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Checkpoint Inhibitor

Ociperlimab + Tislelizumab vs Pembrolizumab for Lung Cancer

Phase 3

Recruiting

Led By Mark Socinski, MD

Research Sponsored by BeiGene

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Tumors with PD-L1 expressed in ≥ 50% tumor cells.

ECOG Performance Status ≤ 1.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 58 months

Awards & highlights

Study Summary

This trial is comparing two different cancer treatments to see which one is more effective in terms of progression-free survival and overall survival.

Who is the study for?

This trial is for adults with advanced or recurrent non-small cell lung cancer (NSCLC) that can't be treated with surgery/radiotherapy, or metastatic NSCLC. Participants must have tumors where PD-L1 is present in at least 50% of cells and at least one measurable lesion. They should be relatively fit (ECOG ≤ 1), able to provide tissue samples, and not have had previous treatments for metastatic NSCLC.Check my eligibility

What is being tested?

The study compares two groups: Arm A receives Ociperlimab plus Tislelizumab, while Arm B gets Pembrolizumab with a placebo. The main focus is on how long patients live without their disease getting worse (PFS) and overall survival time (OS), following standard tumor measurement criteria.See study design

What are the potential side effects?

Possible side effects include immune-related reactions affecting organs, infusion-related symptoms, fatigue, skin issues, hormonal gland problems like thyroid dysfunction, liver inflammation, and potential complications from the body's immune response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tumor shows high PD-L1 expression.

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I am fully active and can carry on all my pre-disease activities without restriction.

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My lung cancer cannot be cured with surgery or radiotherapy.

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I agree to provide tissue samples for the study.

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I haven't received any systemic treatment for my advanced lung cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 58 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 58 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 58 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival (OS)

Secondary outcome measures

Duration Of Response (DOR) As Assessed By Investigators

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.

HRQoL: European Quality of Life-5 Level- 5 Dimension (EQ-5D-5L) Questionnaire

+5 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Arm A: Tislelizumab plus OciperlimabExperimental Treatment2 Interventions

Participants will receive tislelizumab 200 milligrams (mg) intravenously followed by ociperlimab 900 mg intravenously once every 3 weeks.

Group II: Arm B: Pembrolizumab plus PlaceboActive Control2 Interventions

Participants will receive pembrolizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks.

Group III: Arm C: Tislelizumab plus PlaceboPlacebo Group2 Interventions

Participants will receive tislelizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tislelizumab

2018

Completed Phase 3

~4260

Ociperlimab

2021

Completed Phase 2

~530

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

BeiGeneLead Sponsor

175 Previous Clinical Trials

28,154 Total Patients Enrolled

Mark Socinski, MDPrincipal InvestigatorAdvent Health Orlando

2 Previous Clinical Trials

636 Total Patients Enrolled

Shun LuPrincipal InvestigatorShanghai Chest Hospital

7 Previous Clinical Trials

1,325 Total Patients Enrolled

Media Library

Ociperlimab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04746924 — Phase 3

Non-Small Cell Lung Cancer Research Study Groups: Arm B: Pembrolizumab plus Placebo, Arm C: Tislelizumab plus Placebo, Arm A: Tislelizumab plus Ociperlimab

Non-Small Cell Lung Cancer Clinical Trial 2023: Ociperlimab Highlights & Side Effects. Trial Name: NCT04746924 — Phase 3

Ociperlimab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04746924 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other areas of research in which Ociperlimab has been used?

"Ociperlimab was first researched in 2010 at City of Hope. As of now, 18490 studies have been completed. Out of the 1107 studies currently underway, many are based in Honolulu, Hawaii."

Answered by AI

When can patients in the US expect to have access to Ociperlimab?

"Ociperlimab's safety has been well documented in prior trials, so it received a score of 3."

Answered by AI

How has Ociperlimab helped patients in the past?

"Ociperlimab can be used to treat various aggressive forms of cancer such as malignant neoplasms and unresectable melanoma."

Answered by AI

Are patients currently being sought for this research project?

"From what is available on clinicaltrials.gov, this study is looking for more patients as of right now. The listing for the clinical trial was first put up on June 8th, 2021 and was updated on October 25th, 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "A Study of Ociperlimab With Tislelizumab Compared to Pembrolizumab in Participants With Untreated Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04746924.

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