The Study of Envafolimab Combined With Concurrent Chemoradiotherapy In LS-SCLC

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

August 1, 2023

Primary Completion Date

December 30, 2026

Study Completion Date

June 30, 2027

Conditions
Lung Neoplasms
Interventions
DRUG

Envafolimab combined with concurrent chemoradiotherapy (Hypofractionated radiotherapy)

"Envafolimab: 300mg SC d1,Q3W,2 cycles Cisplatin/carboplatin: Cisplatin: 75 mg/m2 IV d1,Q3W ,2 cycles or Carboplatin:AUC=5/6 IV d1,Q3W,2cycles Etoposide: 100mg/m2 IV d1,Q3W ,2 cycles Radiotherapy: Provide a prescription dose of 45Gy at a 95% PTV dose, with a single split dose of 3Gy, once a day, 5 times a week, for a total of 15 times.~Envafolimab maintenance: 300mg,SC, d1. Q3W, up to 2 years or until PD or intolerable."

DRUG

Envafolimab combined with concurrent chemoradiotherapy (Conventional Radiotherapy)

"Envafolimab: 300mg SC d1,Q3W,2 cycles Cisplatin/carboplatin:Cisplatin:75 mg/m2 IV d1,Q3W ,2 cycles or Carboplatin:AUC=5/6 IV d1,Q3W,2cycles Etoposide: 100mg/m2 IV d1,Q3W ,2 cycles Radiotherapy: Provide a prescription dose of 60Gy at a 95% PTV dose, with a single split dose of 2Gy, once per day, 5 times per week, for a total of 30 times.~Envafolimab maintenance: 300mg,SC, d1. Q3W, up to 2 years or until PD or intolerable."

All Listed Sponsors
lead

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

NCT05904015 - The Study of Envafolimab Combined With Concurrent Chemoradiotherapy In LS-SCLC | Biotech Hunter | Biotech Hunter