Studieoverzicht

Study name: 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 Metastatic Squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung02)

Histology	NSCLC, only squamous
Tumor stage	Stage III - IV
NCT Id	NCT06692738
Host / recruiting site 1	Ziekenhuis Gelderse Vallei	Enrollment	Recruiting
Host / recruiting site 2	Isala Zwolle	Enrollment	Recruiting
Host / recruiting site 3	NWZ	Enrollment	Recruiting
Therapy line	First line (1L)
PD-L1 expression	Low: 1 - 49%High: ≥50%
Design	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).
Intervention	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
Key outcome parameters	Overall survival (OS) Progression-free survival (PFS)
Key inclusion criteria	Histologically or cytologically documented squamous NSCLC. Stage 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 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.
Key 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 therapy received for advanced or mNSCLC. 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 treatment with steroids or other immunosuppressive treatment. Active primary immunodeficiency/active infectious disease(s). Active tuberculosis infection.
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