A phase 1B/2A, open-label trial evaluating tuvusertib in combination with cemiplimab in patients with non-squamous non-small cell lung cancer that has progressed on prior anti–PD-(L)1 and platinum-based therapies (DDRiver™ NSCLC 322)1
NSCLC
Tuvusertib is an investigational orally administered inhibitor of ataxia telangiectasia and Rad3-related (ATR) protein kinase, a key component of the DNA damage response (DDR) pathway. Based on preclinical studies, tuvusertib is a highly selective and potent inhibitor of ATR activity1-2
Study design | North America, Europe, and Asia
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Please contact us for more information on this trial, including how to enroll your patients
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Tuvusertib is being investigated in this clinical trial and has not been shown to be safe or effective for any purpose or disease. This page describes one of the clinical trials for tuvusertib, and it includes information about how the safety and efficacy of tuvusertib will be measured and evaluated. Therefore, it is important to understand that tuvusertib is not a treatment for cancer or any other disease, its use has not been approved by any health authority, such as the European Medicines Agency or the US Food and Drug Administration, and there is no guarantee that tuvusertib will be approved in the sought-after indication by any health authority worldwide.
a For a list of all inclusion and exclusion criteria, please visit https://clinicaltrials.gov/ct2/show/NCT05882734.
b Tuvusertib will be administered as dosing regimen 1 or 2 until disease progression, death, discontinuation, or any other reason. The selected dosing regimen of tuvusertib will be administered in all arms of phase 2A.
c Cemiplimab will be administered as an intravenous infusion every 3 weeks in all arms of phase 1B and phase 2A until disease progression, death, discontinuation, or any other reason.
d Assessed by investigator per RECIST version 1.1.
ALK, anaplastic lymphoma kinase; ATR, ataxia telangiectasia mutated and Rad3-related; DDR, DNA damage response; DNA, deoxyribonucleic acid; DoR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; EGFR, epidermal growth factor receptor; NSCLC, non-small cell lung cancer; OR, objective response; OS, overall survival; PD-1, programmed cell death 1 protein; PD-L1, programmed cell death 1 ligand 1; PFS, progression-free survival; RECIST, Response Evaluation Criteria in Solid Tumors.
References
1. ClinicalTrials.gov. Accessed June 27, 2024. https://clinicaltrials.gov/study/NCT05882734; 2. Roidos P, et al. Nat Commun. 2020;11(1):4077.
The mechanisms in the DDRiver™ clinical trials program are under clinical investigation and have not been proven to be safe and effective. There is no guarantee that any therapies in the clinical trials program will be approved in the sought-after indication by any health authority worldwide. Clinical trial information is available at www.clinicaltrials.gov.
This website is intended for healthcare professionals in the US and Canada. For patient information, click here: https://clinicaltrials.emdgroup.com/.
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US-MULO-00083 June 2024