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.

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Checkpoint Inhibitor

Ociperlimab + Tislelizumab vs Pembrolizumab for Lung Cancer

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.

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.

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.

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.

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.

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

+5 more

Side effects data

From 2023 Phase 2 trial • 126 Patients • NCT04952597

90%

Anaemia

83%

Nausea

78%

White blood cell count decreased

71%

Alopecia

68%

Neutrophil count decreased

63%

Platelet count decreased

59%

Constipation

54%

Vomiting

51%

Decreased appetite

41%

Radiation oesophagitis

39%

Hyponatraemia

39%

Rash

29%

Hypoalbuminaemia

29%

Cough

27%

Lymphocyte count decreased

22%

Asthenia

22%

Aspartate aminotransferase increased

22%

Hypokalaemia

20%

Pyrexia

20%

Alanine aminotransferase increased

20%

Weight decreased

17%

Productive cough

17%

Fatigue

15%

Diarrhoea

15%

Blood bilirubin increased

15%

Pneumonia

15%

Hyperglycaemia

12%

Arthralgia

12%

Haemoptysis

12%

Hypothyroidism

12%

Malaise

12%

Insomnia

12%

Eczema

10%

Dysphagia

10%

Abdominal distension

10%

Hypertriglyceridaemia

10%

Hypoproteinaemia

10%

Pneumonitis

10%

Dyspepsia

10%

Abdominal pain upper

10%

Dizziness

Thrombocytopenia

Gamma-glutamyltransferase increased

Pruritus

Chest pain

Abdominal pain

Hypochloraemia

Fibrin D dimer increased

Upper respiratory tract infection

Non-cardiac chest pain

Radiation pneumonitis

Hypomagnesaemia

Radiation skin injury

Hypocalcaemia

Dyspnoea

Blood creatinine increased

Oedema peripheral

Toothache

Hyperuricaemia

Blood creatine phosphokinase increased

Malnutrition

Neutropenia

Pain in extremity

Hiccups

Intervertebral disc protrusion

Leukopenia

Back pain

Gastritis

Influenza

Laryngeal pain

Immune-mediated lung disease

Hypotension

Oesophageal perforation

Upper gastrointestinal haemorrhage

Hypercholesterolaemia

Ataxia

Blood fibrinogen increased

C-reactive protein increased

Hypertension

Septic shock

Immune-mediated enterocolitis

Myocardial necrosis marker increased

Pneumonia bacterial

COVID-19 pneumonia

Interstitial lung disease

Sinusitis

Gastrooesophageal reflux disease

Blood urea increased

Oropharyngeal pain

100%

80%

60%

40%

20%

Study treatment Arm

Arm A: Ociperlimab + Tislelizumab

Arm C: Concurrent Chemoradiotherapy (cCRT)

Arm B: Tislelizumab

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

Tislelizumab

2018

Completed Phase 3

~4560

Ociperlimab

2021

Completed Phase 2

~1300

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.