A Phase II Trial of Afatinib(BIBW 2992) in Third-line Treatment for Patients With Stage IIIB/IV Adenocarcinoma of the Lung Harbouring Wild-type Epidermal Growth Factor Receptor[EGFR]

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01003899
First received: October 28, 2009
Last updated: December 5, 2013
Last verified: August 2013
  Purpose

To explore the efficacy of BIBW 2992 defined by the objective response rate (Complete Response, Partial Response) as determined by Response Evaluation Criteria in Solid Tumours[RECIST] 1.1 in the patients with advanced (stage IIIB or IV) adenocarcinoma of the lung harbouring wild-type EGFR.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: afatinib (BIBW 2992)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of BIBW 2992 as a Third-line Treatment for Patients With Stage IIIB/IV Adenocarcinoma of the Lung Harbouring Wild-type EGFR

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Percentage of Participants With Best Objective Response [ Time Frame: Baseline till progression or death ] [ Designated as safety issue: No ]
    Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST (version 1.1).


Secondary Outcome Measures:
  • Percentage of Participants With Disease Control (DC) [ Time Frame: Baseline till progression or death ] [ Designated as safety issue: No ]
    Percentage of participants with objective response or stable disease (SD) as determined by RECIST version 1.1.

  • Progression Free Survival (PFS) Time [ Time Frame: Baseline till end of study or death ] [ Designated as safety issue: No ]
    PFS time is defined as time from start of treatment to the earliest of progression (RECIST version 1.1), clinical progression (investigator), start of new anti-cancer treatment or death

  • Duration of Disease Control (DC) [ Time Frame: Baseline till progression or death ] [ Designated as safety issue: No ]
    Duration of diesease control (DC) (objective response or stable disease (SD) as determined by RECIST version 1.1).

  • Time to OR [ Time Frame: Baseline till progression or death ] [ Designated as safety issue: No ]
    The time to objective response (OR) was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST 1.1 criteria.

  • Duration of OR [ Time Frame: Baseline till progression or death ] [ Designated as safety issue: No ]
    Duration of OR was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death was objectively documented.


Enrollment: 43
Study Start Date: October 2009
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: afatinib (BIBW 2992)
patient to receive afatinib(BIBW 2992) po QD in an open-label manner
Drug: afatinib (BIBW 2992)
afatinib (BIBW 2992) po QD

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Pathologically confirmed stage IIIB/IV adenocarcinoma in non-small cell lung cancer[NSCLC]
  2. Progressive disease following a second-line cytotoxic chemotherapy including at least one platinum-containing regimen
  3. A known wild-type EGFR status
  4. Patients 18 years of age or older

Exclusion criteria:

  1. More than two prior cytotoxic chemotherapy treatment regimens for relapsed or metastatic disease
  2. Prior treatment with EGFR targeting small molecules or antibodies
  3. Radiotherapy or surgery within 4 weeks prior to study entry
  4. Active brain metastasis
  5. Known pre-existing interstitial lung disease
  6. History or presence of clinically relevant cardiovascular abnormalities
  7. Cardiac left ventricular function with resting ejection fraction of less than 50%
  8. Absolute neutrophil count[ANC] < 1,500/mm3
  9. Platelet count <100,000/mm3
  10. Creatinine clearance<60ml/min or serum creatinine >1.5 times upper limit of normal
  11. Women of childbearing potential, or men who are able to father a child, unwilling to use a medically acceptable method of contraception during the trial
  12. Pregnancy or breast-feeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01003899

Locations
Korea, Republic of
1200.72.8203 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1200.72.8202 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1200.72.8201 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01003899     History of Changes
Other Study ID Numbers: 1200.72
Study First Received: October 28, 2009
Results First Received: August 8, 2013
Last Updated: December 5, 2013
Health Authority: Korea, Republic of: Korea Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014