Insight (S2414) for Early Stage NSCLC (Non-Small Cell Lung Cancer) - Clinical Trial

¿Cuál es el Propósito de este estudio?

We are doing this study to compare 2 different approaches for patients who have surgery to remove non-small cell lung cancer (NSCLC). We want to see if giving patients an immunotherapy drug called durvalumab (the study drug) after surgery has different outcomes than the usual approach, which is to closely monitor a patient's condition for any changes.

¿Cuál es la Condición que se está estudiando?

Cáncer de pulmón de células no pequeñas (CPCNP)

¿Quién puede participar en el Estudio?

Adults ages 18+ who:

Are diagnosed with stage II-IIIB NSCLC
Have had a complete (R0) resection of NSCLC (with appropriate lymph node sampling as defined by the NCCN Guidelines) no more than 12 weeks before getting a study group assignment
Have had a pathologic complete response to surgery (no viable tumor in the resected specimen or lymph nodes)
Do not have any EGFR mutations or ALK gene fusion

For more information, contact the study team at nick.jeffries@duke.edu.

Grupo etario

Adultos

¿Qué Implica?

Si decide unirse a este estudio, recibirá una asignación aleatoria (como lanzar una moneda al aire) a 1 de 2 grupos:

Group 1: If you are in this group, you will get the study drug. You will get the study drug as an infusion (through a vein in your arm) every 28 days. Each infusion will take about 60 minutes. You will get up to 12 doses of the study drug.
Group 2: If you are in this group, you will receive the usual approach to care after surgery (observation). Your doctor will watch your condition carefully and look for any signs of the cancer returning. You will not receive further treatment unless new signs or symptoms appear.

We will keep in touch with you for up to 10 years to see how you are doing.

Detalles del Estudio

Título Completo

S2414, A Randomized Phase III Trial Incorporating Pathologic Complete Response in Participants with Early Stage Non-Small Cell Lung Cancer to Optimize Immunotherapy in the Adjuvant Setting (INSIGHT) (NCT06498635)

Investigador Principal