Efficacy and Safety of CRT, Durvalumab and Surgery for SST

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

September 1, 2020

Primary Completion Date

August 31, 2027

Study Completion Date

August 31, 2030

Conditions
Superior Sulcus TumorNon-small Cell Lung Cancer Stage IIBNon Small Cell Lung Cancer Stage III
Interventions
DRUG

Cisplatin

Cisplatin 60 mg/m2, IV, day 1

DRUG

S1

80 - 120 mg/day, PO, day 1-14

RADIATION

concurrent radiotherapy

66 Gy/33 Fr

DRUG

Durvalumab

preoperative durvalumab therapy within 28 days after chemoradiotherapy. Two courses are given every two weeks.

PROCEDURE

Surgery

Surgery will be performed between day 15 and day 42 of the second course of preoperative durvalumab therapy after confirming that all surgical operation criteria are met.

DRUG

Durvalumab

"(For resectable SST) Postoperative durvalumab therapy will be started between day 28 and day 63 with the day of surgery as Day 1. Twenty-two courses are given as a 2-week course.~Drug: Durvalumab 10 mg/kg/body, IV, day 1 (For unreectable SST) Additional durvalumab therapy between day 15 and day 28 of the second course of preoperative durvalumab therapy.~Twenty-two courses are given as 2-week course. Drug: Durvalumab 10 mg/kg/body, IV, day 1"

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

collaborator

Japan Agency for Medical Research and Development

OTHER_GOV

collaborator

Japan Clinical Oncology Group

OTHER

lead

National Cancer Center Hospital East

OTHER