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Understanding Mechanisms of Acquired Resistance to BIBW2992

18 Years
Open (Enrolling)
Non-small Cell Lung Cancer, EGFR Mutations

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Trial Information

Understanding Mechanisms of Acquired Resistance to BIBW2992

- Participants will take tables of BIBW 2992 once a day during each cycle. Each cycle is
28 days (4 weeks).

- Participants will come to the clinic on Day 1, 8 and 15 of Cycle 1. For Cycle 2
through 8, they woll need to come to the clinic on Day 1. After Cycle 8, they will
have study visits every 2 months.

- The following tests and procedures will be performed at these clinic visits: physical
examination, routine blood tests, research blood samples, EKG (every fourth cycle
starting cycle 5), ECHO or MUGA (every fourth cycle starting cycle 5), an assessment fo
the tumor by CT or MRI scan (every 8 weeks).

- Participants may continue to participate in this research study as long as their tumor
does not grow and their disease does not worsen and they do not have any severe side

- Participants will have a tumor biopsy performed at the end of their participation in
this study if their tumor is growing or if they have a new tumor. The purpose of this
biopsy is to assess for the presence or the absence of the mutation T790M.

Inclusion Criteria:

- Participants must have histologically or cytologically confirmed stage IIIB, IV or
recurrent non-small cell lung cancer

- A somatic mutation in epidermal growth factor receptor (EGFR) must be present as
documented by a CLIA-certified laboratory

- There must be radiographic measurable or evaluable disease

- Participants must be willing, at the time of signing consent, to agree to a future
biopsy of their tumor tissue at the time of disease progression, provided such a
biopsy is safe and feasible at that time.

- Performance status must be 0, 1 or 2 on the Eastern Cooperative Oncology Group scale

- 18 years of age or older

- Normal organ and marrow function as outlined in the protocol

- Women of child-bearing potential and men must agree to use adequate contraception
prior to study entry and for the duration of study participation

Exclusion Criteria:

- Prior EGFR tyrosine kinase inhibitor therapy (including gefitinib, erlotinib, or any
experimental EGFR TKI agents)

- Known brain metastases, unless they have undergone definitive therapy and are
neurologically stable at the time of study entry

- Standard chemotherapy or radiation less than 2 weeks of starting BIBW 2992, or
experimental systemic cancer therapy less then 4 weeks of starting BIBW 2992. Note
that prior palliative radiation to bony disease, CNS disease, or a limited thoracic
area is allowed if there is measurable or progressive disease outside the field of

- Another malignancy within the last 3 years (except for non-melanoma skin cancer or a
non-invasive/in situ cancer)

- Known pre-existing and clinically active interstitial lung disease

- Significant gastrointestinal disorders with diarrhea as a major symptom

- History of clinically relevant cardiovascular abnormalities such as uncontrolled
hypertension, congestive heart failure NYHA classification of 3, unstable angina or
poorly controlled arrhythmia, or myocardial infarction within 6 months

- Cardiac left ventricular function with resting ejection fraction <50%

- Any other concomitant serious illness or organ system dysfunction which in the
opinion of the investigator would either compromise patient safety or interfere with
the evaluation of the safety of the study drug

- Pregnancy or breast feeding

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition of BIBW 2992

- Life expectancy of < 12 weeks

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the proportion of patients that have a T790M mutation on their progression biopsy and to compare this with published data for first-generation EGFR tyrosine kinase inhibitors.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Lecia V. Sequist, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

February 2011

Completion Date:

December 2014

Related Keywords:

  • Non-Small Cell Lung Cancer
  • EGFR Mutations
  • BIBW 2992
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Massachusetts General HospitalBoston, Massachusetts  02114-2617