A Study of Ociperlimab With Tislelizumab Compared to Pembrolizumab in Participants With Untreated Lung Cancer

• ClinicalTrials.gov Identifier: NCT04746924
• Recruitment Status: Recruiting
• First Posted: February 10, 2021
• Last Update Posted: March 28, 2023
• Sponsor: BeiGene
• Information provided by (Responsible Party): BeiGene

Tracking Information

• First Submitted Date: February 5, 2021
• First Posted Date: February 10, 2021
• Last Update Posted Date: March 28, 2023
• Actual Study Start Date: June 8, 2021
• Estimated Primary Completion Date: January 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 25, 2022)

• Progression-free Survival (PFS) As Assessed By Investigators [ Time Frame: Up to approximately 40 months ]
  PFS will be defined as the time from the date of randomization to the date of the first objectively documented tumor progression per RECIST v1.1, or death, whichever occurs first.
• Overall Survival (OS) [ Time Frame: Up to approximately 40 months ]
  OS will be defined as the time from the date of randomization to the date of death due to any cause.

Original Primary Outcome Measures (submitted: February 5, 2021)

• Progression-free Survival (PFS) As Assessed By Investigators [ Time Frame: Up to approximately 39 months ]
  PFS will be defined as the time from the date of randomization to the date of the first objectively documented tumor progression per RECIST v1.1, or death, whichever occurs first.
• Overall Survival (OS) As Assessed By Investigators [ Time Frame: Up to approximately 39 months ]
  OS will be defined as the time from the date of randomization to the date of death due to any cause.

Current Secondary Outcome Measures (submitted: October 25, 2022)

• PFS As Assessed By A Blinded Independent Review Committee [ Time Frame: Up to approximately 40 months ]
  PFS will be defined as the time from the date of randomization to the date of the first objectively documented tumor progression per RECIST v1.1, or death, whichever occurs first.
• Overall Response Rate (ORR) As Assessed By Investigators [ Time Frame: Up to approximately 40 months ]
  ORR will be defined as the proportion of participants with a documented, confirmed complete response or partial response per RECIST v1.1.
• Duration Of Response (DOR) As Assessed By Investigators [ Time Frame: Up to approximately 40 months ]
  DOR will be defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of progression or death, whichever occurs first.
• Health-related Quality Of Life (HRQoL): European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire Core 30 (EORTC QLQ-C30) [ Time Frame: Within 7 days after permanent treatment discontinuation ]
  HRQoL will be assessed via patient-reported outcomes (PRO) using the EORTC QLQ-C30. The EORTC QLQ-C30 (Version 3) consists of Global health status/QoL (score range from 0=very poor to 7=excellent), 5 functioning scales (physical, role, emotional, cognitive, social), 8 symptom scales (fatigue, nausea/vomiting, pain, dyspnea, insomnia, constipation, diarrhea) and financial difficulties with scores ranging from 1 = "Not at all" to 4 = "Very much". For the global health status/QoL and functioning scales, higher scores indicate better outcomes and for symptom scales, lower scores indicate better outcomes.
• HRQoL: EORTC Lung Cancer Module Quality of Life Questionnaire Lung Cancer 13 (QLQ-LC13) HRQoL will be assessed via PRO using the EORTC QLQ-LC13. [ Time Frame: Within 7 days after permanent treatment discontinuation ]
  QLQ-LC13 consists of 10 scales, scores ranging from 1 = "not at all" to 4 = "very much", and 2 questions regarding use of pain medication (yes/no) and if yes, did it help (1 = "not at all" to 4 = "very much"). In symptom scales, lower scores indicate better outcomes.
• HRQoL: European Quality of Life-5 Level- 5 Dimension (EQ-5D-5L) Questionnaire [ Time Frame: Within 7 days after permanent treatment discontinuation ]
  HRQoL will be assessed via PRO using the EQ-5D-5L. The EQ-5D-5L comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, and a visual analog scale (VAS). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The VAS records the respondent's self-rated health on a 0 to 100 scale, with 100 = "the best health you can imagine" and 0 = "'the worst health you can imagine". Lower scores in descriptive dimension indicate better HRQoL and higher VAS scores indicates better health state.
• Time To Deterioration (TTD) [ Time Frame: Within 7 days after permanent treatment discontinuation ]
  TTD will be analyzed using PRO scores, and will be defined as worsening scores of ≥10 points from baseline for 2 consecutive assessments or 1 assessment followed by death from any cause.
• Number Of Participants Experiencing Adverse Events (AEs) [ Time Frame: 90 days (±14) after last dose ]
  The incidence and severity of AEs will be determined according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0).

Original Secondary Outcome Measures (submitted: February 5, 2021)

• PFS As Assessed By A Blinded Independent Review Committee [ Time Frame: Up to approximately 39 months ]
  PFS will be determined.
• Overall Response Rate (ORR) As Assessed By Investigators [ Time Frame: Up to approximately 39 months ]
  ORR will be defined as the proportion of participants with a documented, confirmed complete response or partial response per RECIST v1.1.
• Duration Of Response (DOR) As Assessed By Investigators [ Time Frame: Up to approximately 39 months ]
  DOR will be defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of progression or death, whichever occurs first.
• Health-related Quality Of Life (HRQoL): European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) [ Time Frame: Within 7 days after last dose ]
  HRQoL will be assessed via patient-reported outcomes (PRO) using the EORTC QLQ-C30.
• HRQoL: EORTC Lung Cancer Module Quality Of Life Questionnaire Lung Cancer 13 (QLQ-LC13) [ Time Frame: Within 7 days after last dose ]
  HRQoL will be assessed via PRO using the EORTC QLQ-LC13.
• HRQoL: The 5 Level EuroQol 5 Dimension (EQ-5D-5L) Questionnaire [ Time Frame: Within 7 days after last dose ]
  HRQoL will be assessed via PRO using the EQ-5D-5L.
• Time To Deterioration (TDD) [ Time Frame: Within 7 days after last dose ]
  TDD will be analyzed using the global health status of QLQ-C30 and will be defined as worsening scores for 2 consecutive assessments or 1 assessment followed by death from any cause.
• Number Of Participants Experiencing Adverse Events (AEs) [ Time Frame: 90 days (±14) after last dose ]
  The incidence and severity of AEs will be determined according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0).

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

Descriptive Information

• Brief Title: A Study of Ociperlimab With Tislelizumab Compared to Pembrolizumab in Participants With Untreated Lung Cancer
• Official Title: A Phase 3, Randomized, Double-Blind Study of Ociperlimab, an Anti-TIGIT Antibody, in Combination With Tislelizumab Compared to Pembrolizumab in Patients With Previously Untreated, PD-L1-Selected, and Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer
• Brief Summary: The purpose of the study is to compare progression-free survival (PFS) between Arm A (ociperlimab in combination with tislelizumab) and Arm B (pembrolizumab in combination with placebo) as assessed by investigators according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) and to compare overall survival (OS) between Arm A and Arm B.
• 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
• NSCLC

Intervention

• Drug: Tislelizumab
  Tislelizumab is a monoclonal antibody formulated for intravenous injection.
  Other Name: BGB-A317
• Drug: Ociperlimab
  Ociperlimab is a monoclonal antibody formulated for intravenous injection.
  Other Name: BGB-A1217
• Drug: Pembrolizumab
  Pembrolizumab is a monoclonal antibody formulated for intravenous injection.
  Other Name: KEYTRUDA
• Drug: Placebo
  Placebo infusions will consist of a sterile, normal saline solution.

Study Arms

• Experimental: Arm A: Tislelizumab plus Ociperlimab
  Participants will receive tislelizumab 200 milligrams (mg) intravenously followed by ociperlimab 900 mg intravenously once every 3 weeks.
  Interventions:

  • Drug: Tislelizumab
  • Drug: Ociperlimab
• Active Comparator: Arm B: Pembrolizumab plus Placebo
  Participants will receive pembrolizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks.
  Interventions:

  • Drug: Pembrolizumab
  • Drug: Placebo
• Placebo Comparator: Arm C: Tislelizumab plus Placebo
  Participants will receive tislelizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks.
  Interventions:

  • Drug: Tislelizumab
  • Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 25, 2022): 660
• Original Estimated Enrollment (submitted: February 5, 2021): 605
• Estimated Study Completion Date: May 2025
• Estimated Primary Completion Date: January 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Key Inclusion Criteria:

1. Histologically or cytologically documented locally advanced or recurrent non-small cell lung cancer (NSCLC) that is not eligible for curative surgery and/or definitive radiotherapy with or without chemoradiotherapy, or metastatic-nonsquamous or squamous NSCLC.
2. No prior systemic treatment for metastatic NSCLC.
3. Agreement to provide archival tissue or fresh biopsy (if archival tissue is not available).
4. Tumors with PD-L1 expressed in ≥ 50% tumor cells.
5. At least 1 measurable lesion as defined per RECIST v1.1.
6. ECOG Performance Status ≤ 1.

Key Exclusion Criteria:

1. Known mutations in the epidermal growth factor receptor (EGFR) gene, anaplastic lymphoma kinase (ALK) fusion oncogene, BRAF V600E, or ROS1.
2. Prior therapy with an anti-programmed cell death protein (anti-PD)-1, anti-PD-ligand (L)-1, anti-PD-ligand-2, anti-T-cell immunoglobulin and ITIM (anti-TIGIT) domain, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.
3. Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
4. Active autoimmune diseases or history of autoimmune diseases that may relapse.

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: BeiGene; 1-877-828-5568; clinicaltrials@beigene.com

• Listed Location Countries: Australia, China, France, Georgia, Germany, Italy, Japan, Korea, Republic of, Netherlands, Poland, Russian Federation, Spain, Taiwan, Thailand, Turkey, Ukraine, United States

Administrative Information

• NCT Number: NCT04746924
• Other Study ID Numbers: AdvanTIG-302; BGB-A317-A1217-302 ( Other Identifier: BeiGene )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• 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: Shun Lu; Shanghai Chest Hospital
• Principal Investigator: Mark Socinski; Advent Health Orlando

• PRS Account: BeiGene
• Verification Date: March 2023