Recruiting NCT06692738

A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)

Phase III Interventional Non-small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Rilvegostomig, Pembrolizumab, Carboplatin, Paclitaxel.
Who it may be relevant to: Registry conditions: Non-small Cell Lung Cancer. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Austria, Belgium +21
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung02)

Overview

The purpose of ARTEMIDE-Lung02 is to assess the efficacy and safety of rilvegostomig in combination with platinum-based chemotherapy for the first-line (1L) treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (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 first-line (1L) treatment for patients with squamous locally advanced or metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

Interventions

Drug Rilvegostomig
Administered intravenously (IV) on Day 1 of each 21-day cycle
Drug Pembrolizumab
Administered intravenously (IV) on Day 1 of each 21-day cycle
Drug Carboplatin
Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
Drug Paclitaxel
Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
Drug Nab-paclitaxel
Administered intravenously (IV) on Days 1, 8, and 15 of each 21-day cycle up to 4 cycles

Primary outcome measures

Overall survival (OS) [Time frame: Up to approximately 6 years]
Progression-free survival (PFS) [Time frame: Up to approximately 6 years]

Secondary outcome measures (10)

Landmark overall survival (OS) rates [Time frame: Up to approximately 6 years]
Landmark progression-free survival (PFS) rates [Time frame: Up to approximately 6 years]
Time to second progression or death (PFS2) [Time frame: Up to approximately 6 years]
Overall response rate (ORR) [Time frame: Up to approximately 6 years]
Duration of response (DoR) [Time frame: Up to approximately 6 years]
Pharmacokinetic (PK) of rilvegostomig [Time frame: Up to approximately 6 years]
Immunogenicity of rilvegostomig [Time frame: Up to approximately 6 years]
Patient-reported physical functioning [Time frame: Up to approximately 6 years]
Patient-reported global health status (GHS)/quality of life (QoL) [Time frame: Up to approximately 6 years]
Patient-reported lung cancer symptoms of non-small cell lung cancer (NSCLC) [Time frame: Up to approximately 6 years]

Eligibility criteria

Inclusion criteria

Histologically or cytologically documented squamous NSCLC.
Stage III B/C or IV mNSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.
Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any actionable driver oncogenes for which there are locally approved and available 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.

Exclusion criteria

Presence of small cell and neuroendocrine histology components.
Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 7 days prior to randomization. A minimum of 2 weeks must have elapsed between the end of local therapy (brain radiotherapy or surgery) and randomization. Participants must have recovered from the acute toxic effect of radiotherapy (eg, dizziness and signs of increased intracranial pressure) or surgery prior to randomization.
Any prior systemic, non-curative therapy received for NSCLC.
Any prior treatment with an anti-PD-1 or anti-PD-L1 agent.
Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.
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 systemic treatment with the use of disease-modifying agents or other immunosuppressive drugs.
Active primary immunodeficiency/active infectious disease(s).
Active tuberculosis infection.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment