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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04746924
• Other study ID #: AdvanTIG-302
• Secondary ID: BGB-A317-A1217-3
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 8, 2021
• Est. completion date: October 2026

Study information

• Verified date: May 2024
• Source: BeiGene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of ociperlimab + tislelizumab compared with that of pembrolizumab in adults with PD-L1 high, locally advanced/recurrent or untreated metastatic NSCLC.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 662
• Est. completion date: October 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer
• NSCLC

Intervention

Drug:
• Tislelizumab
Tislelizumab is a monoclonal antibody formulated for intravenous injection.
• Ociperlimab
Ociperlimab is a monoclonal antibody formulated for intravenous injection.
• Pembrolizumab
Pembrolizumab is a monoclonal antibody formulated for intravenous injection.
• Placebo
Placebo infusions will consist of a sterile, normal saline solution.

Locations

Country	Name	City	State
United States	Virginia Cancer Specialists	Fairfax	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	OS will be defined as the time from the date of randomization to the date of death due to any cause.	Up to approximately 58 months
Secondary	Progression-free Survival (PFS) As Assessed By Investigators	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.	Up to approximately 58 months
Secondary	Overall Response Rate (ORR) As Assessed By Investigators	ORR will be defined as the proportion of participants with a documented, confirmed complete response or partial response per RECIST v1.1.	Up to approximately 58 months
Secondary	Duration Of Response (DOR) As Assessed By Investigators	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.	Up to approximately 58 months
Secondary	Health-related Quality Of Life (HRQoL): European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire Core 30 (EORTC QLQ-C30)	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.	Within 7 days after permanent treatment discontinuation
Secondary	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.	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.	Within 7 days after permanent treatment discontinuation
Secondary	HRQoL: European Quality of Life-5 Level- 5 Dimension (EQ-5D-5L) Questionnaire	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.	Within 7 days after permanent treatment discontinuation
Secondary	Time To Deterioration (TTD)	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.	Within 7 days after permanent treatment discontinuation
Secondary	Number Of Participants Experiencing Adverse Events (AEs)	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).	90 days (±14) after last dose