Rilvegostomig or Pembrolizumab for Non-Small Cell Lung Cancer

(ARTEMIDELung04 Trial)

Recruiting at 87 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of ARTEMIDE-Lung04 is to assess the efficacy and safety of rilvegostomig compared with pembrolizumab monotherapy as 1L treatment in participants with mNSCLC and whose tumors express PD-L1.

Eligibility Criteria

This trial is for individuals with advanced non-small cell lung cancer that has high levels of a protein called PD-L1. Participants should not have had prior treatments for their metastatic cancer.

Inclusion Criteria

Minimum life expectancy of 12 weeks

My organs and bone marrow are working well.

My lung cancer has been confirmed by lab tests.

Exclusion Criteria

My brain metastases are stable, and I haven't needed steroids or seizure medicine for 4 weeks.

I do not have severe illnesses that would prevent me from following the study's requirements.

I have had an organ transplant.

Treatment Details

Interventions

• Pembrolizumab (PD-L1 Inhibitor)
• Rilvegostomig (PD-L1 Inhibitor)

Trial Overview The study is testing the effectiveness and safety of two drugs: Rilvegostomig and Pembrolizumab. Each participant will receive one of these as a first-line treatment to compare which works better.

Participant Groups

Group I: Arm A Experimental Treatment 1 Intervention

Drug: rilvegostomig

Group II: Arm B Active Control 1 Intervention

Drug: Pembrolizumab

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology