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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 Patients With NSCLC

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ClinicalTrials.gov Identifier: NCT03358875
Recruitment Status : Recruiting
First Posted : December 2, 2017
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
BeiGene

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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Intravenous injection BGB-A317 Drug: Intravenous injection Docetaxel Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 7, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: BGB-A317
BGB-A317, 100 mg per vial, 200mg IV, Q3W
Drug: Intravenous injection BGB-A317
Anti-PD-1 monoclonal antibody
Other Name: Tislelizumab

Experimental: Docetaxel
Docetaxel 75 mg/m2 IV Q3W
Drug: Intravenous injection Docetaxel
Antineoplastic, cytotoxic, taxane
Other Name: Taxotere




Primary Outcome Measures :
  1. Overall survival (OS) in PD-L1+ and all patients (co-primary endpoint) [ 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03358875


Contacts
Contact: Chen Cao +86 10 5895 8000 clinicaltrials@beigene.com

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Sponsors and Collaborators
BeiGene

Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03358875     History of Changes
Other Study ID Numbers: BGB-A317-303
First Posted: December 2, 2017    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Antibodies
Immunoglobulins
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs