NCT04465968

Efficacy and Safety of CRT, Durvalumab and Surgery for SST

Efficacy and Safety of Durvalumab Before and After Operation or Durvalumab as Maintenance Therapy After Chemoradiotherapy Against Superior Sulcus Non-small Cell Lung Cancer

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: National Cancer Center Hospital East · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The safety and efficacy of multimodality treatment of pre- and post-operative durvalumab therapy after pre-operative chemoradiotherapy for resectable superior sulcus tumor (SST) and durvalumab maintenance therapy after chemoradiotherapy for unresectable SST

Detailed description

To evaluate the safety and efficacy of multimodality treatment of pre- and post-operative durvalumab therapy after pre-operative chemoradiotherapy for resectable superior sulcus tumor (SST) and durvalumab maintenance therapy after chemoradiotherapy for unresectable SST

Conditions

• Superior Sulcus Tumor
• Non-small Cell Lung Cancer Stage IIB
• Non Small Cell Lung Cancer Stage III

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-09-01
• Primary completion: 2027-08-31
• Completion: 2030-08-31
• First posted: 2020-07-10
• Last updated: 2020-07-10