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History of Changes for Study: NCT03358875
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
Latest version (submitted June 23, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 27, 2017 None (earliest Version on record)
2 June 27, 2018 Contacts/Locations and Study Status
3 October 25, 2018 Contacts/Locations, Arms and Interventions, Study Design, Outcome Measures, Study Status and Eligibility
4 January 7, 2019 Contacts/Locations, Eligibility, Arms and Interventions, Sponsor/Collaborators and Study Status
5 January 22, 2019 Contacts/Locations and Study Status
6 July 17, 2019 Study Status and Study Identification
7 September 9, 2019 Study Status
8 September 20, 2019 Contacts/Locations, Sponsor/Collaborators and Study Status
9 October 11, 2019 Study Status and Contacts/Locations
10 October 22, 2019 Contacts/Locations and Study Status
11 November 1, 2019 Contacts/Locations, Oversight and Study Status
12 November 6, 2019 Contacts/Locations and Study Status
13 April 20, 2020 Recruitment Status, Arms and Interventions, Study Status, Contacts/Locations, Study Design, Study Description, IPDSharing, Eligibility, Outcome Measures and Study Identification
14 June 15, 2020 Outcome Measures and Study Status
15 June 18, 2020 Study Status and Outcome Measures
16 June 19, 2020 Outcome Measures and Study Status
17 August 11, 2020 Contacts/Locations and Study Status
18 May 18, 2021 Study Status
19 August 16, 2021 Study Status and Contacts/Locations
20 June 23, 2022 Study Status and Contacts/Locations
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Study NCT03358875
Submitted Date:  November 27, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: BGB-A317-303
Brief 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
Official 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 IDs:
Open or close this module Study Status
Record Verification: November 2017
Overall Status: Recruiting
Study Start: November 7, 2017
Primary Completion: December 2020 [Anticipated]
Study Completion: June 2021 [Anticipated]
First Submitted: November 27, 2017
First Submitted that
Met QC Criteria:
November 27, 2017
First Posted: December 2, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
November 27, 2017
Last Update Posted: December 2, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: BeiGene
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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.
Detailed Description: This is a randomized, open-label, multicenter Phase 3 study in adult patients with histologically confirmed, locally advanced or metastatic (Stage IIIB or IV), NSCLC (squamous or non-squamous) who have disease progression during or after a platinum-containing regimen.
Open or close this module Conditions
Conditions: Non-small Cell Lung Cancer
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Single (Outcomes Assessor)
Allocation: Randomized
Enrollment: 640 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: BGB-A317
BGB-A317, 100 mg per vial, 200mg IV, Q3W
Drug: BGB-A317
Intravenous injection
Experimental: Docetaxel
Docetaxel 75 mg/m2 IV Q3W
Drug: Docetaxel
Intravenous injection
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Overall survival (OS)
[ Time Frame: Up to 34 months ]

Secondary Outcome Measures:
1. Objective response rate(ORR)
[ Time Frame: Up to 34 months ]

2. Duration of response (DOR)
[ Time Frame: Up to 34 months ]

3. Progression-free survival (PFS)
[ Time Frame: Up to 34 months ]

4. Health-related Quality of Life(HRQoL)
[ Time Frame: Up to 34 months ]

5. Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to NCI-CTCAE, v4.03.
[ Time Frame: Up to 34 months ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

Able to provide written informed consent and can understand and comply with the requirements of the study.

  1. Age18 years.
  2. Signed Informed Consent Form.
  3. Histologically confirmed locally advanced or metastatic (Stage IIIB or IV) NSCLC 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.
  5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
  6. Adequate hematologic and end-organ function.

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 acute effects of prior therapy of Grade 2-5, except for AEs (e.g. alopecia, neuropathy, specific lab abnormalities) not constituting a likely safety risk.
  4. History of severe hypersensitivity reactions to other mAbs.
  5. History of interstitial lung disease or non-infectious pneumonitis, except for those induced by radiation therapies.
  6. With uncontrollable pleural effusion, pericardial effusion, or clinically significant ascites requiring interventional treatment.
  7. Diagnosis of other malignancies with some exceptions.
  8. Active infection requiring systemic treatment, known HIV infection, subjects with untreated chronic hepatitis B or chronic HBV, active vaccination treatment.
  9. Insufficient cardiac functions and other underlying unfavorable conditions.
  10. Prior allogeneic stem cell transplantation or organ transplantation.
  11. Active autoimmune diseases or history of autoimmune diseases that may relapse should be excluded.
Open or close this module Contacts/Locations
Central Contact Person: Chen Cao
Telephone: +86 10 5895 8000
Email: ClinicalTrials@beigene.com
Locations: China, Beijing
Beijing Cancer Hospital
[Recruiting]
Beijing, Beijing, China, 100000
Contact:Contact: Ziping WANG 8613301212676 wangzp2007@126.com
Chinese PLA General Hospital
[Not yet recruiting]
Beijing, Beijing, China, 100853
Contact:Contact: Yi HU 8613911031186 huyi0401@aliyun.com
Beijing Chest Hospital, Capital Medical University
[Not yet recruiting]
Beijing, Beijing, China, 101149
Contact:Contact: Zhe LIU 8613651392121 lza@vip.163.com
China, Heilongjiang
Harbin Medical University Cancer Hospital
[Not yet recruiting]
Harbin, Heilongjiang, China, 150081
Contact:Contact: Yan YU 8613904505825 gpyuyan@163.com
China, Liaoning
The First Hospital of China Medical University
[Not yet recruiting]
Shenyang, Liaoning, China, 110001
Contact:Contact: Yunpeng LIU 8613898865122 cmu_trial@163.com
China, Shanghai
Shanghai Pulmonary Hospital
[Not yet recruiting]
Shanghai, Shanghai, China, 200433
Contact:Contact: Caicun ZHOU 8613301825532 caicunzhoudr@163.com
China, Tianjin
Tianjin Cancer Hospital
[Not yet recruiting]
Tianjin, Tianjin, China, 300060
Contact:Contact: Dingzhi HUANG 8613116047308 ec_tjich@126.com
China, Zhejiang
Zhejiang Cancer Hospital
[Not yet recruiting]
Hangzhou, Zhejiang, China, 310022
Contact:Contact: Xinmin YU 8613705718617 2231295153@qq.com
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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