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A Phase II Study of Erlotinib and Chemotherapy for Patients With Stage IB-IIIA NSCLC With EGFR Mutations (ECON)

Phase 2
18 Years
Not Enrolling
Non Small Cell Lung Cancer, Lung Cancer

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Trial Information

A Phase II Study of Erlotinib and Chemotherapy for Patients With Stage IB-IIIA NSCLC With EGFR Mutations (ECON)

Chemotherapy and surgery in combination represents the standard of care for patients with
resectable stage IB-IIIA NSCLC. However, the 5-year survival continues to be disappointing
despite this standard of care. This study incorporates targeted therapy with an epidermal
growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) as part of a multimodality
strategy for stage IB-IIIA resectable NSCLC tumors with a known EGFR activating mutation.
The rationale for including only patients with EGFR mutations is based on recent data that
reported that patients with advanced NSCLC whose tumor harbor EGFR activating mutations had
an objective response rate of 71% with gefitinib compared with a 1% objective response rate
in patients with EGFR wild-type tumors.

Inclusion Criteria:

- Pathologic confirmation of NSCLC

- Patients must have previously untreated stage IB-IIIA NSCLC (T1-3N0-2M0)

- Patients must have lung cancer with a documented EGFR activating mutation (exon 19
deletion, L858R, L861Q)

- Patients must be candidates for resection with curative intent

- Measurable disease, defined as at least one lesion that can be accurately measured in
at least one dimension (longest diameter to be recorded on CT)

- Age greater or equal to 18 years

- Karnofsky performance status greater or equal to 70%

- Normal marrow function: leukocytes greater than or equal to 3,000/μl, absolute
neutrophil count greater than or equal to 1,500/μl, platelets greater than or equal
to 100,000/μl, hemoglobin greater than or equal to 9 gm/dl

- Adequate renal function, with creatinine less than or equal to 1.3 mg/dl or
calculated creatinine clearance greater to or equal to 60ml/min by Cockroft and Gault
equation using parameters of age, weight (kg), and baseline serum creatinine (mg/dl)

- Adequate hepatic function: Total bilirubin within normal limits, AST < 1.5 X UNL,
alkaline phosphatase < 1.5 X UNL

- Women of childbearing age must have a negative urine or blood pregnancy test

- Men and women of childbearing potential must be willing to consent to using effective
contraception while on treatment and for at least 3 months thereafter

- Patients must have ability to understand and the willingness to sign a written
informed consent document

Exclusion Criteria:

- Prior chemotherapy or radiation therapy, with the exception of chemotherapy for
nononcologic conditions (ie, methotrexate for the treatment of rheumatoid arthritis)

- Prior treatment with gefitinib, erlotinib, or other drugs that target EGFR

- Patients must not be receiving any other investigational agents

- Any evidence of interstitial lung disease (patients with chronic stable radiographic
changes who are asymptomatic need not be excluded)

- Patients who report a hearing deficit at baseline, even if it does not require a
hearing aid or intervention, or interfere with activities of daily life (CTCAE grade
2 or higher)

- Peripheral neuropathy > grade 1

- Known HIV-positive patients receiving combination anti-retroviral therapy are
excluded from the study because of possible pharmacokinetic interactions with the
study drugs.

- Other serious illness or medical condition including unstable cardiac disease
requiring treatment, history of significant neurologic or psychiatric disorders
(including psychotic disorders, dementia, or seizures), or active uncontrolled

- Women who are pregnant or breast-feeding

- Psychiatric illness or social situation that would limit compliance with study

Type of Study:


Study Design:

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

Outcome Measure:

To determine the pathologic complete response rate for patients with stage IB-IIIA NSCLC with tumors that harbor an EGFR mutation treated with neoadjuvant chemotherapy + erlotinib

Outcome Time Frame:

Patients will undergo a CT scan of chest every 3 months for year 1 and every 4 months for year 2. In years 3 and 4, a chest CT or chest x-ray every 6 months.

Safety Issue:


Principal Investigator

Naiyer Rizvi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

November 2007

Completion Date:

December 2011

Related Keywords:

  • Non Small Cell Lung Cancer
  • Lung Cancer
  • Lung Cancer
  • Erlotinib
  • clinical stage IB-IIIA
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021