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)
Lung Cancer
Unknown Primary
18 Years and older, Male and Female
D702BC00001 (primary)
2024-514281-39-00 ( Registry Identifier ) (REGISTR
Summary
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).
Objectives
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%).
Eligibility
- 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.
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