Erlotinib Hydrochloride Before Surgery in Treating Patients With Stage III Non-Small Cell Lung Cancer



Status:Terminated
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:November 2013
End Date:August 31, 2017

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EValuation of Erlotinib as a Neoadjuvant Therapy in Stage III NSCLC Patients With EGFR Mutations (EVENT Trial)

This phase II trial studies how well erlotinib hydrochloride works before surgery in treating
patients with stage III non-small cell lung cancer. Erlotinib hydrochloride may stop the
growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving
erlotinib hydrochloride before surgery may make the tumor smaller and reduce the amount of
normal tissue that needs to be removed.

PRIMARY OBJECTIVES:

I. To estimate the rate of mediastinal nodal clearance and complete pathological response
after neoadjuvant erlotinib (erlotinib hydrochloride) in patients with epidermal growth
factor receptor (EGFR) mutated stage III non-small cell lung cancer (NSCLC).

SECONDARY OBJECTIVES:

I. To determine the progression free survival in patient population of EGFR mutated stage III
NSCLC patients who are treated with neoadjuvant erlotinib therapy.

II. To determine the overall survival. III. To estimate the overall response rate from
neoadjuvant erlotinib. IV. To estimate the surgical resection rate. V. To evaluate the safety
of neoadjuvant erlotinib.

TERTIARY OBJECTIVES:

I. To determine several molecular and cellular biomarkers in the tumors, the skin and the
serum that are predictive of the efficacy of neoadjuvant erlotinib.

OUTLINE:

Patients receive erlotinib hydrochloride orally (PO) once daily (QD) for 2 months and then
undergo thoracotomy.

After completion of study treatment, patients are followed up at 30 days, every 3 months for
1 year, and then every 6 months for 5 years.

Inclusion Criteria:

- Pathologically proven (either histologic or cytologic) diagnosis of stage IIIA or IIIB
non-small cell lung cancer; (according to American Joint Committee on Cancer [AJCC]
staging, 7th edition) within 4 weeks of registration; the patient should have
histologically or cytologically confirmed N2 disease

- Activating mutation in EGFR

- No prior chemotherapy or radiation for lung cancer

- Patients may be potentially resectable or unresectable

- Stage III A or B disease, including no distant metastases- based on following
diagnostic workup:

- History/physical examination prior to registration

- Computed tomography (CT) scan of the chest or positron emission tomography (PET)
scan within 28 days of study entry

- CT scan of abdomen or magnetic resonance imaging (MRI) of abdomen or PET scan
within 28 days of study entry

- An MRI of the brain or head CT scan with contrast within 28 days of study entry

- Total body PET scan within 28 days of study entry

- Mediastinoscopies are highly recommended

- Patients must have measurable or evaluable disease

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- Absolute neutrophil count (ANC) >= 1,500 cells/ul

- Platelets >= 100,000 cells/ul

- Hemoglobin >= 9.0 g/dl (note: the use of transfusion or other intervention to achieve
hemoglobin [Hgb] >= g/dl is acceptable)

- Serum creatinine =< 1.5 x upper limit of normal (ULN)

- Total bilirubin < 2.0 times the institutional upper limit of normal (ULN)

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x the ULN

- Women of childbearing potential must have:

- A negative serum or urine pregnancy test (sensitivity =< 25 IU human chorionic
gonadotropin [HCG]/L) within 72 hours prior to the start of study drug
administration

- Persons of reproductive potential must agree to use and utilize an adequate
method of contraception throughout treatment and for at least 4 weeks after study
drug is stopped prior to study enrollment, women of childbearing potential must
be advised of the importance of avoiding pregnancy during trial participation and
the potential risk factors for an unintentional pregnancy

- Ability to take oral medication

- Patient must sign study specific informed consent prior to study entry

Exclusion Criteria:

- Pleural or pericardial effusion

- Pleural effusions allowed if one of the following conditions are met: 1) negative
cytology after adequate sampling by thoracentesis 2) effusion seen on CT scan but
not on chest x-ray and deemed too small to tap under CT or ultrasound guidance

- Severe, active co-morbidity, defined as follows:

- Cardiac symptoms; any of the following should be considered for exclusion:

- Uncontrolled angina, congestive heart failure or myocardial infarction (MI)
within (6 months)

- Diagnosed congenital long QT syndrome

- Any history of clinically significant ventricular arrhythmias (such as
ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)

- Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (> 450
msec)

- History of significant bleeding disorder unrelated to cancer, including:

- Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)

- Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor
VIII antibodies)

- Ongoing or recent (=< 3 months) significant gastrointestinal bleeding

- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for
treatment of either a psychiatric or physical (e.g., infectious) illness

- Men and women who:

- Are unwilling or unable to use an acceptable method to avoid pregnancy for the
entire study period and for at least 4 weeks after cessation of study drug, or
women who:

- Have a positive pregnancy test at baseline, or

- Are pregnant or breastfeeding
We found this trial at
3
sites
1300 Morris Park Ave
Bronx, New York 10461
(718) 430-2000
Principal Investigator: Haiying Cheng
Phone: 718-405-8404
Albert Einstein College of Medicine The Albert Einstein College of Medicine of Yeshiva University is...
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Bronx, NY
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, NY
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New York, New York 10021
Phone: 646-962-2066
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New York, NY
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