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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

NCT03358875

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: BGB-A317-303
  • SECONDARY ID: 2018-000245-39
  • SECONDARY ID: CTR20171112
  • NCT ID: NCT03358875

Conditions

  • Non-small Cell Lung Cancer

Interventions

DrugSynonymsArms
Intravenous injection BGB-A317TislelizumabBGB-A317
Intravenous injection DocetaxelDocetaxel

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
BGB-A317ExperimentalBGB-A317, 100 mg per vial, 200mg IV, Q3W
  • Intravenous injection BGB-A317
DocetaxelExperimentalDocetaxel 75 mg/m2 IV Q3W
  • Intravenous injection Docetaxel

Eligibility Criteria

        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

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall survival (OS) in PD-L1+ and all patients (co-primary endpoint)
Time Frame:Up to 34 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Objective response rate(ORR)
Time Frame:Up to 34 months
Safety Issue:
Description:
Measure:Duration of response (DOR)
Time Frame:Up to 34 months
Safety Issue:
Description:
Measure:Progression-free survival (PFS)
Time Frame:Up to 34 months
Safety Issue:
Description:
Measure:Health-related Quality of Life (HRQoL)
Time Frame:Up to 34 months
Safety Issue:
Description:
Measure:Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to NCI-CTCAE, v4.03.
Time Frame:Up to 34 months
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:BeiGene

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