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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 Anti-PD-1 Antibody BGB-A317 Versus Docetaxel as Treatment in the Second- or Third-line Setting in Participants With 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
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: BGB-A317 - 100 mg per vial, 200mg intravenous (IV), Q3W

Experimental: Docetaxel - 75 mg/m2 IV Q3W


Treatment: Drugs: Tislelizumab
Intravenous injection (Anti-PD-1 monoclonal antibody)

Treatment: Drugs: Docetaxel
Intravenous injection (Antineoplastic, cytotoxic, taxane)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival (OS) in PD-L1+ and all participants (co-primary endpoint)
Timepoint [1] 0 0
Up to 31 months
Secondary outcome [1] 0 0
Objective response rate(ORR)
Timepoint [1] 0 0
Up to 31 months
Secondary outcome [2] 0 0
Duration of response (DOR)
Timepoint [2] 0 0
Up to 31 months
Secondary outcome [3] 0 0
Progression-free survival (PFS)
Timepoint [3] 0 0
Up to 31 months
Secondary outcome [4] 0 0
Health-related Quality of Life (HRQoL)
Timepoint [4] 0 0
Up to 31 months
Secondary outcome [5] 0 0
Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to NCI-CTCAE, v4.03.
Timepoint [5] 0 0
Up to 31 months

Eligibility
Key inclusion criteria
Key

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

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

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

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
Bahia
Country [2] 0 0
Brazil
State/province [2] 0 0
Ceará
Country [3] 0 0
Brazil
State/province [3] 0 0
Espírito Santo
Country [4] 0 0
Brazil
State/province [4] 0 0
Rio De Janiero
Country [5] 0 0
Brazil
State/province [5] 0 0
Rio Grande Do Sul
Country [6] 0 0
Brazil
State/province [6] 0 0
Sao Paulo
Country [7] 0 0
Bulgaria
State/province [7] 0 0
Gabrovo
Country [8] 0 0
Bulgaria
State/province [8] 0 0
Sofia
Country [9] 0 0
China
State/province [9] 0 0
Anhui
Country [10] 0 0
China
State/province [10] 0 0
Beijing
Country [11] 0 0
China
State/province [11] 0 0
Chongqing
Country [12] 0 0
China
State/province [12] 0 0
Guangdong
Country [13] 0 0
China
State/province [13] 0 0
Guangxi
Country [14] 0 0
China
State/province [14] 0 0
Guizhou
Country [15] 0 0
China
State/province [15] 0 0
Heilongjiang
Country [16] 0 0
China
State/province [16] 0 0
Henan
Country [17] 0 0
China
State/province [17] 0 0
Hubei
Country [18] 0 0
China
State/province [18] 0 0
Hunan
Country [19] 0 0
China
State/province [19] 0 0
Jiangsu
Country [20] 0 0
China
State/province [20] 0 0
Jiangxi
Country [21] 0 0
China
State/province [21] 0 0
Jilin
Country [22] 0 0
China
State/province [22] 0 0
Liaoning
Country [23] 0 0
China
State/province [23] 0 0
Shandong
Country [24] 0 0
China
State/province [24] 0 0
Shanghai
Country [25] 0 0
China
State/province [25] 0 0
Shanxi
Country [26] 0 0
China
State/province [26] 0 0
Sichuan
Country [27] 0 0
China
State/province [27] 0 0
Xinjiang
Country [28] 0 0
China
State/province [28] 0 0
Yunnan
Country [29] 0 0
China
State/province [29] 0 0
Zhejiang
Country [30] 0 0
China
State/province [30] 0 0
Hangzhou
Country [31] 0 0
China
State/province [31] 0 0
Wuhan
Country [32] 0 0
Lithuania
State/province [32] 0 0
Kaunas
Country [33] 0 0
Lithuania
State/province [33] 0 0
Vilnius
Country [34] 0 0
Mexico
State/province [34] 0 0
Baja California Sur
Country [35] 0 0
Mexico
State/province [35] 0 0
Distrito Federal
Country [36] 0 0
Mexico
State/province [36] 0 0
Guanajuato
Country [37] 0 0
Mexico
State/province [37] 0 0
Nuevo León
Country [38] 0 0
New Zealand
State/province [38] 0 0
Grafton
Country [39] 0 0
New Zealand
State/province [39] 0 0
Hamilton
Country [40] 0 0
New Zealand
State/province [40] 0 0
Tauranga
Country [41] 0 0
Poland
State/province [41] 0 0
Olsztyn
Country [42] 0 0
Poland
State/province [42] 0 0
Lódz
Country [43] 0 0
Russian Federation
State/province [43] 0 0
Arkhangel'sk
Country [44] 0 0
Russian Federation
State/province [44] 0 0
Irkutsk
Country [45] 0 0
Russian Federation
State/province [45] 0 0
Moscow
Country [46] 0 0
Russian Federation
State/province [46] 0 0
Omsk
Country [47] 0 0
Russian Federation
State/province [47] 0 0
Saint Petersburg
Country [48] 0 0
Russian Federation
State/province [48] 0 0
Saransk
Country [49] 0 0
Slovakia
State/province [49] 0 0
Banska Bystrica
Country [50] 0 0
Slovakia
State/province [50] 0 0
Partizanske
Country [51] 0 0
Slovakia
State/province [51] 0 0
Poprad
Country [52] 0 0
Turkey
State/province [52] 0 0
Adana
Country [53] 0 0
Turkey
State/province [53] 0 0
Ankara
Country [54] 0 0
Turkey
State/province [54] 0 0
Edirne
Country [55] 0 0
Turkey
State/province [55] 0 0
Istanbul
Country [56] 0 0
Turkey
State/province [56] 0 0
Kocaeli
Country [57] 0 0
Turkey
State/province [57] 0 0
Malatya
Country [58] 0 0
Turkey
State/province [58] 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
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03358875