問卷
Log In
繁中 EN
TPIDB
TPIDB Outstanding PI
TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol Number1200.23
NCT Number(ClinicalTrials.gov Identfier)NCT00656136

2008-03-01 - 2010-06-30

Phase II/III

Terminated7

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

Phase IIb/III randomized, double-blind trial of BIBW 2992 plus best supportive care (BSC) versus placebo plus BSC in non-small cell lung cancer patients failing erlotinib or gefitinib.

  • Trial Applicant

    Boehringer Ingelheim

  • Sponsor

    Boehringer Ingelheim

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Han-Pin Kuo Division of Thoracic Medicine
Linkou Chang Gung Medical Foundation

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

Principal Investigator 蔡俊明 Division of Thoracic Medicine
Taipei Veterans General Hospital

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 TSU-YI CHAO Division of Hematology & Oncology
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Wu-Chou Su Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Non-small cell lung cancer

Objectives

The primary objective of this randomized trial is to determine the efficacy of BIBW 2992 as a single agent (Arm A) as compared to a matching placebo (Arm B) in this patient population. Patients on both treatment arms will receive best supportive care in addition to study treatment.

Test Drug

BIBW 2992

Active Ingredient

BIBW 2992

Dosage Form

Film-Coated Tablets

Dosage

Film-Coated Tablets50, 40, 30　

Endpoints

Primary Outcome Measures:
1.Overall Survival [ Time Frame: From randomization until death or the last patient out date, an average of 12 months ].
Secondary Outcome Measures:
1.Progression-free Survival (PFS) [ Time Frame: From randomization to disease progression, death or the data cutoff on 07 July 2010, an average of 3.3 months ].
2.Objective Response Rate (OR) [ Time Frame: From randomization to disease progression, death or the data cutoff on 07 July 2010, an average of 3.3 months ].

Inclution Criteria

1.Patients with pathologic confirmation of NSCLC Stage III-B (with pleural effusion) or Stage IV adenocarcinoma who have failed at least one but not more than two lines of cytotoxic chemotherapy (including adjuvant chemotherapy). One of the chemotherapy regimens must have been platinum-based.
2.Progressive disease following at least 12 weeks of treatment with erlotinib (Tarceva®) or gefitinib (Iressa®)
3.Eastern Cooperative Oncology Group (ECOG, R01-0787) performance Score 0, 1 or 2
4.Patients with at least one tumor lesion that can accurately be measured by magnetic resonance imaging (MRI), or computed 1.tomography (CT) in at least one dimension with longest diameter to be recorded as >20 mm using conventional techniques or >10 mm with spiral CT scan
5.Male and female patients age >18 years
6.Life expectancy of at least three (3) months
7.Written informed consent that is consistent with ICH-GCP guidelines

Exclusion Criteria

1.Use of erlotinib (Tarceva®) or gefitinib (Iressa®) within 14 days of treatment Day 1
2.Chemo-, hormone- (other than megestrol acetate or steroids required for maintenance non-cancer therapy) or immunotherapy within the past 4 weeks
3.Active brain metastases
4.Significant or recent acute gastrointestinal disorders with diarrhea
5.Patients who have any other life-threatening illness or organ system dysfunction,
6.Other malignancies diagnosed within the past five (5) years
7.Radiotherapy within the past 2 weeks prior to treatment
8.History of clinically significant or uncontrolled cardiac disease
9.Adequate ANC and platelet count
10.Adequate liver and kidney function
11.Patients with any serious active infection including known HIV, active hepatitis B or active hepatitis C

The Estimated Number of Participants

  • Taiwan

    100 participants

  • Global

    450 participants

聯絡我們

台灣臨床試驗主持人資料庫 TPIDB

All Contents Copyright 2020 台灣臨床試驗主持人資料庫TPIDB