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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up part b, c: 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

ARTEMIDE-01 Trial Summary

This trial is testing a new cancer drug to see if it is safe and effective for people with lung cancer.

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.Check my eligibility
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.See study design
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.

ARTEMIDE-01 Trial 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.

ARTEMIDE-01 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part b, c: 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: 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Disease control rate (DCR)
Durable response rate (DRR)
Duration of response (DoR)
+8 more

ARTEMIDE-01 Trial Design

4Treatment groups
Experimental Treatment
Group I: Dose Expansion Part D: CPI Naive NSCLCExperimental Treatment1 Intervention
Rilvegostomig IV monotherapy
Group II: Dose Expansion Part C: CPI Naive NSCLCExperimental Treatment1 Intervention
Rilvegostomig IV monotherapy
Group III: Dose Expansion Part B: CPI experienced NSCLCExperimental Treatment1 Intervention
Rilvegostomig IV monotherapy
Group IV: Dose Escalation Part A: Checkpoint inhibitor (CPI) experienced Non-small Cell Lung Cancer (NSCLC)Experimental Treatment1 Intervention
Rilvegostomig Intravenous (IV) monotherapy

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,261 Previous Clinical Trials
288,593,979 Total Patients Enrolled

Media Library

AZD2936 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04995523 — Phase 1 & 2
Non-Small Cell Lung Cancer Research Study Groups: Dose Escalation Part A: Checkpoint inhibitor (CPI) experienced Non-small Cell Lung Cancer (NSCLC), Dose Expansion Part B: CPI experienced NSCLC, Dose Expansion Part C: CPI Naive NSCLC, Dose Expansion Part D: CPI Naive NSCLC
Non-Small Cell Lung Cancer Clinical Trial 2023: AZD2936 Highlights & Side Effects. Trial Name: NCT04995523 — Phase 1 & 2
AZD2936 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04995523 — Phase 1 & 2

Frequently Asked Questions

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

What is the current sample size for participants in this trial?

"Affirmative, the current status of the study according to clinicaltrials.gov is actively recruiting participants. This medical research was initially presented on September 14th 2021 and has since been updated as recent as November 16th 2022. A total of 147 individuals are expected to be recruited from 4 distinct sites."

Answered by AI

Are there any unfilled opportunities for patients to join this clinical trial?

"Clinicaltrials.gov reveals that this clinical trial is currently enrolling patients, having first been listed on September 14th 2021 and most recently updated November 16th 2022."

Answered by AI

What is the goal of this scientific investigation?

"The primary endpoint of this clinical trial, which is expected to last for around two years, will measure the rate at which patients discontinue AZD2936 due to toxicity. Secondary objectives include analysis of the drug's pharmacokinetic clearance, objective response rate (ORR), and progression-free survival (PFS)."

Answered by AI

Which demographic is ideal for inclusion in the trial?

"To qualify for this clinical trial, patients are required to have nsclc and be between 18-130 years old. An approximate total of 147 individuals need to partake in the study."

Answered by AI

Does this trial include individuals aged 65 and above?

"This medical trial is seeking to enrol individuals aged 18 or above, but not exceeding 130 years old."

Answered by AI

In what ways is this experiment being administered across multiple facilities?

"Presently, 4 centres are enrolling participants in this clinical trial. These sites can be found across Rochester, Chicago and Orange as well as a few other areas. It is best to select the closest medical centre to avoid any unnecessary travel if accepted into the scheme."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC
2021. "A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04995523.
~78 spots leftby Jan 2026
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