Clinical Trials /

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

NCT03358875

Description:

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.

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

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
  • NCT ID: NCT03358875

Conditions

  • Non-small Cell Lung Cancer

Interventions

DrugSynonymsArms
BGB-A317BGB-A317
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
  • BGB-A317
DocetaxelExperimentalDocetaxel 75 mg/m2 IV Q3W
  • Docetaxel

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

Primary Outcome Measures

Measure:Overall survival (OS)
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

Last Updated

November 27, 2017