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Clinical Trials List

Protocol NumberD933IC00001
NCT Number(ClinicalTrials.gov Identfier)NCT03819465
Completed

2018-12-01 - 2026-03-31

Phase I

Recruiting8

ICD-10C34.80

Malignant neoplasm of overlapping sites of unspecified bronchus and lung

ICD-10C34.81

Malignant neoplasm of overlapping sites of right bronchus and lung

ICD-10C34.82

Malignant neoplasm of overlapping sites of left bronchus and lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.8

Malignant neoplasm of other parts of bronchus or lung

A Phase IB, Open-Label, Multi-Center Study to Determine the Efficacy and Safety of Durvalumab and/or Novel Oncology Therapies, With or Without Chemotherapy, for First-Line Stage IV Non-Small Cell Lung Cancer (NSCLC) (MAGELLAN)

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator TSUNG -YING YANG Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 吳銘芳 Division of General Internal Medicine
Chung Shan Medical University Hospital

Co-Principal Investigator

  • 曹世明 Division of General Internal Medicine
  • 吳子卿 Division of General Internal Medicine
  • 王耀東 Division of General Internal Medicine

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yung-Hung Luo Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

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

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

0 Recruiting

Principal Investigator Jen-Yu Hung Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator James Chih-Hsin Yang Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chien-Chung Lin
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Metastatic Non-Small Cell Lung Cancer (NSCLC)

Objectives

A phase 1B, open-label, multicenter trial is evaluating the efficacy and safety of duvalumab in combination with novel oncology therapies (with or without chemotherapy) as first-line treatment for stage IV non-small cell lung cancer (NSCLC).

Test Drug

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Active Ingredient

Durvalumab
Danvatirsen
Oleclumab
MEDI5752
AZD2936

Dosage Form

220
270
270
270
270

Dosage

MG

Endpoints

Key endpoints: Assess the safety and tolerability of the following treatment combinations: durvalumab monotherapy, durvalumab combined with a novel oncology therapy, durvalumab combined with chemotherapy, and durvalumab combined with both a novel oncology therapy and chemotherapy.

(These treatment combinations are hereinafter collectively referred to as "durvalumab ± novel oncology therapy ± chemotherapy")

Secondary endpoints
Key secondary endpoints – Efficacy of durvalumab ± novel oncology therapy ± chemotherapy based on ORR
Efficacy of durvalumab ± novel oncology therapy ± chemotherapy based on DoR, PFS, and OS
Pharmacokinetics (PK) of durvalumab and other novel oncology therapies in all treatment groups
Immunogenicity of durvalumab and other novel oncology therapies in all applicable treatment groups

Exploratory objectives
Blood and tissue samples will be collected to investigate biomarkers that may be clinically relevant after patients receive durvalumab ± novel oncology therapy ± chemotherapy
Further evaluation of the efficacy of durvalumab + novel oncology therapy ± chemotherapy and durvalumab ± chemotherapy based on changes in tumor size

Inclution Criteria

Inclusion Criteria:

Histologically or cytologically documented Stage IV NSCLC not amenable to curative surgery or radiation
No prior chemotherapy or any other systemic therapy for metastatic NSCLC
Prior platinum-containing adjuvant, neoadjuvant, or definitive chemoradiation for advanced disease are eligible, if progression has occurred >12 months from end of last therapy
Known tumor PD-L1 status
Tumors that lack activating EGFR mutations and ALK fusions or documented local test result for any other known genomic alteration for which a targeted therapy is approved in first line per local standard of care
WHO/ECOG status at 0 or 1 at enrollment
Life expectancy of at least 12 weeks
Troponin I or T ≤ ULN (per institutional guidelines)

Exclusion Criteria

Exclusion Criteria:

Active or prior documented autoimmune or inflammatory disorders
History of active primary immunodeficiency
Any prior chemotherapy or any other systemic therapy for metastatic NSCLC
Untreated CNS metastases

The Estimated Number of Participants

  • Taiwan

    50 participants

  • Global

    200 participants

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