UPCC 08525 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) (ARTEMIDELung04)

Investigational Medications for Metastatic Non-small Cell Lung Cancer with PD-L1 Expression

Enrolling By Invitation
18 years or above
All
Phase 3
830 participants needed
1 Location

Brief description of study

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.

Detailed description of study

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab as a 1L treatment for patients with mNSCLC whose tumors express PD-L1.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Carcinoma, Non-Small Cell Lung
  • Age: 18 years or above
  • Gender: All

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.

This study investigates the use of investigational medications for treating metastatic non-small cell lung cancer (mNSCLC) in patients whose tumors express PD-L1. The purpose of this study is to compare the effectiveness and safety of two treatments: one investigational medication and a standard treatment, pembrolizumab. Participants will be randomly assigned to one of these two study arms to determine which treatment works better for this specific type of lung cancer.

Participants in the study will undergo various procedures. They will be required to provide a tumor sample for central testing before being randomly assigned to a treatment arm. The study will involve regular assessments to monitor the size of the tumors using imaging techniques like CT or MRI scans. The study aims to see how the treatments affect the tumor size and the overall health of the participants.

  • Who can participate: Adults with stage IV metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 can participate. Key eligibility criteria include no prior systemic therapy for advanced mNSCLC, no history of organ transplant, and adequate organ function.
  • Study details: Participants will be randomly assigned to receive either the investigational medication or pembrolizumab. They will undergo regular imaging tests to measure the tumor size. The study will monitor for any changes in health or side effects.
Updated on 14 May 2026. Study ID: 25-1333
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