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

• ClinicalTrials.gov Identifier: NCT03358875
• Recruitment Status: Active, not recruiting
• First Posted: December 2, 2017
• Last Update Posted: August 12, 2020
• Sponsor: BeiGene
• Information provided by (Responsible Party): BeiGene

Tracking Information

• First Submitted Date: November 27, 2017
• First Posted Date: December 2, 2017
• Last Update Posted Date: August 12, 2020
• Actual Study Start Date: November 30, 2017
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 19, 2020): Overall survival (OS) in PD-L1+ and all participants (co-primary endpoint) [ Time Frame: Up to 31 months ]
• Original Primary Outcome Measures (submitted: November 27, 2017): Overall survival (OS) [ Time Frame: Up to 34 months ]

Current Secondary Outcome Measures (submitted: June 19, 2020)

• 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 ]

Original Secondary Outcome Measures (submitted: November 27, 2017)

• Objective response rate(ORR) [ Time Frame: Up to 34 months ]
• Duration of response (DOR) [ Time Frame: Up to 34 months ]
• Progression-free survival (PFS) [ Time Frame: Up to 34 months ]
• Health-related Quality of Life (HRQoL) [ Time Frame: Up to 34 months ]
• Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to NCI-CTCAE, v4.03. [ Time Frame: Up to 34 months ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• 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.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Non-small Cell Lung Cancer

Intervention

• Drug: Tislelizumab
  Intravenous injection (Anti-PD-1 monoclonal antibody)
  Other Name: BGB-A317
• Drug: Docetaxel
  Intravenous injection (Antineoplastic, cytotoxic, taxane)

Study Arms

• Experimental: BGB-A317
  100 mg per vial, 200mg intravenous (IV), Q3W
  Intervention: Drug: Tislelizumab
• Experimental: Docetaxel
  75 mg/m2 IV Q3W
  Intervention: Drug: Docetaxel

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: April 20, 2020): 805
• Original Estimated Enrollment (submitted: November 27, 2017): 640
• Estimated Study Completion Date: June 2021
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil, Bulgaria, China, Lithuania, Mexico, New Zealand, Poland, Russian Federation, Slovakia, Turkey

Administrative Information

• NCT Number: NCT03358875
• Other Study ID Numbers: BGB-A317-303; 2018-000245-39 ( EudraCT Number ); CTR20171112 ( Registry Identifier: Center for drug evaluation, CFDA )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes

• Responsible Party: BeiGene
• Study Sponsor: BeiGene
• Collaborators: Not Provided

Investigators

• Principal Investigator: Caicun Zhou, PhD; Shanghai Pulmonary Hospital, Shanghai, China

• PRS Account: BeiGene
• Verification Date: August 2020