Register a trial

Please note that the ANZCTR will be unattended on Friday 25th April due to the ANZAC Day public holiday. Submissions and updates will not be processed during that time.

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.



Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03358875




Registration number
NCT03358875
Ethics application status
Date submitted
27/11/2017
Date registered
2/12/2017

Titles & IDs
Public title
Comparison of Efficacy and Safety of Tislelizumab (BGB-A317) Versus Docetaxel as Treatment in the Second- or Third-line Setting in Participants With Non-Small Cell Lung Cancer (NSCLC)
Scientific 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
Secondary ID [1] 0 0
2018-000245-39
Secondary ID [2] 0 0
BGB-A317-303
Universal Trial Number (UTN)
Trial acronym
RATIONALE-303
Linked study record

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

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

Experimental: Tislelizumab - Participants received tislelizumab 200 mg intravenously (IV) once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.

Active comparator: Docetaxel - Participants received docetaxel 75 mg/m² IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.


Treatment: Drugs: Tislelizumab
Tislelizumab administered by intravenous (IV) infusion

Treatment: Drugs: Docetaxel
Docetaxel administered as an IV infusion over 1 hour
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) in All Participants (Co-primary Endpoint)
Timepoint [1] 0 0
From randomization to the data cutoff date of 10 August 2020; up to 32.4 months
Primary outcome [2] 0 0
Overall Survival (OS) in Programmed Cell Death Protein Ligand-1 (PD-L1)-Positive Participants (Co-primary Endpoint)
Timepoint [2] 0 0
From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months
Secondary outcome [1] 0 0
Objective Response Rate (ORR) in All Participants
Timepoint [1] 0 0
From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months
Secondary outcome [2] 0 0
Objective Response Rate in PD-L1-Positive Participants
Timepoint [2] 0 0
From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months
Secondary outcome [3] 0 0
Duration of Response (DOR) for All Responders
Timepoint [3] 0 0
From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months
Secondary outcome [4] 0 0
Duration of Response (DOR) in PD-L1-Positive Responders
Timepoint [4] 0 0
From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months
Secondary outcome [5] 0 0
Progression-free Survival (PFS) in All Participants
Timepoint [5] 0 0
From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months
Secondary outcome [6] 0 0
Progression-free Survival in PD-L1 Positive Participants
Timepoint [6] 0 0
From randomization up to the final efficacy analysis data cut-off date of 15 July 2021; Up to 43 months
Secondary outcome [7] 0 0
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL) Score
Timepoint [7] 0 0
Baseline and Cycle 6 (each cycle was 3 weeks)
Secondary outcome [8] 0 0
Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 Items (QLQ-LC13) Coughing, Dyspnoea, and Chest Pain Scores
Timepoint [8] 0 0
Baseline and Cycle 6 (each cycle was 3 weeks)
Secondary outcome [9] 0 0
Change From Baseline in European Quality of Life 5-Dimensions, 5-level (EQ-5D-5L) Visual Analogue Scale (VAS)
Timepoint [9] 0 0
Baseline and Cycle 6 (each cycle was 3 weeks)
Secondary outcome [10] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Timepoint [10] 0 0
From first dose of study drug to 30 days after last dose, up to the study completion date cut-off date of 18 January 2024 (up to approximately 63 months)

Eligibility
Key inclusion criteria
Key

1. Age = 18 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 epidermal growth factor (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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior therapies of docetaxel or treatment targeting programmed cell death protein 1 (PD-1), PD-L1 or cytotoxic T-lymphocyte associated protein 4 (CTLA-4).
2. Harboring EGFR sensitizing mutation or anaplastic lymphoma kinase (ALK) gene translocation.
3. Unresolved side effects of Grade 2 and above from prior anti-cancer therapies, except for adverse events (AEs) not constituting a likely safety risk (e.g. alopecia, rash, pigmentation, specific lab abnormalities).
4. History of severe hypersensitivity reactions to other monoclonal antibodies (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 human immunodeficiency virus (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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/01/2024
Sample size
Target
Accrual to date
Final
805
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Barretos
Country [2] 0 0
Brazil
State/province [2] 0 0
Cachoeiro de Itapemirim
Country [3] 0 0
Brazil
State/province [3] 0 0
Fortaleza
Country [4] 0 0
Brazil
State/province [4] 0 0
Ijui
Country [5] 0 0
Brazil
State/province [5] 0 0
Jau
Country [6] 0 0
Brazil
State/province [6] 0 0
Lajeado
Country [7] 0 0
Brazil
State/province [7] 0 0
Passo Fundo
Country [8] 0 0
Brazil
State/province [8] 0 0
Porto AlegreRS
Country [9] 0 0
Brazil
State/province [9] 0 0
Porto Alegre
Country [10] 0 0
Brazil
State/province [10] 0 0
Rio de Janeiro
Country [11] 0 0
Brazil
State/province [11] 0 0
Salvador
Country [12] 0 0
Brazil
State/province [12] 0 0
Santo Andre
Country [13] 0 0
Brazil
State/province [13] 0 0
Sao Jose do Rio Preto
Country [14] 0 0
Brazil
State/province [14] 0 0
Sao Paulo
Country [15] 0 0
Bulgaria
State/province [15] 0 0
Burgas
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Dobrich
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Gabrovo
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Rousse
Country [19] 0 0
Bulgaria
State/province [19] 0 0
Sofia
Country [20] 0 0
China
State/province [20] 0 0
Anhui
Country [21] 0 0
China
State/province [21] 0 0
Beijing
Country [22] 0 0
China
State/province [22] 0 0
Chongqing
Country [23] 0 0
China
State/province [23] 0 0
Guangdong
Country [24] 0 0
China
State/province [24] 0 0
Guangxi
Country [25] 0 0
China
State/province [25] 0 0
Guizhou
Country [26] 0 0
China
State/province [26] 0 0
Hainan
Country [27] 0 0
China
State/province [27] 0 0
Heilongjiang
Country [28] 0 0
China
State/province [28] 0 0
Henan
Country [29] 0 0
China
State/province [29] 0 0
Hubei
Country [30] 0 0
China
State/province [30] 0 0
Hunan
Country [31] 0 0
China
State/province [31] 0 0
Jiangsu
Country [32] 0 0
China
State/province [32] 0 0
Jiangxi
Country [33] 0 0
China
State/province [33] 0 0
Jilin
Country [34] 0 0
China
State/province [34] 0 0
Liaoning
Country [35] 0 0
China
State/province [35] 0 0
Shaanxi
Country [36] 0 0
China
State/province [36] 0 0
Shandong
Country [37] 0 0
China
State/province [37] 0 0
Shanghai
Country [38] 0 0
China
State/province [38] 0 0
Sichuan
Country [39] 0 0
China
State/province [39] 0 0
Tianjin
Country [40] 0 0
China
State/province [40] 0 0
Xinjiang
Country [41] 0 0
China
State/province [41] 0 0
Yunnan
Country [42] 0 0
China
State/province [42] 0 0
Zhejiang
Country [43] 0 0
Lithuania
State/province [43] 0 0
Kaunas
Country [44] 0 0
Lithuania
State/province [44] 0 0
Vilnius
Country [45] 0 0
Mexico
State/province [45] 0 0
Ciudad de Mexico
Country [46] 0 0
Mexico
State/province [46] 0 0
La Paz
Country [47] 0 0
Mexico
State/province [47] 0 0
Leon
Country [48] 0 0
Mexico
State/province [48] 0 0
Mexico
Country [49] 0 0
Mexico
State/province [49] 0 0
Monterrey
Country [50] 0 0
Mexico
State/province [50] 0 0
Morelia
Country [51] 0 0
Mexico
State/province [51] 0 0
Oaxaca
Country [52] 0 0
New Zealand
State/province [52] 0 0
Auckland
Country [53] 0 0
New Zealand
State/province [53] 0 0
Hamilton Waikato
Country [54] 0 0
New Zealand
State/province [54] 0 0
Tauranga
Country [55] 0 0
Poland
State/province [55] 0 0
Brzeziny
Country [56] 0 0
Poland
State/province [56] 0 0
Gdansk
Country [57] 0 0
Poland
State/province [57] 0 0
Lodz
Country [58] 0 0
Poland
State/province [58] 0 0
Olsztyn
Country [59] 0 0
Poland
State/province [59] 0 0
Ostroleka
Country [60] 0 0
Poland
State/province [60] 0 0
Otwock
Country [61] 0 0
Poland
State/province [61] 0 0
Szklarska Porba
Country [62] 0 0
Poland
State/province [62] 0 0
Warszawa
Country [63] 0 0
Russian Federation
State/province [63] 0 0
Arkhangel'skaya Oblast'
Country [64] 0 0
Russian Federation
State/province [64] 0 0
Irkutiskaya Oblast'
Country [65] 0 0
Russian Federation
State/province [65] 0 0
Mordoviya, Respublika
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Moskva
Country [67] 0 0
Russian Federation
State/province [67] 0 0
Omskaya Oblast'
Country [68] 0 0
Russian Federation
State/province [68] 0 0
Ryazanskaya Oblast'
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Sankt-Peterburg
Country [70] 0 0
Russian Federation
State/province [70] 0 0
Volgogradskaya Oblast'
Country [71] 0 0
Russian Federation
State/province [71] 0 0
SaintPetersburg
Country [72] 0 0
Slovakia
State/province [72] 0 0
Banska Bystrica
Country [73] 0 0
Slovakia
State/province [73] 0 0
Bardejov
Country [74] 0 0
Slovakia
State/province [74] 0 0
Bratislava
Country [75] 0 0
Slovakia
State/province [75] 0 0
Kosice
Country [76] 0 0
Slovakia
State/province [76] 0 0
Michalovce
Country [77] 0 0
Slovakia
State/province [77] 0 0
Nove Zamky
Country [78] 0 0
Slovakia
State/province [78] 0 0
Partizanske
Country [79] 0 0
Slovakia
State/province [79] 0 0
Poprad
Country [80] 0 0
Turkey
State/province [80] 0 0
Adana
Country [81] 0 0
Turkey
State/province [81] 0 0
Ankara
Country [82] 0 0
Turkey
State/province [82] 0 0
Battalgazi
Country [83] 0 0
Turkey
State/province [83] 0 0
Edirne
Country [84] 0 0
Turkey
State/province [84] 0 0
Istanbul
Country [85] 0 0
Turkey
State/province [85] 0 0
Izmir
Country [86] 0 0
Turkey
State/province [86] 0 0
Kocaeli
Country [87] 0 0
Turkey
State/province [87] 0 0
Meram
Country [88] 0 0
Turkey
State/province [88] 0 0
Stanbul
Country [89] 0 0
Turkey
State/province [89] 0 0
Tekirdag

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

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Caicun Zhou, PhD
Address 0 0
Shanghai Pulmonary Hospital, Shanghai, China
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?




Results publications and other study-related documents



Results are available at https://clinicaltrials.gov/study/NCT03358875