Efficacy and Safety of CRT, Durvalumab and Surgery for SST

Sponsor
National Cancer Center Hospital East
Study ID
NCT04465968
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
20 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Cisplatin — DRUG
    Cisplatin 60 mg/m2, IV, day 1
  • S1 — DRUG
    80 - 120 mg/day, PO, day 1-14
  • concurrent radiotherapy — RADIATION
    66 Gy/33 Fr
  • Durvalumab — DRUG
    preoperative durvalumab therapy within 28 days after chemoradiotherapy. Two courses are given every two weeks.
  • Surgery — PROCEDURE
    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.
  • Durvalumab — DRUG
    (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

Study Details

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

Key Dates

Start date
Sep 1, 2020
Status verified
Jul 2020
Primary completion
Aug 31, 2027
Completion
Aug 31, 2030

Study Design

Enrollment
84 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CRT + Durvalumab ± Surgery + Durvalumab
    Concurrent chemoradiotherapy (cisplatin+S-1+radiotherapy 66Gy)+2 courses of durvalumab followed by Surgery and adjuvant durvalumab for resectable SST or chemoradiotherapy (cisplatin+S-1+radiotherapy 66Gy) followed by maintenance durvalumab for unresectable SST.

Primary Outcome Measure

3-year overall survival rate (3y-OS) [ Time Frame: 3 years ]

Central Contacts