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Trial record 1 of 1 for:    NCT03358875
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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03358875
Recruitment Status : Active, not recruiting
First Posted : December 2, 2017
Last Update Posted : August 12, 2020
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 participants 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: Tislelizumab Drug: Docetaxel Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 805 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 30, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

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

Experimental: Docetaxel
75 mg/m2 IV Q3W
Drug: Docetaxel
Intravenous injection (Antineoplastic, cytotoxic, taxane)




Primary Outcome Measures :
  1. Overall survival (OS) in PD-L1+ and all participants (co-primary endpoint) [ Time Frame: Up to 31 months ]

Secondary Outcome Measures :
  1. Objective response rate(ORR) [ Time Frame: Up to 31 months ]
  2. Duration of response (DOR) [ Time Frame: Up to 31 months ]
  3. Progression-free survival (PFS) [ Time Frame: Up to 31 months ]
  4. Health-related Quality of Life (HRQoL) [ Time Frame: Up to 31 months ]
  5. Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to NCI-CTCAE, v4.03. [ Time Frame: Up to 31 months ]


Information from the National Library of Medicine

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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

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.


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


Locations
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Sponsors and Collaborators
BeiGene
Investigators
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Principal Investigator: Caicun Zhou, PhD Shanghai Pulmonary Hospital, Shanghai, China
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03358875    
Other Study ID Numbers: BGB-A317-303
2018-000245-39 ( EudraCT Number )
CTR20171112 ( Registry Identifier: Center for drug evaluation, CFDA )
First Posted: December 2, 2017    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action