WCLC 2025 - Posters & ePosters-P3.18.35 ARTEMIDE-Lung02: A Phase 3 Global Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for 1L Metastatic Squamous NSCLC

P3.18.35 ARTEMIDE-Lung02: A Phase 3 Global Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for 1L Metastatic Squamous NSCLC

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The ARTEMIDE-Lung02 study is a global, phase 3, randomized, double-blind clinical trial evaluating rilvegostomig versus pembrolizumab, each combined with platinum-based chemotherapy, as first-line treatment for adults with metastatic squamous non-small cell lung cancer (NSCLC) expressing PD-L1 (tumor cell expression ≥1%). Squamous NSCLC constitutes up to 30% of lung cancers, is strongly linked to smoking, and remains prevalent globally, especially in lower-income countries. Current standard care employs PD-1/PD-L1 immune checkpoint inhibitors (ICIs) with chemotherapy, but not all patients respond effectively, leaving an unmet need.<br /><br />Rilvegostomig is a bispecific monoclonal antibody blocking both PD-1 and TIGIT, two co-inhibitory receptors on T cells, potentially enhancing anti-tumor immune responses beyond PD-1 inhibition alone. Early trials have shown promising activity for rilvegostomig monotherapy in NSCLC.<br /><br />This trial plans to enroll approximately 880 patients across 25–30 countries, including Asia-Pacific, Europe, and the Americas. Eligible participants are adults with stage IV metastatic squamous NSCLC without actionable driver mutations and with good performance status. Patients are randomized 1:1 to receive either rilvegostomig or pembrolizumab, each administered intravenously every three weeks alongside carboplatin plus paclitaxel or nab-paclitaxel chemotherapy for four cycles. After 12 weeks, chemotherapy is stopped and immunotherapy is continued until disease progression or intolerance.<br /><br />Dual primary endpoints are overall survival (OS) and progression-free survival (PFS), with secondary endpoints including objective response rate, duration of response, safety, and patient-reported outcomes. The study began enrollment in November 2024 with expected completion in October 2029. Results are pending.<br /><br />This trial addresses the need for improved therapies for metastatic squamous NSCLC by exploring dual immune checkpoint targeting (PD-1 and TIGIT) with rilvegostomig plus chemotherapy compared to the current standard pembrolizumab-based regimen, potentially improving outcomes for patients who do not benefit from PD-1 inhibition alone.<br /><br />For more information, visit ClinicalTrials.gov (NCT06692738).

Asset Subtitle

T.Jeroen Hiltermann

Meta Tag

Speaker T.Jeroen Hiltermann

Topic Clinical Trials in Progress

Keywords

ARTEMIDE-Lung02

rilvegostomig

pembrolizumab

metastatic squamous non-small cell lung cancer

NSCLC

PD-L1 expression

PD-1 and TIGIT dual inhibition

phase 3 clinical trial

platinum-based chemotherapy

immune checkpoint inhibitors