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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03358875
Ethics application status
Date submitted
27/11/2017
Date registered
2/12/2017
Date last updated
7/11/2019

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 Patients 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 - Intravenous injection BGB-A317
Treatment: Drugs - Intravenous injection Docetaxel

Experimental: BGB-A317 - BGB-A317, 100 mg per vial, 200mg IV, Q3W

Experimental: Docetaxel - Docetaxel 75 mg/m2 IV Q3W


Treatment: Drugs: Intravenous injection BGB-A317
Anti-PD-1 monoclonal antibody

Treatment: Drugs: Intravenous injection Docetaxel
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 patients (co-primary endpoint)
Timepoint [1] 0 0
Up to 34 months
Secondary outcome [1] 0 0
Objective response rate(ORR)
Timepoint [1] 0 0
Up to 34 months
Secondary outcome [2] 0 0
Duration of response (DOR)
Timepoint [2] 0 0
Up to 34 months
Secondary outcome [3] 0 0
Progression-free survival (PFS)
Timepoint [3] 0 0
Up to 34 months
Secondary outcome [4] 0 0
Health-related Quality of Life (HRQoL)
Timepoint [4] 0 0
Up to 34 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 34 months

Eligibility
Key inclusion criteria
1. Age18 years.

2. Signed Informed Consent Form.

3. Histologically confirmed locally advanced or metastatic (Stage IIIB or IV) NSCLC of
either squamous or non-squamous histology types with disease progression during or
following treatment with at least one platinum-containing regimen, but no more than 2
lines of systemic therapy.

4. Subjects must be able to provide fresh or archival tumor tissues for central
assessment of PD-L1 expression in tumor cells. Patients 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
Minimum age
18 Years
Maximum age
No limit
Gender
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 patients 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, subjects 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.

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Burgas
Country [8] 0 0
Bulgaria
State/province [8] 0 0
Dobrich
Country [9] 0 0
Bulgaria
State/province [9] 0 0
Gabrovo
Country [10] 0 0
Bulgaria
State/province [10] 0 0
Ruse
Country [11] 0 0
Bulgaria
State/province [11] 0 0
Sofia
Country [12] 0 0
China
State/province [12] 0 0
Anhui
Country [13] 0 0
China
State/province [13] 0 0
Beijing
Country [14] 0 0
China
State/province [14] 0 0
Chongqing
Country [15] 0 0
China
State/province [15] 0 0
Guangdong
Country [16] 0 0
China
State/province [16] 0 0
Guangxi
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China
State/province [17] 0 0
Guizhou
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China
State/province [18] 0 0
Hainan
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China
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Heilongjiang
Country [20] 0 0
China
State/province [20] 0 0
Henan
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China
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Hubei
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China
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Hunan
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China
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Jiangsu
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China
State/province [24] 0 0
Jiangxi
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China
State/province [25] 0 0
Jilin
Country [26] 0 0
China
State/province [26] 0 0
Liaoning
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China
State/province [27] 0 0
Shandong
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China
State/province [28] 0 0
Shanghai
Country [29] 0 0
China
State/province [29] 0 0
Shanxi
Country [30] 0 0
China
State/province [30] 0 0
Sichuan
Country [31] 0 0
China
State/province [31] 0 0
Tianjin
Country [32] 0 0
China
State/province [32] 0 0
Xinjiang
Country [33] 0 0
China
State/province [33] 0 0
Yunnan
Country [34] 0 0
China
State/province [34] 0 0
Zhejiang
Country [35] 0 0
China
State/province [35] 0 0
Hangzhou
Country [36] 0 0
China
State/province [36] 0 0
Wuhan
Country [37] 0 0
Lithuania
State/province [37] 0 0
Kaunas
Country [38] 0 0
Lithuania
State/province [38] 0 0
Vilnius
Country [39] 0 0
Mexico
State/province [39] 0 0
Baja California Sur
Country [40] 0 0
Mexico
State/province [40] 0 0
Distrito Federal
Country [41] 0 0
Mexico
State/province [41] 0 0
Guanajuato
Country [42] 0 0
Mexico
State/province [42] 0 0
Michoacán
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Mexico
State/province [43] 0 0
Nuevo León
Country [44] 0 0
Mexico
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Oaxaca
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New Zealand
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Grafton
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New Zealand
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Hamilton
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New Zealand
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Tauranga
Country [48] 0 0
New Zealand
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Wellington
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Poland
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Brzeziny
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Poland
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Gdansk
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Poland
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Olsztyn
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Ostroleka
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Otwock
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Szklarska Poreba
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Poland
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Warsaw
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Poland
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Lódz
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Russian Federation
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Arkhangel'sk
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Russian Federation
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Irkutsk
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Russian Federation
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Moscow
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Russian Federation
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Omsk
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Russian Federation
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Ryazan
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saransk
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Russian Federation
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Volgograd
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Slovakia
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Banska Bystrica
Country [66] 0 0
Slovakia
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Bardejov
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Slovakia
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Bratislava
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Slovakia
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Kosice
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Slovakia
State/province [69] 0 0
Michalovce
Country [70] 0 0
Slovakia
State/province [70] 0 0
Partizanske
Country [71] 0 0
Slovakia
State/province [71] 0 0
Poprad
Country [72] 0 0
Turkey
State/province [72] 0 0
Adana
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Turkey
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Ankara
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Turkey
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Edirne
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Kocaeli
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Turkey
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Konya
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Turkey
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Malatya
Country [80] 0 0
Turkey
State/province [80] 0 0
Tekirdag

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to show that BGB-A317 will improve overall survival in subjects
with Stage IIIB or IV non-small cell lung cancer when compared to docetaxel in second or
third-line treatment setting.
Trial website
https://clinicaltrials.gov/show/NCT03358875
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Yiyuan Ma, MD
Address 0 0
BeiGene
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BeiGene
Address 0 0
Country 0 0
Phone 0 0
+1-877-828-5568
Fax 0 0
Email 0 0
clinicaltrials@beigene.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03358875