What side effects are associated with this type of intervention?

Common treatments for NSCLC, such as immune checkpoint inhibitors like pembrolizumab, atezolizumab, and nivolumab, are associated with a range of side effects. These can include immune-related adverse events (irAEs) such as pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Treatment-related grade 3 or 4 adverse events are also common and can include severe fatigue, diarrhea, and elevated liver enzymes. Specific to atezolizumab, grade 3/4 adverse events occurred in 27% to 30% of patients, with pneumonia and chronic obstructive pulmonary disease being notable. Pembrolizumab combined with chemotherapy has shown improved outcomes but also increased the incidence of severe adverse events like neutropenia and febrile neutropenia.

What prior FDA approvals exist?

Several FDA-approved treatments for Non-Small Cell Lung Cancer (NSCLC) involve immunotherapies targeting PD-1 or PD-L1 pathways, similar to the investigational rilvegostomig (AZD2936). Pembrolizumab, a PD-1 inhibitor, has been approved for use in combination with chemotherapy or as monotherapy in patients with PD-L1 expression. Atezolizumab, a PD-L1 inhibitor, has also been approved in combination with chemotherapy for advanced NSCLC. Cemiplimab, another PD-1 inhibitor, is approved for patients with high PD-L1 expression. These treatments have shown efficacy in improving overall survival and progression-free survival in various clinical trials.

What other types of research exist?

Promising alternatives to Rilvegostomig (AZD2936) for NSCLC patients include: 1) Rovalpituzumab Tesirine (Rova-T) in combination with Nivolumab plus or minus Ipilimumab, which targets DLL3 and has shown efficacy in previously treated extensive-stage SCLC. 2) Pembrolizumab, a PD-1 inhibitor, which has been approved for advanced NSCLC with at least 1% PD-L1 expression and has demonstrated durable responses. 3) Nivolumab, another PD-1 inhibitor, which is used in various combinations and has shown benefits in advanced NSCLC. These alternatives offer different mechanisms of action and have shown potential in clinical settings.

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Monoclonal Antibodies

AZD2936 for Non-Small Cell Lung Cancer (ARTEMIDE-01 Trial)

Phase 1 & 2

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

ECOG performance status of 0 or 1 at enrolment

Stage IV squamous or non-squamous NSCLC not amenable to curative surgery or radiation

Must not have

Other invasive malignancy within 2 years prior to screening

Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up part b, c, e: from first dose of rilvegostomig to pd or death in the absence of disease progression (approximately 2 years). part d: from randomization to pd or death in the absence of disease progression (approximately 2 years).

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new medicine that helps the immune system fight severe lung cancer by stopping the cancer from hiding. It is aimed at adults with advanced lung cancer that cannot be removed by surgery.

Who is the study for?

Adults with advanced or metastatic non-small cell lung cancer (NSCLC) that can't be removed by surgery or cured with radiation, and who have seen their cancer progress after treatment. They must not have certain genetic mutations treatable by other drugs, no recent serious blood clots, no other cancers in the last 2 years, and no previous anti-TIGIT therapy.

What is being tested?

The trial is testing AZD2936, a new bispecific antibody targeting two immune checkpoints: TIGIT and PD-1. It's for people whose NSCLC has worsened despite current treatments. The study aims to find out if this drug is safe and effective at controlling their cancer.

What are the potential side effects?

Potential side effects of AZD2936 may include typical reactions related to immune checkpoint inhibitors such as fatigue, skin reactions, inflammation in various organs like lungs or intestines (colitis), hormonal gland problems (endocrinopathies), liver inflammation (hepatitis), and infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or restricted in physically strenuous activity but can do light work.

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My stage IV lung cancer cannot be cured with surgery or radiation.

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I am 18 years old or older.

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I have not received immunotherapy for my lung cancer.

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My lung cancer cannot be removed by surgery or cured with radiation.

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My cancer progressed despite treatment with CPI.

Exclusion Criteria

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

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I have not had any other cancer besides this one in the last 2 years.

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I am not currently receiving any cancer treatments.

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I have symptoms from cancer spread to my brain.

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My cancer has specific changes in the EGFR gene or ALK fusion.

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I have been treated with anti-TIGIT therapy before.

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My cancer did not respond to 2 treatments that included a CPI.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ part b, c, e: from first dose of rilvegostomig to pd or death in the absence of disease progression (approximately 2 years). part d: from randomization to pd or death in the absence of disease progression (approximately 2 years).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~part b, c, e: from first dose of rilvegostomig to pd or death in the absence of disease progression (approximately 2 years). part d: from randomization to pd or death in the absence of disease progression (approximately 2 years).

This trial's timeline: 3 weeks for screening, Varies for treatment, and part b, c, e: from first dose of rilvegostomig to pd or death in the absence of disease progression (approximately 2 years). part d: from randomization to pd or death in the absence of disease progression (approximately 2 years). for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Objective Response Rate (ORR)

Percentage of participants with adverse events (AEs) and immune mediated AEs (imAEs), serious AEs (SAEs), dose limiting toxicities (DLTs), vital signs, and abnormal laboratory parameters

Rate of rilvegostomig discontinuation due to toxicity

Secondary study objectives

Disease control rate (DCR)

Durable response rate (DRR)

Duration of response (DoR)

+8 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

5Treatment groups

Experimental Treatment

Group I: Dose Expansion Part E: treatment Naive Squamous NSCLCExperimental Treatment1 Intervention

Rilvegostomig IV monotherapy

Group II: Dose Expansion Part D: CPI Naive NSCLCExperimental Treatment1 Intervention

Rilvegostomig IV monotherapy

Group III: Dose Expansion Part C: CPI Naive NSCLCExperimental Treatment1 Intervention

Rilvegostomig IV monotherapy

Group IV: Dose Expansion Part B: CPI experienced NSCLCExperimental Treatment1 Intervention

Rilvegostomig IV monotherapy

Group V: Dose Escalation Part A: Checkpoint inhibitor (CPI) experienced Non-small Cell Lung Cancer (NSCLC)Experimental Treatment1 Intervention

Rilvegostomig Intravenous (IV) monotherapy

0 / 12Eligibility 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

Common treatments for Non-Small Cell Lung Cancer (NSCLC) often involve immune checkpoint inhibitors, which target proteins like PD-1, PD-L1, and CTLA-4 to enhance the immune system's ability to recognize and destroy cancer cells. This mechanism is crucial for NSCLC patients as it provides a more targeted and effective treatment option, potentially improving survival rates and reducing disease progression compared to traditional chemotherapy. The investigational drug rilvegostomig (AZD2936), an anti-TIGIT/anti-PD-1 bispecific antibody, exemplifies this approach by simultaneously targeting two immune checkpoints, potentially offering even greater efficacy.

Efficacy and safety of pembrolizumab/carrelizumab, alone or in combination with chemotherapy in treatment of patients with non-small cell lung cancer: A protocol for evidence-based systematic review and Bayesian network meta-analysis.Randomized, phase III trial of figitumumab in combination with erlotinib versus erlotinib alone in patients with nonadenocarcinoma nonsmall-cell lung cancer.