Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer (NSCLC)

• ClinicalTrials.gov Identifier: NCT04379635
• Recruitment Status: Active, not recruiting
• First Posted: May 7, 2020
• Last Update Posted: March 2, 2023
• Sponsor: BeiGene
• Information provided by (Responsible Party): BeiGene

Tracking Information

• First Submitted Date: May 4, 2020
• First Posted Date: May 7, 2020
• Last Update Posted Date: March 2, 2023
• Actual Study Start Date: May 29, 2020
• Estimated Primary Completion Date: June 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 5, 2020)

• Major pathological response (MPR) in Intent-to-Treat (ITT) analysis set [ Time Frame: Up to 3 months following completion of neoadjuvant treatment ]
• Event-free survival (EFS) in ITT analysis set as Assessed by the Blinded Independent Central Review (BICR) [ Time Frame: Up to 5 years ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 5, 2020)

• Overall survival (OS) in the ITT set [ Time Frame: Up to 5 years ]
• Pathological complete response (pCR) rate [ Time Frame: Up to 5 years ]
• Objective Response Rate (ORR) [ Time Frame: Up to 5 years ]
• Disease-Free Survival (DFS) in ITT analysis set [ Time Frame: Up to 5 years ]
• Event-free survival (EFS) Assessed by the Investigator [ Time Frame: Up to 5 years ]
• Number of participants experiencing treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 5 years ]
• Efficacy and Safety as Assessed by Health-related quality of life (HRQoL) Questionnaire [ Time Frame: Up to 5 years ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer (NSCLC)
• Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy and Safety of Neoadjuvant Treatment With Tislelizumab (BGB-A317, Anti-PD-1 Antibody) or Placebo Plus Platinum-Based Doublet Chemotherapy Followed By Adjuvant Tislelizumab or Placebo in Resectable Stage II or IIIA Non-Small Cell Lung Cancer
• Brief Summary: The primary objective of this study is to evaluate and compare major pathological response(MPR) rate and event-free survival (EFS) in participants receiving tislelizumab plus platinum-based doublet chemotherapy as the new additional treatment followed by tislelizumab as adjuvant treatment versus participants receiving placebo plus platinum-based doublet chemotherapy as neoadjuvant treatment followed by placebo as adjuvant treatment.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Non Small Cell Lung Cancer

Intervention

• Drug: Tislelizumab
  administered via Intravenous (IV) injection
  Other Name: BGB-A317
• Drug: Cisplatin injection
  administered via IV infusion
• Drug: Paclitaxel injection
  administered via IV infusion
• Drug: Pemetrexed Disodium
  administered via IV infusion
• Drug: Placebos
  Placebo to match tislelizumab IV infusion
• Drug: Carboplatin
  administered via IV infusion

Study Arms

• Experimental: Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Tislelizumab
  Tislelizumab + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium
  Interventions:

  • Drug: Tislelizumab
  • Drug: Cisplatin injection
  • Drug: Paclitaxel injection
  • Drug: Pemetrexed Disodium
  • Drug: Carboplatin
• Placebo Comparator: Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Placebo
  Placebo + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium
  Interventions:

  • Drug: Cisplatin injection
  • Drug: Paclitaxel injection
  • Drug: Pemetrexed Disodium
  • Drug: Placebos
  • Drug: Carboplatin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: September 6, 2022): 453
• Original Estimated Enrollment (submitted: May 5, 2020): 380
• Estimated Study Completion Date: November 2025
• Estimated Primary Completion Date: June 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Key Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
2. Histologically confirmed Stage II or IIIA NSCLC
3. Measurable disease as assessed per RECIST v1.1
4. Confirm eligibility for an R0 resection with curative intent

Key Exclusion Criteria:

1. Any prior therapy for current lung cancer, including chemotherapy, or radiotherapy
2. Known Epidermal growth factor receptor (EGFR) mutation or Anaplastic Lymphoma Kinase (ALK) gene translocation
3. Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days before randomization
4. Active autoimmune diseases or history of autoimmune diseases that may relapse
5. History of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc.

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: China

Administrative Information

• NCT Number: NCT04379635
• Other Study ID Numbers: BGB-A317-315; CTR20200821 ( Registry Identifier: ChiCTR )
• 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

• Current Responsible Party: BeiGene
• Original Responsible Party: Same as current
• Current Study Sponsor: BeiGene
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Changli Wang, MD; Tianjin Medical University Cancer Institute and Hospital

• PRS Account: BeiGene
• Verification Date: March 2023