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.
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 Participants 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
Drug | Synonyms | Arms |
---|
Tislelizumab | BGB-A317 | BGB-A317 |
Docetaxel | | Docetaxel |
Purpose
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.
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.
Trial Arms
Name | Type | Description | Interventions |
---|
BGB-A317 | Experimental | 100 mg per vial, 200mg intravenous (IV), Q3W | |
Docetaxel | Experimental | 75 mg/m2 IV Q3W | |
Eligibility 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.
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 participants (co-primary endpoint) |
Time Frame: | Up to 31 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Objective response rate(ORR) |
Time Frame: | Up to 31 months |
Safety Issue: | |
Description: | |
Measure: | Duration of response (DOR) |
Time Frame: | Up to 31 months |
Safety Issue: | |
Description: | |
Measure: | Progression-free survival (PFS) |
Time Frame: | Up to 31 months |
Safety Issue: | |
Description: | |
Measure: | Health-related Quality of Life (HRQoL) |
Time Frame: | Up to 31 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 31 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | BeiGene |
Last Updated
August 17, 2021