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Randomized Double-Blind Placebo Controlled Phase II Trial Evaluating Erlotinib in Non-Smoking Patients With (Bevacizumab-Eligible and Ineligible) Advanced Non-Small Cell Lung Cancer (NSCLC)

Phase 2
18 Years
Not Enrolling
Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

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Trial Information

Randomized Double-Blind Placebo Controlled Phase II Trial Evaluating Erlotinib in Non-Smoking Patients With (Bevacizumab-Eligible and Ineligible) Advanced Non-Small Cell Lung Cancer (NSCLC)


I. To evaluate the progression-free survival (PFS) of non-smokers with advanced non-small
cell lung cancer randomized to receive treatment with standard care (carboplatin and
paclitaxel with or without bevacizumab) or standard care in combination with erlotinib


I. To evaluate the overall survival of these patients. II. To evaluate the response rate in
these patients. III. To evaluate the relative toxicity of these regimens in these patients.
IV. To determine the frequency of EGFR and Kras mutations in these patients and correlate
mutation status with response rate and PFS.

V. To obtain blood and tissue specimens for further marker-based exploratory analyses
regarding EGFR inhibitors.

VI. To evaluate EGFR positivity by FISH as a predictor of improved PFS in patients treated
with erlotinib hydrochloride.

OUTLINE: This is a multicenter study. Patients are stratified according to gender and
eligibility for bevacizumab therapy (ineligible vs eligible and willing to receive
bevacizumab vs eligible and not willing to receive bevacizumab). Patients are randomized to
1 of 2 treatment arms.

ARM I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes (with
or without bevacizumab IV over 30-90 minutes) on day 1. Patients also receive an oral
placebo once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the
absence of disease progression or unacceptable toxicity. After completion of 6 courses,
patients with stable or responding disease may continue to receive placebo (with or without
bevacizumab) as above in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive paclitaxel and carboplatin (with or without bevacizumab) as in arm
I. Patients also receive oral erlotinib hydrochloride once daily on days 1-21. Treatment
repeats every 21 days for 6 courses in the absence of disease progression or unacceptable
toxicity. After completion of 6 courses, patients with stable or responding disease may
continue to receive erlotinib hydrochloride (with or without bevacizumab) as above in the
absence of disease progression or unacceptable toxicity.

Blood and tissue samples are collected for correlative laboratory studies.

After completion of study treatment, patients are followed up periodically for 5 years.

Inclusion Criteria:

- Histologically or cytologically confirmed non-small cell lung cancer, meeting one of
the following criteria:

- Stage IIIB disease with pleural or pericardial effusion or multifocal pleural

- Stage IV disease

- Recurrent disease after prior curative resection or definitive radiotherapy

- Non-squamous cell histology (for patients planning to receive bevacizumab)

- Has smoked ≤ 100 cigarettes in a lifetime

- Measurable disease as defined by RECIST criteria

- No history of untreated brain metastases

- ECOG performance status 0-1

- ANC ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Bilirubin ≤ 1.5 mg/dL

- SGOT and SGPT ≤ 3 times upper limit of normal

- Creatinine ≤ 2.0 mg/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No clinically significant ongoing or active infection, symptomatic congestive heart
failure, unstable angina pectoris, symptomatic or uncontrolled cardiac arrhythmia, or
psychiatric illness/social situation that would limit compliance with study

- No other active, invasive malignancies requiring therapy

- Patients planning to receive bevacizumab must meet the following additional criteria:

- INR ≤ 3 within the past 4 weeks

- Urine protein ≤ 1+ by urine dipstick within the past 4 weeks OR urine
protein:creatinine ratio < 1.0

- No antecedent hemoptysis

- No history of thrombotic or hemorrhagic disorders

- History of hypertension allowed provided it is well controlled (i.e., BP ≤
150/90 mm Hg) and patient has been on a stable regimen of antihypertensive
therapy within the past 4 weeks

- History of myocardial infarction or other evidence of arterial thrombotic
disease (angina) allowed provided there is no evidence of active disease for ≥ 6

- No serious non-healing wound, ulcer, or bone fracture within the past 4 weeks

- No abdominal fistula, gastrointestinal perforation,or intra-abdominal abscess
within the past 6 months

- No significant vascular disease (e.g., aortic aneurysm,requires surgical repair,
or recent peripheral arterial thrombosis) within the past 6 months

- No clinically significant cardiovascular disease, including any of the

- Cerebrovascular accident within the past 6 months

- New York Heart Association class II-IV heart failure

- Serious and inadequately controlled cardiac arrhythmia

- Clinically significant peripheral vascular disease (symptomatic with
intermittent claudications or < 6 months since bypass surgery)

- No prior chemotherapy for lung cancer

- More than 3 years since prior chemotherapy for an unrelated condition

- At least 2 weeks since prior radiotherapy and recovered (alopecia and grade 1
neuropathy allowed)

- No prior irradiation to the only site of measurable disease, unless that site has had
subsequent evidence of pathology or radiologic progression

- More than 28 days since prior major surgical procedure (for patients planning to
receive bevacizumab)

- Concurrent stable doses of therapeutic anticoagulation or prophylactic
anticoagulation for venous access devices allowed (for patients planning to receive

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS)

Outcome Time Frame:

From randomization to progression of disease or death, whichever occurs first, up to 5 years

Safety Issue:


Principal Investigator

Corey Langer

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Cooperative Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

January 2010

Completion Date:

Related Keywords:

  • Recurrent Non-Small Cell Lung Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IV Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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