Trial record 2 of 61 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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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 |
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Recruitment Status :
Active, not recruiting
First Posted : December 2, 2017
Last Update Posted : May 19, 2021
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Sponsor:
BeiGene
Information provided by (Responsible Party):
BeiGene
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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 |
| 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 30, 2021 |
| Estimated Study Completion Date : | December 30, 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
Drug Information available for:
Docetaxel
| Arm | Intervention/treatment |
|---|---|
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Experimental: BGB-A317
100 mg per vial, 200mg intravenous (IV), Q3W
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Drug: Tislelizumab
Intravenous injection (Anti-PD-1 monoclonal antibody)
Other Name: BGB-A317 |
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Experimental: Docetaxel
75 mg/m2 IV Q3W
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Drug: Docetaxel
Intravenous injection (Antineoplastic, cytotoxic, taxane) |
Primary Outcome Measures :
- Overall survival (OS) in PD-L1+ and all participants (co-primary endpoint) [ Time Frame: Up to 31 months ]
Secondary Outcome Measures :
- 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 ]
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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:
- Age18 years.
- Signed Informed Consent Form.
- 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.
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
- Adequate hematologic and end-organ function.
- Expected life span > 12 weeks.
- Willing to be compliance with birth control requirement during pre-specified study participating period
Key Exclusion Criteria:
- Prior therapies of docetaxel or treatment targeting PD-1, PD-L1 or CTLA-4.
- Harboring EGFR sensitizing mutation or ALK gene translocation.
- 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).
- History of severe hypersensitivity reactions to other mAbs.
- History of interstitial lung disease, non-infectious pneumonitis or participants with significantly impaired pulmonary function, or who require supplemental oxygen at baseline.
- With uncontrollable pleural effusion, pericardial effusion, or clinically significant ascites requiring interventional treatment.
- Active Leptomeningeal disease or uncontrolled, untreated brain metastasis.
- Severe chronic or active infection requiring systemic treatment.
- Known HIV infection, participants with untreated chronic hepatitis B, active vaccination treatment.
- Insufficient cardiac functions and other underlying unfavorable cardiovascular conditions.
- Prior allogeneic stem cell transplantation or organ transplantation.
- Active autoimmune diseases or history of autoimmune diseases that may relapse.
- With conditions requiring systemic treatment with either corticosteroids (>10 mg daily prednisone or equivalent) or other immunosuppressive medications.
- 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
Show 123 study locations
Sponsors and Collaborators
BeiGene
Investigators
| Principal Investigator: | Caicun Zhou, PhD | Shanghai Pulmonary Hospital, Shanghai, China |
| 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: | May 19, 2021 |
| Last Verified: | May 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| 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 |