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

Phase 3

Recruiting

• Conditions: Carcinoma, Non-Small Cell Lung
• Interventions: Biological: Rilvegostomig; Biological: Pembrolizumab

• Registration Number: NCT06868277
• Lead Sponsor: AstraZeneca

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2025-03-07
• Study First Submitted QC: 2025-03-07
• Study First Posted: 2025-03-10
• Study Start: 2025-04-10
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-14
• Primary Completion: 2030-01-17
• Study Completion: 2030-12-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 830

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Rilvegostomig	Drug: rilvegostomig
Arm B	Pembrolizumab	Drug: Pembrolizumab

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Up to approximately 5 years	OS is defined as the time from randomization until the date of death due to any cause.
Progression-Free Survival (PFS)	Up to approximately 5 years	PFS is defined as the time from randomization until radiological progression per RECIST 1.1 or death due to any cause (in the absence of progression).

Secondary Outcome Measures

Name	Time	Method
Landmark Overall Survival (OS) rates	Up to approximately 5 years	OS is defined as the time from randomization until the date of death due to any cause.
Landmark Progression-Free Survival (PFS) rates	Up to approximately 5 years	PFS is defined as the time from randomization until radiological progression per RECIST 1.1 or death due to any cause (in the absence of progression).
Objective Response Rate (ORR)	Up to approximately 5 years	ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, using RECIST 1.1.
Duration of Response (DoR)	Up to approximately 5 years	DoR is defined as the time from the date of first documented response until the date of documented progression using RECIST 1.1 or death due to any cause (in the absence of progression).
Time to second progression or death (PFS2)	Up to approximately 5 years	PFS2 is defined as the time from randomization until the earliest of the progression event (following the initial investigator-assessed progression event), after the start of the first subsequent therapy, or death from any cause, whichever occurs first.
Pharmakokinetics (PK) of rilvegostomig	Up to approximately 5 years	Concentration of rilvegostomig in serum
Immunogenicity of rilvegostomig	Up to approximately 5 years	Presence of antidrug antibodies (ADAs), titer, and neutralizing antibodies for rilvegostomig.
Patient-reported physical functioning	Up to approximately 5 years	Proportion of participants with maintained or improved physical functioning as measured by Patient-Reported Outcomes Measurement Information System Physical Function - Short Form 8c - 7 day (PROMIS PF-SF 8c - 7 day) at each time point.
Patient-reported global health status (GHS)/quality of life (QoL)	Up to approximately 5 years	Time to deterioration (TTD) of GHS/QoL as measured by the European Organization for Research and Treatment of Cancer Item Library 172 (EORTC IL172). TTD is defined as time from randomization to the date of first deterioration.
Patient-reported lung cancer symptoms of non-small cell lung cancer (NSCLC)	Up to approximately 5 years	Time to deterioration (TTD) in pulmonary symptoms as measured by the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ).; TTD is defined as time from randomization to the date of first deterioration.

Trial Locations

Locations (1)

Research Site; 🇬🇧 Blackpool, United Kingdom