What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) using immune checkpoint inhibitors like pembrolizumab, nivolumab, and atezolizumab, which are similar to ociperlimab and tislelizumab, often result in immune-related side effects. These include fatigue, rash, diarrhea, and endocrine disorders such as hypothyroidism. More severe but less frequent side effects can include pneumonitis, hepatitis, colitis, and myocarditis. When combined with chemotherapy, these treatments can also lead to increased rates of neutropenia, anemia, and nausea.

What prior FDA approvals exist?

Several immune checkpoint inhibitors targeting the PD-1/PD-L1 pathway have received FDA approval for the treatment of Non-Small Cell Lung Cancer (NSCLC). Pembrolizumab is approved for patients with PD-L1 expression of ≥1% and has shown improved overall survival (OS) and progression-free survival (PFS) in various trials. Atezolizumab is approved for front-line treatment in patients with high PD-L1 expression (≥50% of tumor cells or ≥10% of tumor-infiltrating immune cells), demonstrating significant OS benefits. Cemiplimab is another PD-1 inhibitor approved for advanced NSCLC with PD-L1 expression of ≥50%, showing improved OS and PFS compared to chemotherapy. These approvals highlight the efficacy of targeting the PD-1/PD-L1 pathway in NSCLC treatment.

What other types of research exist?

Promising alternatives to Ociperlimab + Tislelizumab for NSCLC patients include: 1) Pembrolizumab, which has shown improved OS and PFS in combination with chemotherapy in the KEYNOTE-407 trial, particularly for patients with high PD-L1 expression. 2) Atezolizumab, which demonstrated improved OS in the IMpower 110 trial for patients with high PD-L1 expression. Both options have shown significant efficacy and manageable safety profiles.

Checkpoint Inhibitor

Ociperlimab + Tislelizumab vs Pembrolizumab for Lung Cancer

Tianjin, China

Phase 3

Waitlist Available

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.

Must not have

Known mutations in the epidermal growth factor receptor (EGFR) gene, anaplastic lymphoma kinase (ALK) fusion oncogene, BRAF V600E, or ROS1.

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 58 months

Awards & highlights

Pivotal Trial

Summary

This trial is testing a combination of two drugs, ociperlimab and tislelizumab, to see how well they work together. Tislelizumab is an anti-PD-1 antibody developed by BeiGene, showing promise in various cancers and approved in China for several uses. It targets adults with a specific type of advanced lung cancer that has high levels of a protein called PD-L1. The drugs aim to boost the body's immune system to better recognize and attack cancer cells.

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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.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has specific genetic changes (EGFR, ALK, BRAF V600E, or ROS1).

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I have previously received immunotherapy targeting specific immune checkpoints.

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I have untreated brain metastasis or active disease in the lining of my brain.

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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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival (OS)

Secondary study objectives

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

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Side effects data

From 2023 Phase 2 trial • 125 Patients • NCT04732494

27%

Anaemia

21%

Constipation

18%

Hypothyroidism

16%

Weight decreased

15%

Diarrhoea

15%

Hypoalbuminaemia

15%

Hyponatraemia

13%

Fatigue

13%

Rash

13%

Hypokalaemia

11%

Cough

10%

COVID-19

10%

Lymphocyte count decreased

10%

Decreased appetite

10%

Pruritus

Vomiting

Blood creatine phosphokinase increased

Dyspnoea

Hypertension

Asthenia

Alanine aminotransferase increased

Aspartate aminotransferase increased

Pneumonitis

Gastrooesophageal reflux disease

Nausea

Pyrexia

White blood cell count decreased

Hypercalcaemia

Dizziness

Headache

Insomnia

Productive cough

Cancer pain

Chills

Hyperthyroidism

Oesophageal obstruction

Pneumonia

Blood lactate dehydrogenase increased

Hyperglycaemia

Hyperkalaemia

Hyperuricaemia

Hypocalcaemia

Hypochloraemia

Hypophosphataemia

Arthralgia

Back pain

Pleural effusion

Dermatitis

Dry skin

Neutrophil count decreased

Sinus tachycardia

Abdominal pain

Abdominal pain upper

Dry mouth

Dysphagia

Haemorrhoids

Stomatitis

Oedema peripheral

Upper respiratory tract infection

Blood creatine phosphokinase MB increased

Electrocardiogram high voltage

Platelet count decreased

Hyperchloraemia

Hypernatraemia

Hypomagnesaemia

Hypoproteinaemia

Myalgia

Pain in extremity

Hypoaesthesia

Eczema

Death

Malaise

Chest pain

Angina unstable

Immune-mediated myocarditis

Myocarditis

Pericardial effusion

Tachycardia

Secondary adrenocortical insufficiency

Oesophageal ulcer

Upper gastrointestinal haemorrhage

Sudden death

Bacteraemia

Device related sepsis

Herpes zoster

Pneumonia aspiration

Diabetic ketoacidosis

Respiratory failure

Immune-mediated dermatitis

Hypovolaemic shock

Peripheral arterial occlusive disease

Thrombocytopenia

Non-cardiac chest pain

Blood alkaline phosphatase increased

Blood creatinine increased

Blood urea increased

Neck pain

Dysphonia

Adrenal insufficiency

Hypophysitis

Immune-mediated lung disease

Interstitial lung disease

Tumour haemorrhage

Completed suicide

Delirium

Benign prostatic hyperplasia

Chronic obstructive pulmonary disease

100%

80%

60%

40%

20%

Study treatment Arm

Arm A: Tislelizumab Plus Ociperlimab

Arm B: Tislelizumab Plus Placebo

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Ociperlimab

2021

Completed Phase 2

~1420

Tislelizumab

2018

Completed Phase 3

~4790

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Immune checkpoint inhibitors, such as pembrolizumab, nivolumab, and the combination of ociperlimab and tislelizumab, work by targeting the PD-1/PD-L1 pathway. This pathway normally helps keep the immune system in check by preventing T-cells from attacking the body's own tissues. Cancer cells can exploit this pathway by expressing PD-L1, which binds to PD-1 receptors on T-cells, effectively turning off the immune response against the tumor. By blocking either PD-1 or PD-L1, these drugs release the 'brakes' on the immune system, allowing T-cells to recognize and destroy cancer cells. This mechanism is particularly important for NSCLC patients as it offers a targeted approach to boost the body's own immune response against the cancer, potentially leading to better outcomes and prolonged survival.