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Treatment With BIBW 2992, Irreversible Inhibitor of EGFR and HER-2 in Non Small Cell Lung Cancer in Advanced Stage, Which Have Progressed to Chemotherapy. Analysis of Mutations in EGFR, KRAS and Number of Copies of HER-2

Phase 2
18 Years
Open (Enrolling)
Non-Small Cell Lung Cancer, EGFR Tyrosine Kinase Inhibitor 324674

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Trial Information

Treatment With BIBW 2992, Irreversible Inhibitor of EGFR and HER-2 in Non Small Cell Lung Cancer in Advanced Stage, Which Have Progressed to Chemotherapy. Analysis of Mutations in EGFR, KRAS and Number of Copies of HER-2

Inclusion Criteria:

- Diagnosis of lung cancer non-small cell (stage IIIB or IV) inoperable, locally
advanced, recurrent or metastatic, histologically or cytologically documented.

- The patient must present evidence of measurable disease.

- 18 years of age or older.

- ECOG performance status of 0-2

- Life expectancy at least 12 weeks.

- lung cancer patients with advanced non-small cell, stage IIIB / IV who have received
at least one cycle of systemic chemotherapy standard platinum-based first-or
second-line fault has been documented that treatment.

- are admissible 3 or more prior chemotherapy regimens. Patients must have recovered
from any toxic effects and should have passed at least 2 weeks after the last dose
prior to registration (14 days for vinorelbine and other vinca alkaloids or
gemcitabine). Patients in the opinion of the investigator are fully recovered from
surgery for 4 weeks at least, can also be considered for the study. Patients must
have recovered from any severe toxicity (CTC ≤ 1) caused by any previous therapy.

- granulocyte count ≥ 1.5x 109 / L and platelet count> 100 × 109 / L.

- serum bilirubin should be ≤ 1.5 X ULN

- AST and / or ALT ≤ 2 ULN (or ≤ 5 x ULN when clearly attributable to the presence of
liver metastases).

- Serum creatinine ≤ 1.5 (ULN) or creatinine clearance ≥ 60ml/min

- Ability to comply with study procedures and monitoring.

- Of all women of childbearing potential should be obtained a negative pregnancy test
within 72 hours before the start of therapy.

- Patients with reproductive potential must use effective contraception.

- Written informed consent (signed) to participate in the study.

Exclusion Criteria:

- Any unstable systemic disease (including active infection, grade 4 hypertension,
unstable angina, congestive heart failure, liver disease, renal or metabolic).

- Pre-treatment with systemic anti-tumor therapy with EGFR inhibitors (tyrosine kinase

- Any other malignancy within the previous 5 years (except for carcinoma in situ of the
cervix or skin cancer adequately treated basal cell type).

- Excluded patients with brain metastases or spinal cord compression of newly diagnosed
and / or have not been definitively treated with surgery and / or radiation,
supporting both patients with CNS metastases or spinal cord compression previously
diagnosed and treated with evidence of stable disease (clinically stable on imaging
studies) for a minimum of 2 months.

- Any significant ophthalmologic abnormality, especially severe syndrome of dry eye,
keratoconjunctivitis sicca, Sjogren's syndrome, severe keratitis exposure and any
other condition that may increase the risk of corneal epithelial damage. We do not
recommend the use of contact lenses during the study. The decision to continue with
the use of contact lenses should be discussed with the treating oncologist and the
patient's ophthalmologist.

- Patients unable to take oral medication, requiring intravenous nutrition, which have
undergone prior surgical procedures affecting absorption, or who have active peptic

- lactating women.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate or objective response

Outcome Description:

Is assigned to each subject the best objective response according to the investigator's decision (according to RECIST criteria). This is defined as the best response recorded from the start of treatment until progression / recurrence of disease. For patients with response status partial (PR) or complete response (CR), changes in tumor measurements must be confirmed by repeated assessments to be made not less than 4 weeks after it first reached the response criteria The CT will be made every two months to assess response to treatment. The objective response will be summarized descriptively.

Outcome Time Frame:

from the start of consumption until at least 6 months after stopping BIBW 2992 or when all patients have died.

Safety Issue:


Principal Investigator

Oscar G Arrieta, MD M Sc

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mexico. National Cancer Institute


Mexico: Ethics Committee

Study ID:




Start Date:

August 2010

Completion Date:

December 2012

Related Keywords:

  • Non-Small Cell Lung Cancer
  • EGFR Tyrosine Kinase Inhibitor 324674
  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms