Studieoverzicht

Study name: 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

Histology	NSCLC, only non-squamousNSCLC, only squamous
Tumor stage	Stage III - IV
NCT Id	NCT07361497
Host / recruiting site 1	Amphia	Enrollment	Planned
Host / recruiting site 2	UMC Groningen	Enrollment	Recruiting
Host / recruiting site 3	Radboud UMC	Enrollment	Planned
Host / recruiting site 4	Amsterdam UMC	Enrollment	Recruiting
Therapy line	Later line (≥2L)
PD-L1 expression	Negative: <1%Low: 1 - 49%High: ≥50%
Design	A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)
Intervention	DRUG: Pumitamig Specified dose on specified days DRUG: Durvalumab Specified dose on specified days
Key inclusion criteria	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.
Key exclusion criteria	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.
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