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

Phase 3

Active, not recruiting

• Conditions: Non-small Cell Lung Cancer; NSCLC
• Interventions: Drug: Tislelizumab; Drug: Pembrolizumab; Drug: Placebo; Drug: Ociperlimab

• Registration Number: NCT04746924
• Lead Sponsor: BeiGene

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-05
• Study First Submitted QC: 2021-02-05
• Study First Posted: 2021-02-10
• Study Start: 2021-06-08
• Primary Completion: 2025-05-30
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-23
• Last Update Posted: 2025-06-24
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 662

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A: Tislelizumab plus Ociperlimab	Tislelizumab	Participants will receive tislelizumab 200 milligrams (mg) intravenously followed by ociperlimab 900 mg intravenously once every 3 weeks.
Arm B: Pembrolizumab plus Placebo	Pembrolizumab	Participants will receive pembrolizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks.
Arm B: Pembrolizumab plus Placebo	Placebo	Participants will receive pembrolizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks.
Arm C: Tislelizumab plus Placebo	Tislelizumab	Participants will receive tislelizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks.
Arm C: Tislelizumab plus Placebo	Placebo	Participants will receive tislelizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks.
Arm A: Tislelizumab plus Ociperlimab	Ociperlimab	Participants will receive tislelizumab 200 milligrams (mg) intravenously followed by ociperlimab 900 mg intravenously once every 3 weeks.

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Up to approximately 58 months	OS will be defined as the time from the date of randomization to the date of death due to any cause.

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS) As Assessed By Investigators	Up to approximately 58 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	Up to approximately 58 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	Up to approximately 58 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)	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.	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	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)	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)	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).

Trial Locations

Locations (218)

Centro Medical Austral; 🇦🇷 Buenos Aires, Argentina

Concord Repatriation General Hospital; 🇦🇺 Concord, New South Wales, Australia

Northern Cancer Institute; 🇦🇺 St Leonards, New South Wales, Australia

Calvary Mater Newcastle; 🇦🇺 Waratah, New South Wales, Australia

The Prince Charles Hospital; 🇦🇺 Chermside, Queensland, Australia

John Flynn Private Hospital; 🇦🇺 Tugun, Queensland, Australia

Cancer Institute of Ceara; 🇧🇷 Fortaleza, Brazil

Cepho Centro de Estudos E Pesquisas de Hematologia E Oncologia; 🇧🇷 Santo Andre, Brazil

Fujian Cancer Hospital; 🇨🇳 Fuzhou, Fujian, China

The First Affiliated Hospital of Xiamen University; 🇨🇳 Xiamen, Fujian, China

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