RecruitingPhase 3

A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer

A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab Monotherapy for the First-line Treatment of Patients With PD-L1-high Metastatic Non-small Cell Lung Cancer (ARTEMIDE-Lung04)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares rilvegostomig with pembrolizumab, each used alone as a first treatment. It tests how well they work and how safe they are for people with non-small cell lung cancer that has spread and has high levels of a protein called PD-L1.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have non-small cell lung cancer confirmed by testing tissue or cells.
  • Have stage IV cancer that has spread and cannot be treated to cure it.
  • Have no qualifying EGFR, ALK, or ROS1 gene changes. Negative tests are required for all types other than squamous cell cancer.
  • Have no known other cancer gene changes found through usual local testing that have a locally approved targeted first treatment.
  • Be fully active or able to do light work, with no decline in activity during the past 2 weeks.
  • Be expected to live at least 12 weeks and have organs and bone marrow that work well enough.
  • Provide a suitable tumor sample for testing before being assigned a study treatment.
  • Have at least one cancer spot not treated with radiation that can be measured repeatedly on CT or MRI scans. It must be at least 10 mm across, or 15 mm across its shorter side if it is a lymph node.

Who can't join

  • Have a severe or uncontrolled illness that the study doctor thinks would make joining unsafe or make study rules hard to follow.
  • Have had an organ transplant.
  • Have a current or past illness involving inflammation or the immune system attacking the body that requires long-term steroids or other immune-suppressing drugs.
  • Have had another cancer, unless it was treated to cure it, has had no known active disease for at least 2 years, and has a low risk of returning.
  • Have lung cancer that includes small cell or neuroendocrine cancer cells.
  • Have cancer in the brain, unless it is stable, causes no symptoms, and has needed no steroids or seizure medicines for at least 4 weeks before study treatment.
  • Have an active immune deficiency, meaning a weakened immune system, or an active infection, including tuberculosis.
  • Have had drug treatment that works throughout the body for advanced or spread lung cancer, or prior anti-TIGIT, anti-PD-1, anti-PD-L1, or other cancer treatment aimed at immune-control systems.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Histologically or cytologically documented NSCLC (non small lung cancer), including all histological subtypes. * Stage IV mNSCLC (metastatic non-small cell lung cancer) (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment. * Absence of sensitizing EGFR (epidermal growth factor) mutations and ALK (anaplastic lymphoma kinase) and ROS1 (c-ros oncogene 1) rearrangements. Negative assay result is required for all non-squamous histology subtypes. * Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted 1L (first line) therapies. * WHO (World Health Organization)/ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1, with no deterioration over the previous 2 weeks prior to baseline at screening and prior to randomization. * Minimum life expectancy of 12 weeks. * Provision of acceptable tumor sample for the central testing prior to randomization. * At least one lesion not previously irradiated that qualifies as a RECIST 1.1 (Response Evaluation Criteria in Solid Tumors, Version 1.1) TL (target lesion) at baseline and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with CT (computed tomography) or MRI (magnetic resonance imaging) and is suitable for accurate repeated measurements. * Adequate organ and bone marrow function Exclusion Criteria: * As judged by the investigator, any severe or uncontrolled systemic diseases, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol. * History of organ transplant. * Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment. * History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence. * Presence of small cell and neuroendocrine histology components. * Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 4 weeks prior to start of study intervention. * Active primary immunodeficiency/active infectious disease(s) * Active tuberculosis infection * Any prior systemic therapy received for advanced or mNSCLC (metastatic non-small cell lung cancer). * Any prior exposure to an anti-TIGIT (T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domain) therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms. * Any prior treatment with an anti-PD-1 (programmed cell death protein 1) or anti-PD-L1 (anti-programmed death-ligand 1) agent.

Study sites (39)

CA

DE

FL

GA

IA

IL

KS

KY

MD

MI

MO

NE

NJ

NV

NY

OH

PA

TX

WA

WI

WV