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Clinical Trials List

Protocol Number1200.125

2012-03-02 - 2014-08-31

Phase III

Terminated8

LUX-Lung 8: A randomized, open-label Phase III trial of afatinib versus erlotinib in patients with advanced squamous cell carcinoma of the lung as second-line therapy following first-line platinum-based chemotherapy

  • Trial Applicant

    Boehringer Ingelheim

  • Sponsor

    Boehringer Ingelheim

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator James Chih-Hsin Yang Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

  • 林育麟 Division of General Internal Medicine

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 蔡俊明 Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Cheng-Ta Yang Division of Thoracic Medicine
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Gee-chen Chang Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

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 Terminated

Principal Investigator 邱倫瑋 Division of Hematology & Oncology
Koo Foundation Sun Yat-Sen Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 賴俊良 Division of Thoracic Medicine
Hualien Tzu Chi Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Te-Chun Hsia Division of Thoracic Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Lung cancer

Objectives

Primary: Compare efficacy of afatinib with erlotinib as second-line treatment for patients with squamous cell carcinoma of the lung, as measured by progression-free survival (PFS). Key secondary: Compare overall survival (OS) in both treatment groups Secondary: Objective response rate (ORR), disease control rate (DCR), tumour shrinkage and the assessment of Health-related Quality of Life (HRQoL) and safety in both treatment groups

Test Drug

BIBW 2992 (Afatinib)

Active Ingredient

Afatinib

Dosage Form

film-coated Tablets

Dosage

20, 30, 40, 50

Endpoints

Key Secondary endpoint:
• Overall surviva

Secondary endpoints :
• Objective response (CR, PR) according to RECIST 1.1
• Disease control (CR, PR, SD) according to RECIST 1.1
• Tumour shrinkage
• Health-related Quality of Life (HRQoL)

Inclution Criteria

1. Diagnosis of advanced stage NSCLC considered to be squamous histology, including mixed histology, in the opinion of the investigator.
2. Completion of at least 4 cycles of platinum-based doublet chemotherapy, with or without additional [non-EGFR] targeted agents, as 1st line treatment of Stage IIIB/IV NSCLC.
3. Eligible to receive 2nd line therapy in the opinion of the investigator. Patients who received non-EGFR based therapy for maintenance are eligible.
4. Ability to take oral medication in the opinion of the investigator.

Exclusion Criteria

1. Prior treatment with EGFR directed small molecules or antibodies.
2. Any other current malignancy or malignancy diagnosed within the past three (3) years.
3. Known pre-existing interstitial lung disease.
4. Female patients of childbearing potential (see Section 4.2.2.3) who are nursing or are pregnant.

The Estimated Number of Participants

  • Taiwan

    50 participants

  • Global

    800 participants

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