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A Phase II Trial of Erlotinib and AT-101 in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients With EGFR Activating Mutations

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

A Phase II Trial of Erlotinib and AT-101 in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients With EGFR Activating Mutations

Inclusion Criteria:

- Ability to understand and the willingness to sign a written informed consent form;
the consent form must be signed by the patient prior to any study-specific

- Patients age ≥ 18 years with histologically confirmed wet Stage IIIB (with malignant
pleural effusion) or Stage IV non-small cell lung cancer (metastatic or recurrent).

- Pathologic confirmation of non-small cell lung cancer at Memorial Sloan-Kettering
Cancer Center.

- Presence of exon 19 or exon 21 EGFR activating mutation.

- No prior EGFR tyrosine kinase therapy.

- No prior systemic therapy for advanced NSCLC (Stage IIIB with malignant effusion or
Stage IV)

- Karnofsky performance status > or = to 70% OR ECOG performance status ≤ 2.

- Measurable disease defined as greater than or equal to one known/suspected malignant
lesion > or = to 1 cm measurable in two dimensions.

- Adequate hematologic, renal, and/or hepatic function: WBC > or = to 3,000/ul,
hemoglobin > or = to 9.0 g/dl, platelet count > or = to 100,000/ul, total bilirubin ≤
1.5 X UNL, AST ≤ 2.5 X UNL, and serum creatinine within 1.5 x the upper limit of
normal (<1.95 at MSKCC) or calculated creatinine clearance > or = to 60 ml/min.

- Able to swallow and retain oral medication.

- Willingness and ability to comply with study procedures and follow-up examination.

- Four weeks since any major surgery, completion of radiation, or completion of all
prior chemotherapy.

- Acute toxicities of any prior therapy must have resolved to < Grade 1 or baseline
prior to starting study therapy.

- Effective contraception.

Exclusion Criteria:

- Prior treatment with gefitinib, erlotinib, or other EGFR tyrosine kinase inhibitor

- Concurrent cytotoxic or biological therapy.

- Known KRAS mutation.

- History within the past 6 months of myocardial infarction, cardiac stent placement,
or intermittent ischemia with troponin leak.

- Active secondary malignancy or history of other malignancy within the last 3 years
except non-melanoma skin cancer and in-situ carcinoma of the cervix.

- Active, serious comorbid medical conditions including severe infection, malnutrition,
unstable angina, congestive heart failure (New York Heart Association Class III or
IV), pulmonary fibrosis, or condition that would be felt by treating physician to
preclude safe participation in the clinical trial.

- Patients with malabsorption syndrome or diseases significantly affecting the
gastrointestinal tract including prior gastric resection or small bowel resection,
inflammatory bowel disease, or partial or complete small bowel obstruction.

- Unstable brain or leptomeningeal metastases including patients who continue to
require glucocorticoids for brain or leptomeningeal metastases.

- Women who are pregnant or breast-feeding.

- Inability/unwillingness to comply with protocol treatment or follow-up.

Type of Study:


Study Design:

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

Outcome Measure:

Radiographic objective response rate (CR+PR, by WHO criteria for standard bidimensional tumor measurement) after one 21-day cycle of combination therapy with erlotinib and AT-101

Outcome Time Frame:

21 days after cycle one

Safety Issue:


Principal Investigator

Naiyer Rizvi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

September 2009

Completion Date:

May 2010

Related Keywords:

  • Lung Cancer
  • AT-101
  • erlotinib
  • Unresectable Stage IIIB
  • 09-026
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Memorial Sloan Kettering Cancer CenterNew York, New York  10021