A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Non-squamous NSCLC

Phase 3

Recruiting

• Conditions: Non-squamous Non-small Cell Lung Cancer
• Interventions: Drug: Rilvegostomig; Drug: Pembrolizumab; Drug: Carboplatin; Drug: Cisplatin; Drug: Pemetrexed

• Registration Number: NCT06627647
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of ARTEMIDE-Lung03 is to evaluate the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line treatment of patients with non-squamous mNSCLC 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, both in combination with platinum-based doublet chemotherapy, as a 1L treatment for patients with non-squamous mNSCLC whose tumors express PD-L1 (TC ≥ 1%).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-10-03
• Study First Submitted QC: 2024-10-03
• Study First Posted: 2024-10-04
• Study Start: 2024-11-27
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-17
• Primary Completion: 2029-05-14
• Study Completion: 2030-03-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 878

Inclusion Criteria

• Histologically or cytologically documented non-squamous NSCLC.
• Stage IV mNSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.
• Absence of sensitizing EGFR mutations (including, but not limited to, exon 19 deletion and exon 21 L858R, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations) and ALK and ROS1 rearrangements.
• 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 therapies.
• Provision of acceptable tumor sample, to confirm tumor PD-L1 expression TC ≥ 1%.
• At least one lesion not previously irradiated that qualifies as a RECIST 1.1 TL 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 or MRI and is suitable for accurate repeated measurements.
• Adequate organ and bone marrow function

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Exclusion Criteria

• 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. A minimum of 2 weeks must have elapsed between the end of brain radiotherapy and study enrollment. Participants must have recovered from the acute toxic effect of radiotherapy (eg, dizziness and signs of increased intracranial pressure).
• Any prior systemic therapy received for advanced or mNSCLC. Prior systemic therapy in the neoadjuvant or adjuvant setting and/or definitive radio- or chemoradiotherapy for early-stage disease are allowed, provided that recurrence or progression has occurred > 12 months after the end of treatment.
• Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.
• Any prior treatment with an anti-PD-1 or anti-PD-L1 agent.
• 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.
• Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
• Active primary immunodeficiency/active infectious disease(s).
• Active tuberculosis infection.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Rilvegostomig	Rilvegostomig in combination with platinum-based doublet chemotherapy followed by rilvegostomig monotherapy plus pemetrexed in maintenance.
Arm A	Carboplatin	Rilvegostomig in combination with platinum-based doublet chemotherapy followed by rilvegostomig monotherapy plus pemetrexed in maintenance.
Arm A	Cisplatin	Rilvegostomig in combination with platinum-based doublet chemotherapy followed by rilvegostomig monotherapy plus pemetrexed in maintenance.
Arm A	Pemetrexed	Rilvegostomig in combination with platinum-based doublet chemotherapy followed by rilvegostomig monotherapy plus pemetrexed in maintenance.
Arm B	Pembrolizumab	Pembrolizumab in combination with platinum-based doublet chemotherapy followed by pembrolizumab monotherapy plus pemetrexed in maintenance.
Arm B	Carboplatin	Pembrolizumab in combination with platinum-based doublet chemotherapy followed by pembrolizumab monotherapy plus pemetrexed in maintenance.
Arm B	Cisplatin	Pembrolizumab in combination with platinum-based doublet chemotherapy followed by pembrolizumab monotherapy plus pemetrexed in maintenance.
Arm B	Pemetrexed	Pembrolizumab in combination with platinum-based doublet chemotherapy followed by pembrolizumab monotherapy plus pemetrexed in maintenance.

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).
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 progression event), after the start of the first subsequent therapy, or death from any cause, whichever occurs first. The date of the second progression will be recorded by the investigator in the eCRF and defined according to local standard clin...
Overall 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).
Pharmacokinetic (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 global health status (GHS)/quality of life (QoL)	Up to approximately 5 years	TTD of GHS/QoL as measured by the EORTC IL172. TTD is defined as time from randomization to the date of first deterioration.
Patient-reported physical functioning	Up to approximately 5 years	Proportion of participants with maintained or improved physical functioning as measured by PROMIS PF-SF 8c - 7 day at each time point.
Patient-reported lung cancer symptoms of non-small cell lung cancer (NSCLC)	Up to approximately 5 years	TTD in pulmonary symptoms as measured by the NSCLC-SAQ. TTD is defined as time from randomization to the date of first deterioration.

Trial Locations

Locations (1)

Research Site; 🇻🇳 Vinh, Vietnam