West China Hospital

    Chengdu, 610041

  • Foshan First People's Hospital

    Foshan, 528000

  • Cancer Center of Guangzhou Medical University

    Guangzhou, 510095

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510120

  • Zhejiang University School of Medicine - The Second Affiliated Hospital

    Hangzhou, 310016

  • Zhejiang Medical University - Zhejiang Cancer Hospital

    Hangzhou, 310022

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, 150081

  • Yunnan Cancer Hospital

    Kunming, 650118

  • Guangxi Tumour Institute and Hospital

    Nanning, 530021

  • Nantong Tumor Hospital

    Nantong, 226361

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

  • Shanghai Chest Hospital

    Shanghai Shi, 200030

  • Chongqing Cancer Hospital

    Shapingbaqu, 400030

  • Liaoning Cancer Hospital & Institute

    Shenyang, 110042

  • The First Hospital of Xinjiang Medical University

    Ürümqi, 830054

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, 430022

  • Zhongnan Hospital of Wuhan University

    Wuhan, 430023

  • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, 430030

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, 710061

  • First Hospital of Xiamen

    Xiamen, 361003

  • Fujian Medical University - Fujian Provincial Cancer Hospital

    Xidajie, 350014

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, 221002

  • Zhengzhou University (ZZU) - Henan Cancer Hospital

    Zhengzhou, 450008

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, 450052

Other trials in China

Japan16 sites

  • Osaka Prefectural Medical Center for Respiratory and Allergic Diseases

    Habikino-shi, 583-8588

  • Kansai Medical University Hospital

    Hirakata-shi, 573-1191

  • Hiroshima University Hospital

    Hiroshima, 734-8551

  • Kanazawa University Hospital

    Kanazawa

  • Matsusaka Municipal Hospital

    Matsusaka-shi, 515-8544

  • Toranomon Hospital

    Minatoku, 105-8470

  • Iwate Medical University Hospital

    Morioka, 020-8505

  • National Hospital Organization - Nagoya Medical Center

    Nagoya, 460-0001

  • Nagoya University Hospital

    Nagoya, 466-8560

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • Osaka City University Hospital

    Osaka, 545-8586

  • Gunma Prefectural Cancer Center

    Ōta-ku, 373-8550

  • Kitasato University Hospital

    Sagamihara, 252-0375

  • Sendai Kousei Hospital

    Sendai, 980-0873

  • Kanagawa Cardiovascular and Respiratory Center

    Yokohama, 236-0051

  • Yokohama Municipal Citizen's Hospital

    Yokohama, 240-8555

Other trials in Japan

United States14 sites

  • Center For Cancer and Blood Disorders

    Bethesda, Maryland, 20817

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana, 46845

  • Appalachian Regional Healthcare, Inc.

    Hazard, Kentucky, 41701

  • Millennium Oncology

    Houston, Texas, 77090

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Cancer Specialists of North Florida - Jacksonville

    Jacksonville, Florida, 32258-5472

  • Dayton Physicians, LLC

    Kettering, Ohio, 45409

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Norton Healthcare - Norton Cancer Institute

    Louisville, Kentucky, 40202

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Medical Oncology Associates, P.S.

    Spokane, Washington, 99208

  • Bond Clinic, P.A.

    Winter Haven, Florida, 33881

  • Mercy Health Youngstown Hospital, LLC

    Youngstown, Ohio, 44504

Other trials in United States

Germany13 sites

  • Medical Study Company NORD-WEST GmbH Oncology Aurich

    Aurich, 26603

  • Helios Klinikum Emil Von Behring

    Berlin, 14165

  • Kliniken der Stadt Koln gGmbH - Krankenhaus Merheim

    Cologne, 51109

  • Florence Nightingale KH der Kaiserwerther Diakonie

    Düsseldorf, 40489

  • Klinikum Esslingen GmbH

    Esslingen am Neckar, 73730

  • Asklepios Fachkliniken Muenchen Gauting

    Gauting, 82131

  • Oncological practice Goslar

    Goslar, 38642

  • Evangelisches Krankenhaus Hamm

    Hamm, 59063

  • Health Nordhessen Holding AG - Klinikum Kassel - Medical Clinic IV

    Kassel, 34125

  • Klinik Loewenstein gGmbH

    Löwenstein, 74245

  • LMU Klinikum der Universität

    München, 81377

  • St. Antonius-Hospital

    Schweiler, 52249

  • Medizinische Studiengesellschaft Nord-West

    Westerstede, 26655

Other trials in Germany

Greece10 sites

  • Sotiria Chest Hospital of Athens

    Athens, 11527

  • IASO General

    Athens, 15562

  • University General Hospital of Heraklion

    Heraklion, 71110

  • Agioi Anargyroi Cancer Hospital

    Kifissia, 14564

  • Metaxa Cancer Hospital of Piraeus

    Piraeus, 18537

  • Interbalkan Medical Center of Thessaloniki

    Pylaia, 570 01

  • University General Hospital of Patras

    Rio Patras, 26500

  • Bioclinic Thessaloniki Galinos clinic

    Thessaloniki, 54622

  • EUROMEDICA General Clinic of Thessaloniki

    Thessaloniki, 54645

  • Papageorgiou General Hospital of Thessaloniki

    Thessaloniki, 56429

Other trials in Greece

Spain10 sites

  • Hospital Universitario a Coruna

    A Coruña, 15006

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • Hospital Universitario Germans Trias i Pujol

    Barcelona, 08916

  • Insular-Maternal and Child University Hospital Complex

    Las Palmas de Gran Canaria, 35016

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Puerta de Hierro-Majadahonda

    Majadahonda, Madrid, 28222

  • Hospital General Carlos Haya

    Málaga, 29010

  • Hospital Universitario Central de Asturias

    Oviedo, 33011

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

Other trials in Spain

United Kingdom10 sites

  • University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

    Birmingham, B15 2TH

  • East Suffolk and North Essex NHS Foundation Trust - Colchester Hospital

    Colchester, CO4 5JL

  • University College London Hospitals NHS Foundation Trust - University College Hospital

    London, NW1 2BU

  • Guys Hospital

    London, SE1 9RT

  • Royal Marsden Hospital

    London, SW3 6JJ

  • Maidstone and Tunbridge Wells NHS Trust - Maidstone Hospital

    Maidstone, ME16 9QQ

  • Manchester University NHS Foundation Trust - Wythenshawe Hospital - North West Lung Centre

    Manchester, M23 9LT

  • The Hillingdon Hospitals NHS Foundation Trust - Mount Vernon Hospital

    Northwood, HA6 2RN

  • Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital

    Sheffield South Yorkshire, S10 2SS

  • Royal Cornwall Hospitals Trust

    Truro, TR1 3LJ

Other trials in United Kingdom

Portugal7 sites

  • Hospital Prof. Doutor Fernando Fonseca

    Amadora, 2720-276

  • Centro Hospitalar E Universitario de Coimbra EPE

    Coimbra, 3000-075

  • Centro Hospitalar do Alto Ave, Hospital da Senhora da Oliveira Guimaraes

    Guimarães, 4835-044

  • CUF Descobertas Hospital

    Lisbon, 1998-018

  • Centro Hospitalar do Porto - Hospital de Santo António

    Porto, 4099-001

  • CUF Porto Hospital

    Porto, 4100-180

  • Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe

    Porto, 4200-072

Other trials in Portugal

Romania7 sites

  • Oncology Institute Professor Doctor Alexandru Trestioreanu

    Bucharest, 022328

  • Prof. Dr. I. Chiricuta Institute of Oncology

    Cluj-Napoca, 400015

  • Medisprof SRL

    Cluj-Napoca, 400058

  • Sf. Apostol Andrei Constanta Emergency Clinical County Hospital

    Constanța, 900591

  • Oncology Center Sfantul Nectarie

    Craiova

  • Life Search SRL

    Timișoara, 300167

  • Oncocenter Clinical Oncology

    Timișoara, 300210

Other trials in Romania

Russia7 sites

  • Principal Military Clinical Hospital n.a. N.N. Burdenko

    Moscow, 105229

  • Omsk Regional Oncology Center

    Omsk, 610013

  • Ryazan State Medical University n.a. I.P. Pavlov

    Ryazan, 390026

  • Clinical Hospital of the Russian Academy of Sciences

    Saint Petersburg, 194017

  • GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)

    Saint Petersburg, 197758

  • Research Oncology Institute of Rosmed Technologies n.a. prof. N.N. Petrov

    Saint Petersburg, 197758

  • Mordovia State University

    Saransk, 43002

Other trials in Russia

Italy5 sites

  • Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele - Ospedale Gaspare Rodolico

    Catania, 95123

  • IRCCS AziendaOspedaliera Universitaria San Martino

    Genova, 16132

  • Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)

    Meldola, 47014

  • Universita Campus Bio-Medico di Roma

    Roma, 00128

  • Istituto Nazionale Tumori Regina Elena di Roma

    Roma, 00144

Other trials in Italy

Taiwan5 sites

  • Buddhist Dalin Tzu Chi General Hospital

    Dalin, 62247

  • E-DA Hospital

    Kaohsiung City, 82445

  • Kaohsiung Medical University Hospital

    Kaohsiung, San Ming Dist., 807

  • Chang Gung Medical Foundation, Kaohsiung Memorial Hospital

    Niao-Sung Hsiang Kaohsiung County, 83301

  • National Taiwan University Hospital

    Taipei, Zhongzheng Dist., 100

Other trials in Taiwan

Poland4 sites

  • Centrum Onkologii im. prof. Franciszka Lukaszczyka w Bydgoszczy

    Bydgoszcz, 85796

  • Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie

    Gliwice, 44-101

  • Med Polonia Sp. z o.o. NSZOZ

    Poznan, 60-693

  • Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie

    Warsaw, 02-781

Other trials in Poland

South Korea4 sites

  • Chungbuk National University Hospital

    Cheongju-si, 138-736

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Asan Medical Center

    Seoul, 5505

  • Ajou University Hospital

    Suwon, 16499

Other trials in South Korea

France3 sites

  • Centre Francois Baclesse

    Caen, 14076

  • Clinique Victor Hugo

    Le Mans, 72015

  • Institut de Cancerologie de l'Ouest (ICO) - Saint-Herblain

    Saint-Herblain, 44805

Other trials in France

Ireland3 sites

  • Beacon Hospital

    Dublin, D18 AK68

  • St James Hospital

    Dublin, Dublin 8

  • MidWestern Regional Hospital

    Limerick

Other trials in Ireland

Belgium2 sites

  • Universitair Ziekenhuis Brussel

    Brussels, 1090

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

Other trials in Belgium

Finland2 sites

  • Tampereen yliopistollinen sairaala

    Tampere, 33521

  • Turku University Hospital

    Turku, 20521

Other trials in Finland

Hungary2 sites

  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

    Székesfehérvár, 8000

  • Pulmonary Institute Torokbalint

    Törökbálint, 2045

Other trials in Hungary

Netherlands2 sites

  • Vrije Universiteit Medisch Centrum (VUMC)

    Amsterdam, 1081 HV

  • Gelre Hospitals

    Zutphen, 7207 AE

Other trials in Netherlands

New Zealand2 sites

  • Waikato Hospital

    Hamilton, 3204

  • Tauranga Hospital

    Tauranga, 3112

Other trials in New Zealand

Singapore2 sites

  • National University Hospital

    Singapore, 119074

  • Raffles Hospital

    Singapore, 188770

Other trials in Singapore

Canada1 site

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

Other trials in Canada

About this study

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

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. .

Being tested
Tislelizumab, Concurrent chemoradiotherapy (cCRT), Placebo
Keywords
Locally Advanced, Unresectable Non-Small Cell Lung Cancer, Non-Small Cell Lung Cancer, NSCLC, Randomized, BGB-A317, Tislelizumab, PD-1
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TislelizumabDrug

    Also called BGB-A317

    PD-1 inhibitor (monoclonal antibody against PD-1)

  • Concurrent chemoradiotherapy (cCRT)Drug

    Chemotherapy options include carboplatin/paclitaxel and cisplatin/etoposide per standard of care. Radiotherapy will also be given concurrently with chemotherapy.

  • PlaceboOther

    Placebo

Study groups in NCT03745222
Study groupRoleWhat they receive
Arm 1:Tislelizumab + cCRT followed by tislelizumab monotherapyExperimentalTislelizumab 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
Receives: Drug: Tislelizumab; Drug: Concurrent chemoradiotherapy (cCRT)
Arm 2: Placebo + cCRT followed by tislelizumab monotherapyExperimentalPlacebo 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.
Receives: Drug: Tislelizumab; Drug: Concurrent chemoradiotherapy (cCRT); Other: Placebo
Arm 3: Placebo + cCRT followed by placebo monotherapyPlacebo comparatorPlacebo 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.
Receives: Drug: Concurrent chemoradiotherapy (cCRT); Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS)

    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.

    Measured: Up to approximately 5 years; date of randomization to the date of tumor progression or death; until study withdrawal date of 26 June 2019

Secondary outcomes (10)

  1. Overall Survival (OS)

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

    Measured: Up to approximately 5 years; date of randomization to date of death from any cause.

  2. Overall Survival at 24 Months

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

    Measured: Up to approximately 24 months

  3. Percentage of Participants Who Achieved a Best Overall Response of Complete Response or Partial Response

    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).

    Measured: Up to approximately 5 years

  4. Duration of Response

    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.

    Measured: Up to approximately 5 years

  5. Percentage of Participants Alive and Progression-Free at 12 Months (APF12)

    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

    Measured: Up to 12 months

  6. Percentage of Participants Alive and Progression-free at 18 Months (APF18)

    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

    Measured: Up to approximately 18 months

  7. Time to Distant Metastasis (TTDM)

    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.

    Measured: Up to approximately 5 years

  8. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    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."

    Measured: From first dose of study drug up to study withdrawal date of 26 June 2019; 15 days.

  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

    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.

    Measured: Up to approximately 5 years

  10. Percentage of Participants Who Would Have Continued on to Monotherapy Phase

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

    Measured: Up to approximately 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2018
  2. Study start22 May 2019
  3. Primary completion26 Jun 2019
  4. Study completion26 Jun 2019

Why it stopped: BeiGene and Celgene Corporation terminated the parties' global collaboration for the compound, pending the acquisition of Celgene by Bristol Myers Squibb

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03745222
Sponsor's protocol ID
BGB-A317-NSCL-001
Other IDs
U1111-1216-4294, 2018-001132-22, 2018
Acronym
RATIONALE001
Status last verified
Jun 2020
First submitted
9 Nov 2018
Last updated
15 Jul 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tislelizumab and Concurrent chemoradiotherapy (cCRT) in people with Carcinoma, Non-Small-Cell Lung, run by Celgene at 164 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 164 sites in China, Japan, United States, Germany, Greece and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03745222.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2020.

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