USO 24171
A Phase III, Randomized, Double-Blind, Multicenter, Global Study of Rilvegostomig in Combination with Chemotherapy for First-line Treatment of Patients with Metastatic Non-squamous Non-Small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung03). (D702FC00001)
Disease Types: Lung Cancer Research
Eligibility Requirements:
-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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