ATTRACT-2 Overview

ATTRACT-2 Study Title:

ATTRACT-2 Study Design:

ATTRACT-2 Primary Endpoint:

• Comparative overall survival of non-small cell lung cancer patients receiving ASA404 or placebo in combination with docetaxel for second-line treatment of stage IIIb/IV NSCLC.

ATTRACT-2 Key Secondary Endpoints:

• Comparative progression-free survival and overall response rate of patients receiving ASA404 or placebo in combination with docetaxel.

For more information, please visit www.attractstudy.com or call the Novartis Oncology Clinical Trials Hotline at 1-800-340-6843.^* * For countries outside the United States, please contact your local Novartis representative for more information.

ATTRACT-2 Key Inclusion Criteria:

• Histologically confirmed non–small cell carcinoma of the lung (Histological or cytological specimens must be collected via surgical biopsy, brushing, washing or core needle aspiration of a defined lesion. Sputum cytology is not acceptable).
• Progression while on or following a first-line chemotherapy regimen for stage IIIb disease (malignant pleural effusion or pericardial effusion that has been confirmed cytologically) or stage IV disease. Patients who have received bevacizumab and/or EGFR inhibitors in first line cancer treatment will be eligible.
• Age ≥18 years.
• WHO Performance Status of 0 to 2.
• Measurable or nonmeasurable disease per RECIST (Response Evaluation Criteria in Solid Tumors) criteria.
• Life expectancy ≥12 weeks.

ATTRACT-2 Key Exclusion Criteria:

• CNS metastases (Patients having any clinical signs of CNS metastases must have a CT scan or MRI of the brain performed to rule out CNS metastases in order to be eligible for ATTRACT-2 study participation. Patients who have had brain metastases surgically removed or irradiated with no residual disease confirmed by imaging are allowed).
• History of another primary malignancy ≤ 5 years, with the exception of nonmelanoma skin cancer or cervical cancer in situ.
• Radiotherapy ≤2 weeks prior to randomization. Patients must have recovered from all radiotherapy-related toxicities.
• Major surgery ≤4 weeks prior to randomization (major surgery is defined by the use of general anesthesia). Endoscopic examinations with diagnostic intent are not considered major surgery. Minor surgery ≤2 weeks prior to randomization. Insertion of a vascular access device is allowed. Patients must have recovered from all surgery-related complications.
• Treatment with first-line chemotherapy ≤3 weeks prior to randomization (≤6 weeks for bevacizumab, mitomycin, and nitrosoureas).
• Concurrent use of other investigational agents or use of investigational agents ≤4 weeks prior to randomization.
• Prior cancer treatment with docetaxel, VDAs or Tumor-VDAs for NSCLC in the first-line setting.
• Pleural effusion that causes ≥ CTC grade 2 dyspnea.
• Systolic BP >160 mm Hg and/or diastolic BP >90 mm Hg while on medication for hypertension.
• Recent hemoptysis associated with NSCLC (>1 teaspoon in a single episode within 4 weeks).
• Any 1 of the following:

  Long QT syndrome.

  Baseline 12-lead ECG QTc of >450 msec per central evaluation.

  Congestive heart failure (NY Heart Association class III or IV).

  Myocardial infarction within 12 months of study entry or with implanted cardiac pacemaker.

  Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris.

  History of labile hypertension or poor compliance with antihypertensive regimen.

  History of a sustained ventricular tachycardia.

  Any history of ventricular fibrillation or Torsades de Pointes.

  Right bundle branch block and left anterior hemiblock (bifasicular block).

  Bradycardia defined as heart rate <50 beats per minute.

• Concomitant use of drugs with a risk of causing Torsades de Pointes.
• Known allergy or hypersensitivity to docetaxel or drugs formulated with polysorbate 80.
• Peripheral sensory neuropathy with functional impairment (CTC grade 2 neuropathy, regardless of causality).
• Concurrent severe and/or uncontrolled medical disease (eg, uncontrolled diabetes, chronic renal disease, chronic liver disease, confirmed diagnosis of HIV infection or active uncontrolled infection).
• Significant neurologic or psychiatric disorder that could compromise participation in the study.