NCT01003899

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
2 years until next milestone

Results Posted

Study results publicly available

October 17, 2013

Completed
Last Updated

December 31, 2013

Status Verified

August 1, 2013

Enrollment Period

2.1 years

First QC Date

October 28, 2009

Results QC Date

August 8, 2013

Last Update Submit

December 5, 2013

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Best Objective Response

    Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST (version 1.1).

    Baseline till progression or death

Secondary Outcomes (5)

  • Percentage of Participants With Disease Control (DC)

    Baseline till progression or death

  • Progression Free Survival (PFS) Time

    Baseline till end of study or death

  • Duration of Disease Control (DC)

    Baseline till progression or death

  • Time to OR

    Baseline till progression or death

  • Duration of OR

    Baseline till progression or death

Study Arms (1)

afatinib (BIBW 2992)

EXPERIMENTAL

patient to receive afatinib(BIBW 2992) po QD in an open-label manner

Drug: afatinib (BIBW 2992)

Interventions

afatinib (BIBW 2992)DRUG

afatinib (BIBW 2992) po QD

afatinib (BIBW 2992)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • More than two prior cytotoxic chemotherapy treatment regimens for relapsed or metastatic disease
  • Prior treatment with EGFR targeting small molecules or antibodies
  • Radiotherapy or surgery within 4 weeks prior to study entry
  • Active brain metastasis
  • Known pre-existing interstitial lung disease
  • History or presence of clinically relevant cardiovascular abnormalities
  • Cardiac left ventricular function with resting ejection fraction of less than 50%
  • Absolute neutrophil count\[ANC\] \< 1,500/mm3
  • Platelet count \<100,000/mm3
  • Creatinine clearance\<60ml/min or serum creatinine \>1.5 times upper limit of normal
  • 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
  • Pregnancy or breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

1200.72.8201 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1200.72.8202 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1200.72.8203 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

Related Publications (1)

  • Ahn MJ, Kim SW, Cho BC, Ahn JS, Lee DH, Sun JM, Massey D, Kim M, Shi Y, Park K. Phase II study of Afatinib as third-line treatment for patients in Korea with stage IIIB/IV non-small cell lung cancer harboring wild-type EGFR. Oncologist. 2014 Jul;19(7):702-3. doi: 10.1634/theoncologist.2013-0419. Epub 2014 May 27.

    PMID: 24868099DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Afatinib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AmidesOrganic ChemicalsQuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim Pharmaceuticals
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2009

First Posted

October 29, 2009

Study Start

October 1, 2009

Primary Completion

November 1, 2011

Last Updated

December 31, 2013

Results First Posted

October 17, 2013

Record last verified: 2013-08

Locations

KR(3)