Resumen

El propósito de este estudio es comprender si PF-08046054 solo funciona bien en comparación con docetaxel solo como tratamiento estándar de atención en participantes con cáncer de pulmón de células no pequeñas (CPCNP) con expresión de PD-L1 mayor o igual al 1% que presentaron progresión del cáncer durante o después del tratamiento con inhibidores de PD-L1 o PD-1, quimioterapia basada en platino y régimen(es) de tratamiento dirigido para participantes con alteraciones genómicas accionables (AGA) conocidas. Los participantes en este estudio deben tener un cáncer que se haya diseminado por su cuerpo o que no pueda extirparse mediante cirugía ni tratarse con radioterapia definitiva. Los participantes serán asignados aleatoriamente (como el lanzamiento de una moneda) al grupo de tratamiento con PF-08046054 o al grupo de tratamiento con docetaxel. Los participantes del grupo de PF-08046054 recibirán una infusión IV (administrada directamente en las venas) dos veces durante cada ciclo de 21 días. Los participantes del grupo de docetaxel recibirán una infusión IV una vez durante cada ciclo de 21 días. La participación en el estudio puede durar hasta 5 años si el CPCNP del participante responde al tratamiento. El equipo del estudio evaluará cómo evoluciona cada participante con el tratamiento del estudio durante las visitas regulares a la clínica.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Histologically or cytologically confirmed diagnosis of NSCLC with locally advanced, unresectable Stage IIIB or IIIC not eligible for definitive chemoradiotherapy or metastatic (Stage IV: M1a, M1b, or M1c) disease per the American Joint Committee on Cancer (AJCC) Staging Manual, Version 8.0, and the Union for International Cancer Control (UICC) Staging System. Note: Participants with a neuroendocrine component or histology are not eligible.
PD-L1 expression on ≥1% of tumor cells based on local immunohistochemistry (IHC) testing with an assay utilizing the anti-PD-L1 monoclonal antibody clones 22C3 or SP263.
Participants who have NSCLC with known AGAs are permitted.
Able to provide any of the following tumor tissues for biomarker analysis:
Archival specimen (preferably collected within 12 months after the last anticancer therapy) (see laboratory manual for details); or
De novo biopsy from a tumor lesion, if medically feasible.
Participants must have received the following therapies and progressed during or relapsed after receiving their most recent prior therapy, or have been intolerant to their most recent therapy:
Participants with no known AGAs must fulfill 1 of the following conditions:
Received a platinum-based combination therapy for the treatment of metastatic or recurrent disease, and unless contraindicated, a PD-(L)1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy).
Experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the adjuvant, neoadjuvant, or chemoradiotherapy setting and received a PD-(L)1 monoclonal antibody at any time during the course of treatment.
Participants with known AGAs (eg, EGFR mutations, ALK translocations, or other relevant actionable mutations) must fulfill the following conditions:
Must have received at least 1 relevant AGA-targeted therapy if locally available and, in the opinion of the investigator, additional AGA-targeted therapy is not in the best interest of the participant
Received a platinum-based combination therapy for the treatment of metastatic or recurrent disease, or experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the adjuvant, neoadjuvant, or chemoradiotherapy setting.
May have received PD-(L)1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy).

Criterios de exclusión

History of another malignancy within 3 years before the first dose of PF-08046054, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (eg, 5-year overall survival \[OS\] ≥90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.
Any central nervous system (CNS) lesions, unless definitively treated with CNS-directed local therapy (surgery and/or radiotherapy). Participants with definitively treated brain metastases are eligible if they meet the following criteria:
The participant is on a stable dose of ≤10 mg/day of prednisone or equivalent for at least \>14 days prior to randomization (if requiring steroid treatment).
No clinical or radiographic progression in the CNS following CNS-directed definitive radiotherapy and/or surgery.
Time since CNS-directed treatment is ≥28 days prior to randomization.
Participants with a history of leptomeningeal metastasis are excluded.
Prior treatment with an anti-PD-L1 agent (where indicated per protocol) within 5 half-lives.
Previous receipt of an MMAE-containing agent or prior docetaxel.

PADL1NK-005: Estudio aleatorizado, de fase 3, abierto, para evaluar PF-08046054/SGN-PDL1V versus docetaxel en participantes adultos con cáncer de pulmón de células no pequeñas (CPCNP) positivo para el ligando 1 de muerte celular programada (PD-L1) previamente tratado

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

PF-08046054

Docetaxel monotherapy

Ubicaciones

Fundación Respirar

Patrocinadores

Contactos

Pfizer CT.gov Call Center