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

AstraZeneca

Status and phase: Begins enrollment this month; Phase 3

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Nab-paclitaxel; Drug: Pembrolizumab; Drug: Paclitaxel; Drug: Rilvegostomig; Drug: Carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06692738

D702BC00001

2024-514281-39-00 (Other Identifier)

Details and patient eligibility

About

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 metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1).

Full 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 metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

Enrollment: 880 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically documented squamous non-small cell lung cancer (NSCLC).
• Stage IV metastatic non-small cell lung cancer (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 targeted first-line (1L) therapies.
• Provision of acceptable tumor sample to confirm tumor programmed death-ligand 1 (PD-L1) expression tumor cells (TC) ≥ 1%.
• At least one lesion not previously irradiated that qualifies as a Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) target lesion (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 computed tomography (CT) or magnetic resonance imaging (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 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 metastatic non-small cell lung cancer (mNSCLC).
• Prior treatment with an anti-programmed cell death protein 1 (anti-PD-1) or anti-programmed death-ligand 1 (anti-PD-L1) agent.
• Any prior exposure to an anti-T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domain (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 treatment with steroids or other immunosuppressive treatment.
• Active primary immunodeficiency/active infectious disease(s).
• Active tuberculosis infection.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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880 participants in 2 patient groups

Arm A

Experimental group

Description:

Rilvegostomig in combination with carboplatin and paclitaxel or nab-paclitaxel followed by rilvegostomig

Treatment:

Drug: Carboplatin

Drug: Rilvegostomig

Drug: Paclitaxel

Drug: Nab-paclitaxel

Arm B

Active Comparator group

Description:

Pembrolizumab in combination with carboplatin and paclitaxel or nab-paclitaxel followed by pembrolizumab

Treatment:

Drug: Carboplatin

Drug: Paclitaxel

Drug: Pembrolizumab

Drug: Nab-paclitaxel