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A Feasibility Study Investigating Translational Science in Chemotherapy-Naive Patients With Stage IIIb or IV Non-Small Cell Lung Cancer (NSCLC) Treated With the EGFR-TKI, Erlotinib

Phase 2
18 Years
Open (Enrolling)
Lung Cancer

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Trial Information

A Feasibility Study Investigating Translational Science in Chemotherapy-Naive Patients With Stage IIIb or IV Non-Small Cell Lung Cancer (NSCLC) Treated With the EGFR-TKI, Erlotinib



- To define a pre-treatment tumor proteomic profile that predicts response, stable
disease, or progressive disease in patients with stage IIIB, stage IV, or recurrent
non-small cell lung cancer treated with erlotinib hydrochloride.


- To test and refine a pre-treatment serum proteomic expression pattern that predicts
response to erlotinib hydrochloride and/or carboplatin and paclitaxel after failing
treatment with erlotinib hydrochloride.

- To test and refine tumor proteomic profiles that predict response to carboplatin and
paclitaxel after failing treatment with erlotinib hydrochloride.

- To analyze individual and pattern(s) of erlotinib hydrochloride-induced genomic and
proteomic biomarker changes in relation to response or non-response to treatment.

- To correlate the efficacy and toxicity of erlotinib hydrochloride with expression of
EGFR, EGFR pathway, ErbB family, and other related biomarkers.

- To determine a set of biomarkers to be evaluated in tumor tissue or surrogate tissues
prior to treatment with erlotinib hydrochloride to enable patient selection for

- To estimate response rate and progression-free and overall survival of patients treated
with erlotinib hydrochloride as initial therapy.

- To characterize the safety profile of erlotinib hydrochloride in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral erlotinib hydrochloride once daily until disease progression.

At the time of disease progression, patients receive standard chemotherapy comprising
paclitaxel IV over 3 hours and carboplatin IV over 15-30 minutes on day 1. Patients with
non-squamous cell non-small cell lung cancer also receive bevacizumab IV over 30-90 minutes
on day 1. Treatment repeats every 21 days for up to 6 courses.

Tumor tissue, plasma, serum, and urine samples are collected at baseline for proteomics

After the completion of study treatment, patients are followed every 8 weeks.

Inclusion Criteria


- Histologically confirmed non-small cell lung cancer (NSCLC), meeting 1 of the
following criteria:

- Stage IIIB (with pleural effusion) or stage IV disease

- Recurrent disease after prior surgery

- Measurable or evaluable disease is desirable but not required

- No untreated symptomatic brain metastases

- Patients who are neurologically unstable despite radiotherapy for the brain
metastases are not eligible

- No requirement for steroids to control neurological symptoms


- ECOG performance status 0-2

- ANC ≥ 1,500/mm³

- Hemoglobin ≥ 9 g/dL

- Platelet count ≥ 100,000/mm³

- Creatinine ≤ 2.0 mg/dL

- Total bilirubin ≤ 1.5 mg/dL

- Normal hemostasis by history

- PT/PTT within 0.5 seconds of normal range

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Willing to undergo biopsy procedures

- No known severe hypersensitivity to erlotinib hydrochloride or any of the excipients
of this product

- No other concurrent malignancies or malignancies diagnosed within the past 5 years,
except basal cell carcinoma or cervical cancer in situ

- No significant cardiac disease, including any of the following:

- NYHA class III or IV heart disease

- Uncontrolled dysrhythmia

- Myocardial infarction within the past 6 months

- No evidence of clinically active interstitial lung disease

- Chronic stable radiographic changes that are asymptomatic allowed

- No evidence of any other severe or uncontrolled systemic disease (e.g., unstable or
uncompensated respiratory, cardiac, hepatic, or renal disease)

- No evidence of any other significant clinical disorder or laboratory finding that
makes it undesirable for the patient to participate in the trial

- No uncontrolled hypertension

- Blood pressure must be ≤ 150/90 mmHg on a stable antihypertensive regimen


- See Disease Characteristics

- At least 6 months since prior adjuvant chemotherapy

- No unresolved chronic toxicity > CTC grade 2 from prior anticancer therapy (except

- More than 30 days since prior non-approved or investigational drugs

- No prior chemotherapy for advanced NSCLC

- No concurrent phenytoin, carbamazepine, rifampin, barbiturates, or St. John's wort

- No concurrent administration of other drugs known to inhibit EGFR

- No other concurrent anti-neoplastic or anti-tumor agents, including chemotherapy,
radiotherapy, immunotherapy, or hormonal anticancer therapy

- No other concurrent investigational agents

- Concurrent cardioprotective doses of aspirin, as recommended by the physician, for
cardiovascular disease allowed

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pre-treatment tumor proteomic profile as a predictor of response, stable disease, or progressive disease

Outcome Time Frame:

End of treatment date

Safety Issue:


Principal Investigator

David Carbone, M.D., Ph.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center


United States: Vanderbilt University

Study ID:




Start Date:

October 2007

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • recurrent non-small cell lung cancer
  • squamous cell lung cancer
  • adenosquamous cell lung cancer
  • bronchoalveolar cell lung cancer
  • large cell lung cancer
  • adenocarcinoma of the lung
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
University of Florida Shands Cancer Center Gainesville, Florida  32610-0232
M. D. Anderson Cancer Center at University of Texas Houston, Texas  77030-4009
Emory University Atlanta, Georgia  30322
Vanderbilt-Ingram Cancer Center - Cool Springs Nashville, Tennessee  37064
Vanderbilt-Ingram Cancer Center at Franklin Nashville, Tennessee  37064