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Trial record 2 of 66 for:    "BGB-A317"

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

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ClinicalTrials.gov Identifier: NCT03358875
Recruitment Status : Active, not recruiting
First Posted : December 2, 2017
Last Update Posted : May 19, 2021
Sponsor:
Information provided by (Responsible Party):
BeiGene

Tracking Information
First Submitted Date  ICMJE November 27, 2017
First Posted Date  ICMJE December 2, 2017
Last Update Posted Date May 19, 2021
Actual Study Start Date  ICMJE November 30, 2017
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2020)
Overall survival (OS) in PD-L1+ and all participants (co-primary endpoint) [ Time Frame: Up to 31 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 27, 2017)
Overall survival (OS) [ Time Frame: Up to 34 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2020)
  • Objective response rate(ORR) [ Time Frame: Up to 31 months ]
  • Duration of response (DOR) [ Time Frame: Up to 31 months ]
  • Progression-free survival (PFS) [ Time Frame: Up to 31 months ]
  • Health-related Quality of Life (HRQoL) [ Time Frame: Up to 31 months ]
  • Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to NCI-CTCAE, v4.03. [ Time Frame: Up to 31 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2017)
  • Objective response rate(ORR) [ Time Frame: Up to 34 months ]
  • Duration of response (DOR) [ Time Frame: Up to 34 months ]
  • Progression-free survival (PFS) [ Time Frame: Up to 34 months ]
  • Health-related Quality of Life (HRQoL) [ Time Frame: Up to 34 months ]
  • Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to NCI-CTCAE, v4.03. [ Time Frame: Up to 34 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary The purpose of this study is to show that BGB-A317 will improve overall survival in participants 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 participants 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-small Cell Lung Cancer
Intervention  ICMJE
  • Drug: Tislelizumab
    Intravenous injection (Anti-PD-1 monoclonal antibody)
    Other Name: BGB-A317
  • Drug: Docetaxel
    Intravenous injection (Antineoplastic, cytotoxic, taxane)
Study Arms  ICMJE
  • Experimental: BGB-A317
    100 mg per vial, 200mg intravenous (IV), Q3W
    Intervention: Drug: Tislelizumab
  • Experimental: Docetaxel
    75 mg/m2 IV Q3W
    Intervention: Drug: Docetaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 20, 2020)
805
Original Estimated Enrollment  ICMJE
 (submitted: November 27, 2017)
640
Estimated Study Completion Date  ICMJE December 30, 2021
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. 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 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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil,   Bulgaria,   China,   Lithuania,   Mexico,   New Zealand,   Poland,   Russian Federation,   Slovakia,   Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03358875
Other Study ID Numbers  ICMJE BGB-A317-303
2018-000245-39 ( EudraCT Number )
CTR20171112 ( Registry Identifier: Center for drug evaluation, CFDA )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party BeiGene
Study Sponsor  ICMJE BeiGene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Caicun Zhou, PhD Shanghai Pulmonary Hospital, Shanghai, China
PRS Account BeiGene
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP