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Clinical Trials List

Protocol NumberD933QC00001
NCT Number(ClinicalTrials.gov Identfier)NCT03703297
Active

2018-10-01 - 2026-12-31

Phase III

Recruiting10

Terminated1

ICD-10C34

Malignant neoplasm of bronchus and lung

ICD-9162.8

Malignant neoplasm of other parts of bronchus or lung

A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients with Stage I-III Limited Disease Small-Cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy (ADRIATIC)

  • Trial Applicant

  • Sponsor

    AstraZeneca

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator CHIN-CHOU WANG Division of Thoracic Medicine
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yuh-Min Chen Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Principal Investigator
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
Chang Gung Medical Foundation Chang Gung Memorial Hospital, Keelung

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 柯政昌 Division of Thoracic Medicine
National Taiwan University Hospital Hsin-Chu Branch

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chung-Yu Chen Division of Thoracic Medicine
National Taiwan University Hospital Yunlin Branch 

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳昭勳 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator kang-Yun LEE Division of Thoracic Medicine
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

2 Recruiting

Audit

CRO

Principal Investigator Wen-Cheng Chang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Taiwan National PI

張文震

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

2 Recruiting

Audit

None

Principal Investigator
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Principal Investigator Chung-Yu Chen Division of General Internal Medicine
國立臺灣大學醫學院附設醫院雲林分院

Co-Principal Investigator

  • 王馨儀 Division of General Internal Medicine

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Small Cell Lung Cancer

Objectives

This is a Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients with LS-SCLC Who Have Not Progressed Following Concurrent Chemoradiation Therapy.

Test Drug

Durvalumab (MEDI4736)

Active Ingredient

Durvalumab (Humanized anti-PD-1 mAb)
Tremelimumab (Humanized anti-CTLA-4 mAb)

Dosage Form

Injection

Dosage

50
20

Endpoints

Primary Outcome Measures:
1. Progression-free survival (PFS).
2. Overall Survival (OS).

Secondary Outcome Measures:
1. Overall Survival (OS).
2. Objective Response Rate (ORR).
3. Progression-free survival PFS.
4. Progression-free survival at 18 months (PFS18).
5. Progression-free survival at 24 months (PFS24).
6. Time to death or distant metastasis (TTDM).
7. Proportion of patients alive at 24 months (OS24).
8. Proportion of patients alive at and 36 months (OS36).
9. Time from randomization to second progression (PFS2).
10. To assess symptoms and health-related QoL in patients treated withdurvalumab or durvalumab and tremelimumab combination therapy compared to placebo using the EORTC QLQ-C30 v3.
11. To assess the PK of durvalumab and tremelimumab in blood (peak trough concentration).
12. Presence of anti-drug antibodies (ADA) for durvalumab and tremelimumab (confirmatory results: positive or negative).
13. PD-L1 expression in tumor and/or immune cells relative to response/efficacy outcomes (PFS, OS & ORR)..
14. To assess symptoms and health-related QoL in patients treated withdurvalumab or durvalumab and tremelimumab combination therapy compared to placebo using the EORTC QLQ-LC13.

Other Outcome Measures:
1. Adverse Events.

Inclution Criteria

1. Histologically or cytologically documented limited-stage small cell lung cancer (stage I-III).
2. Received 4 cycles of chemotherapy concurrent with radiotherapy, which must be completed within 1 to 42 days prior to randomization and the first dose of IP. Chemotherapy must contain platinum and IV etoposide. Radiotherapy must be either total 60-66 Gy over 6 weeks for the standard QD regimen or total 45 Gy over 3 weeks for hyperfractionated BD schedules.
3. PCI may be delivered at the discretion of investigator and local standard of care, and must be conducted after the end of cCRT and completed between 1 to 42 days to first dose of IP.
4. Have not progressed following definitive concurrent chemoradiation.
5. Life expectancy ≥ 12 weeks at Day 1. 6. ECOG 0 or 1 at enrolment.

Exclusion Criteria

1. Extensive-stage SCLC.
2. Active or prior documented autoimmune or inflammatory disorders.
3. Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.
4. Active infection including tuberculosis, HIV, hepatitis B and C.
5. Patients who received sequential chemotherapy and radiotherapy (no overlap of RT with chemotherapy).

The Estimated Number of Participants

  • Taiwan

    25 participants

  • Global

    750 participants

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