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Efficacy and Safety of CRT, Durvalumab and Surgery for SST

NCT04465968 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2020-07-10

No results posted yet for this study

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

Conditions

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

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Japan Agency for Medical Research and Development

    collaborator OTHER_GOV

  • Japan Clinical Oncology Group

    collaborator OTHER

  • National Cancer Center Hospital East

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2027-08-31
Completion
2030-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04465968 on ClinicalTrials.gov