What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC), particularly those involving dual immune checkpoint inhibition like ociperlimab and tislelizumab, often lead to immune-related adverse events. These include pneumonitis, colitis, hepatitis, endocrinopathies (such as hypothyroidism and hyperthyroidism), and skin reactions like rash and pruritus. When combined with chemotherapy, additional side effects such as neutropenia, anemia, and fatigue are more frequent. Severe adverse events, though rarer, can include severe pneumonitis, myocarditis, and infusion-related reactions.

What prior FDA approvals exist?

The FDA has approved several immune checkpoint inhibitors for the treatment of Non-Small Cell Lung Cancer (NSCLC). Pembrolizumab (Keytruda) and Nivolumab (Opdivo) are PD-1 inhibitors approved for various stages of NSCLC, often in combination with chemotherapy. Atezolizumab (Tecentriq), a PD-L1 inhibitor, is also approved for NSCLC, either alone or in combination with chemotherapy. Durvalumab (Imfinzi), another PD-L1 inhibitor, is approved for patients with stage III NSCLC whose disease has not progressed following concurrent chemoradiotherapy. These approvals highlight the effectiveness of targeting the PD-1/PD-L1 pathway in NSCLC treatment, similar to the dual immune checkpoint inhibition approach being studied with Ociperlimab and Tislelizumab.

What other types of research exist?

Promising alternatives to Ociperlimab and Tislelizumab for NSCLC patients include: 1) Pembrolizumab (anti-PD-1) combined with chemotherapy, which has shown improved OS and PFS in patients with PD-L1 expression. 2) Atezolizumab (anti-PD-L1) combined with chemotherapy, particularly for patients with high PD-L1 expression. 3) Nivolumab (anti-PD-1) combined with Ipilimumab (anti-CTLA-4), which has shown efficacy in some NSCLC subgroups. These alternatives have demonstrated significant clinical benefits and are supported by robust clinical trial data.

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Chemotherapy

Ociperlimab + Tislelizumab for Non-Small Cell Lung Cancer

Phase 3

Waitlist Available

Research Sponsored by BeiGene

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization through to the end of study, planned duration was 20 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing two treatments for a specific type of lung cancer that hasn't worsened after initial therapy. One treatment combines two drugs, ociperlimab and tislelizumab, while the other uses Durvalumab. Both treatments aim to help the immune system fight the cancer more effectively.

Who is the study for?

This trial is for adults with Stage III unresectable non-small cell lung cancer who've completed at least 2 cycles of platinum-based chemo with radiotherapy and haven't progressed post-treatment. They must have good performance status, adequate organ function, and provide tissue samples. Excluded are those with prior PD-1/PD-L1 pathway treatment, active autoimmune diseases, certain infections or unresolved toxicities from previous treatments.

What is being tested?

The study compares progression-free survival between two arms: Arm A receives Ociperlimab plus Tislelizumab; Arm C gets Durvalumab after concurrent chemoradiotherapy. The goal is to see which combination works better in preventing the cancer from progressing.

What are the potential side effects?

Potential side effects include immune-related reactions such as inflammation in various organs, infusion-related symptoms like fever or chills, fatigue, possible digestive issues and an increased risk of infection due to immune system suppression.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization through to the end of study, planned duration was 20 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization through to the end of study, planned duration was 20 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization through to the end of study, planned duration was 20 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

Progression-Free Survival (PFS) as Assessed by the Independent Review Committee (IRC)

Secondary study objectives

Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status

Change From Baseline in Health Related Quality of Life (HRQoL) as Assessed by European Quality of Life-5 Dimensions (EQ-5D-5L)

Change From Baseline in Health Related Quality of Life (HRQoL) as Assessed by Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13)

+11 more

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT03015129

65%

Fatigue

63%

Abdominal pain

55%

Diarrhea

43%

Pain

40%

Weight loss

35%

Hypertension

30%

Anorexia

30%

Constipation

28%

Nausea

28%

Pruritus

25%

Vomiting

20%

Dyspnea

20%

Urinary tract infection

18%

Rash maculo-papular

15%

Cough

15%

Abdominal Pain

15%

Back pain

15%

Increased Urinary Frequency

15%

Weight gain

13%

Arthralgia

10%

Dizziness

10%

Anxiety

10%

Bladder infection

10%

Nasal congestion

10%

Vaginal discharge

Colitis

Dry mouth

Dry skin

Fever

Anal pain

Edema limbs

Flatulence

Headache

Hot flashes

Myalgia

Small intestinal obstruction

Thromboembolic event

Urinary frequency

Urinary tract pain

Confusion

Renal and urinary disorders - Other, specify

Adrenal insufficiency

Anemia

Ascites

Gastroesophageal reflux disease

Hypomagnesemia

Lymphedema

Memory impairment

Mucositis oral

Pneumonitis

Rash acneiform

Sinus bradycardia

Upper respiratory infection

Urinary urgency

Vaginal hemorrhage

Alanine aminotransferase increased

Aspartate aminotransferase increased

Alkaline phosphatase increased

Colonic perforation

Dysarthria

Blood bilirubin increased

CPK increased

Creatinine increased

Myositis

Rectal hemorrhage

Hypothyroidism

Left ventricular systolic dysfunction

Lethargy

Muscle weakness left-sided

Myocarditis

Rectal pain

Weight Loss

Fall

Generalized muscle weakness

Hyperglycemia

Hyperkalemia

Pain in extremity

Peripheral sensory neuropathy

Pleural effusion

Skin infection

100%

80%

60%

40%

20%

Study treatment Arm

Durvalubmab

Durvalubmab + Tremelimumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: cCRT followed by DurvalumabExperimental Treatment3 Interventions

Participants enrolled under PA1 recieved two cycles of cCRT, followed by durvalumab to 1 year after the cCRT phase

Group II: Tislelizumab + cCRTExperimental Treatment3 Interventions

Participants enrolled under PA1 recieved two cycles of tislelizumab combined with cCRT, followed by tislelizumab up to 1 year after the cCRT phase

Group III: Ociperlimab + Tislelizumab + cCRTExperimental Treatment4 Interventions

Participants enrolled under PA1 recieved two cycles of ociperlimab combined with tislelizumab and cCRT, followed by ociperlimab combined with tislelizumab up to 1 year after the cCRT phase

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Chemotherapy

2003

Completed Phase 4

~3050

Radiotherapy

2017

Completed Phase 3

~2610

Durvalumab

FDA approved

Tislelizumab

Not yet FDA approved

Ociperlimab

2021

Completed Phase 2

~1300

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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

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include immune checkpoint inhibitors such as anti-PD-1 (e.g., pembrolizumab, nivolumab), anti-PD-L1 (e.g., atezolizumab, durvalumab), and anti-CTLA-4 (e.g., ipilimumab) therapies. These treatments work by blocking proteins that inhibit the immune system's ability to attack cancer cells. Specifically, PD-1 and PD-L1 inhibitors prevent the interaction between PD-1 receptors on T-cells and PD-L1 on tumor cells, thereby enhancing the immune response against the cancer. CTLA-4 inhibitors work by blocking the CTLA-4 protein on T-cells, which also enhances immune activation. For NSCLC patients, these therapies are crucial as they can lead to improved progression-free survival and overall survival by enabling the immune system to more effectively target and destroy cancer cells. The combination of dual immune checkpoint inhibition, such as anti-TIGIT (Ociperlimab) and anti-PD-1 (Tislelizumab), aims to further enhance this immune response, potentially offering better outcomes for patients with advanced NSCLC.

CCTG BR34: A Randomized Phase 2 Trial of Durvalumab and Tremelimumab With or Without Platinum-Based Chemotherapy in Patients With Metastatic NSCLC.Toxicity of radiation and immunotherapy combinations.