ROSETTA Lung-201: Un estudio de fase 3, aleatorizado, multicéntrico, abierto de pumitamig en monoterapia comparado con durvalumab en participantes con CPCNP en estadio III irresecable sin progresión tras quimiorradioterapia concurrente basada en platino.

Aún no reclutaFase 3ClinicalTrials.gov

ID: NCT07361497Tipo: INTERVENTIONALInicio: 9 de abr de 2026Fin estimado: 31 de dic de 2033

Resumen

Estudio para evaluar pumitamig versus durvalumab tras quimiorradioterapia concurrente en participantes con cáncer de pulmón de células no pequeñas (CPCNP) en estadio III irresecable.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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 chemotherapy (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.

Criterios de exclusión

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.

Intervenciones

drug

Pumitamig

Specified dose on specified days

drug

Durvalumab

Specified dose on specified days

Ubicaciones

Local Institution - 0093

Buenas Aires, Buenos Aires, Argentina

Site 0093

Local Institution - 0082

Mar del Plata, Buenos Aires, Argentina

Site 0082

Local Institution - 0097

Rosario, Santa Fe Province, Argentina

Site 0097

Local Institution - 0094

Buenos Aires, Argentina

Site 0094

Local Institution - 0078

Buenos Aires, Argentina

Site 0078

Local Institution - 0761

Buenos Aires, Argentina

Site 0761

Local Institution - 0608

Córdoba, Argentina

Site 0608

Local Institution - 0313

Córdoba, Argentina

Site 0313

Patrocinadores

PrincipalBristol-Myers Squibb

ColaboradorBioNTech SE

Contactos

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

Clinical.Trials@bms.com 855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

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