Study of Treatment With Sacituzumab and Zimberelimab for Patients With Lung Cancer Confined to the Chest and Previously Operated on Who Were Not Disease-free.

PHASE3RecruitingINTERVENTIONAL
Enrollment

129

Participants

Timeline

Start Date

February 4, 2025

Primary Completion Date

November 30, 2031

Study Completion Date

November 30, 2031

Conditions
Lung DiseasesCarcinoma, Non-Small-Cell LungResectable Lung Non-Small Cell Carcinoma
Interventions
DRUG

Zimberelimab

"Zimberelimab is a fully human IgG4 monoclonal antibody targeting human PD-1. PD-1 is a type I transmembrane protein that is part of the immunoglobulin gene superfamily and the CD28 family of cell surface receptors. PD-1 is an inhibitory immune checkpoint protein that is expressed on activated B cells, T cells, and myeloid cells, and it plays a key role in limiting the activity of effector T cells.~Zimberelimab is formulated at 30 mg/mL in a buffer solution containing histidine/histidine-HCl buffer solution, sucrose, sodium chloride, and polysorbate 80, at pH 5.5. The investigational product is supplied as a vial contains 120 mg of active Zimberelimab at a concentration of 30mg/mL.~No premedication nor profilaxis is needed before Zimberelimab administration. Zimberelimab doses are administered by IV infusion over 60 minutes, followed by a 30- to 60-minute observation period, on D1 of each 21-day cycle."

DRUG

Sacituzumab govitecan

"Sacituzumab govitecan (SG) is an ADC composed of the following 3 components:~o The humanized monoclonal antibody hRS7 IgG1κ, which binds to Trop-2, a transmembrane calcium signal transducer that is overexpressed in many epithelial cancers.~o The camptothecin-derived agent SN-38, a topoisomerase I inhibitor. o A hydrolyzable linker, with the company designation as CL2A that links the humanized monoclonal antibody to SN-38.~Sacituzumab govitecan is approved globally for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) and HR+ breast cancer."

DRUG

Cisplatin

"Cisplatin-based adjuvant chemotherapy~Cisplatin - CAS 15663-27-1, is a platinum coordination complex with potent anti-neoplastic activity. Induces apoptosis in cancer cells, possibly via caspase-3 activation."

DRUG

Carboplatin

Cisplatin-based adjuvant chemotherapy Structure: The cis-diamino (cyclobutane-1, 1 dicarboxylate) plating. Stability: 24 hours at ambient temperature in 5% glucose, glucosamine or physiologic saline. It is recommended not to dilute with chlorinated solutions for this could affect the carboplatin. Route of administration: Intravenous infusion. Guidelines of Carboplatin administration: According to the standard of each center. Other Name: ATC code: L01XA02

Trial Locations (30)

11407

RECRUITING

Hospital Universitario Jerez De La Frontera, Jerez de la Frontera

15006

RECRUITING

Hospitalario Universitario A Coruña, A Coruña

24071

RECRUITING

Hospital Universitario de León, León

27003

RECRUITING

Hospital Universitario Lucus Augusti, Lugo

28040

RECRUITING

Hospital Clínico San Carlos, Madrid

RECRUITING

Hospital Universitario Fundación Jiménez Díaz, Madrid

28046

NOT_YET_RECRUITING

Hospital Universitario la Paz, Madrid

28222

RECRUITING

Hospital Universitario Puerta de Hierro, Majadahonda

32005

RECRUITING

Hospital Santa María Nai, Ourense

35010

RECRUITING

Hospital Universitari de Gran Canària Doctor Negrín, Las Palmas de Gran Canaria

36036

RECRUITING

Complejo Hospitalario Universitario de Vigo, Vigo

37007

RECRUITING

Hospital Universitario Salamanca, Salamanca

38009

RECRUITING

Hospital Universitario Nuestra Señora La Candelaria, Santa Cruz de Tenerife

41013

RECRUITING

Hospital Virgen del Rocío, Seville

43204

RECRUITING

Hospital Universitari Sant Joan de Reus, Reus

46010

RECRUITING

Hospital Clínico de Valencia, Valencia

46026

RECRUITING

Hospital Universitario La Fe, Valencia

47003

RECRUITING

Hospital Clínico Universitario de Valladolid, Valladolid

48013

RECRUITING

Hospital De Basurto, Bilbao

03203

NOT_YET_RECRUITING

Hospital General de Elche, Elche

08916

NOT_YET_RECRUITING

ICO Badalona, Hospital Germans Trias i Pujol, Badalona

08908

RECRUITING

ICO Hospitalet, L'Hospitalet de Llobregat

07120

RECRUITING

Hospital de Son Espases, Palma de Mallorca

03010

RECRUITING

Hospital General Universitario de Alicante, Alicante

08035

RECRUITING

Hospital Universitari Vall d' Hebron, Barcelona

08036

RECRUITING

Hospital Clínic De Barcelona, Barcelona

08041

RECRUITING

Hospital de la Santa Creu i Sant Pau, Barcelona

08208

RECRUITING

Hospital Parc Taulí, Barcelona

07198

RECRUITING

Hospital Universitari Son Llatzer, Palma de Mallorca

08227

RECRUITING

Consorci Sanitari de Terrassa, Terrassa

All Listed Sponsors
lead

Fundación GECP

OTHER