ROSETTA Lung-201: A Randomized, Multicenter, Open-label Phase 3 Study of Pumitamig Monotherapy Compared to Durvalumab in Participants with Unresectable Stage III NSCLC Without Progression After Platinum-based Concurrent Chemoradiation Therapy

未提供0 个研究点目标入组 50 人开始时间: 待定

适应症

试验速览

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•Participants must have a histologically- or cytologically-confirmed diagnoses of non-small cell lung cancer (NSCLC) with unresectable Stage III disease.
•Participants must have received at least 2 cycles of platinum-based concurrent chemoradiotherapy (a total dose of radiation of at least 54 Gy).
•Participants must have no progressive disease (PD) following treatment with concurrent chemoradiotherapy (CCRT).
•Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.

•Participants with non-squamous histology must not have documented Epidermal Growth Factor Receptor (EGFR) and anaplastic lymphoma kinase (ALK) rearrangements.
•Participants must not have an active autoimmune disease.
•Participants must not have significant cardiovascular impairment such as uncontrolled hypertension (despite optimal medical treatment), congestive heart failure, active coronary disease (within 6 months prior to randomization), ventricular arrhythmias, major thrombotic or embolic events or major hemorrhagic events within 6 months prior to randomization, or significant risk of pulmonary hemorrhage.
•Participants must not have advanced/clinically significant lung disease (within 6 months prior to randomization) or history of interstitial lung disease (ILD) or pneumonitis requiring treatment with systemic steroids (>=Grade 2), or current or suspected ILD or pneumonitis.
•Participants must not have any prior anticancer therapy (outside of CCRT) for locally advanced Stage III disease.
•Other protocol-defined Inclusion/Exclusion criteria apply.

发起方

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