Non-Small Cell Lung Cancer
Conditions
Keywords
Tumor vascular disrupting agent, VDA, ASA404, non-small cell lung cancer, NSCLC
Brief summary
The purpose of this study is to determine if adding ASA404 to standard chemotherapy makes the cancer treatment more effective in patients with advanced lung cancer.
Interventions
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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.) 2. Newly diagnosed Stage IIIb disease (malignant pleural effusion or pericardial effusion that have been confirmed cytologically) or Stage IV disease 3. No prior systemic antineoplastic treatment for Stage IIIb/IV non-small cell carcinoma of the lung (Prior neoadjuvant or adjuvant chemotherapy for earlier stage I/II NSCLC is allowed if 12 months or more prior to Baseline visit.) 4. Age ≥ 18 years old 5. WHO Performance Status of 0-1 6. Measurable or non-measurable disease per RECIST criteria (Post-text supplement 1) 7. Lab values within the range, as defined below, within 2 weeks of randomization: * Absolute neutrophils count (ANC) \> 2.0 x 109/L * Platelets ≥ 100 x109/L * Hemoglobin ≥ 10 g/dL * Serum creatinine ≤ 1.5 x ULN (≤ 120 micro mol/L) * Serum bilirubin ≤ 1.5 x ULN (≤ 25 micro mol/L) * Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases) * International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 x IULN (Sections 6.9.1 and 7.3.4.2) * Electrolyte values (potassium, calcium, magnesium) within \> 1 x LLN and \< 1 x ULN. Patients with corrected electrolyte values are eligible. See Sections 6.8.1 and 7.3.4.3. * Females of child-bearing potential must have negative serum pregnancy test (confirmation of negative urine pregnancy test within 72 hours prior to initial dosing). 8. Life expectancy ≥ 12 weeks 9. Written informed consent obtained according to local guidelines
Exclusion criteria
1. Patients having CNS metastases (Patients having any clinical signs of CNS metastases must have a CT or MRI of the brain performed to rule out CNS metastases in order to be eligible for study participation. Patients who have had brain metastases surgically removed or irradiated with no residual disease confirmed by imaging are allowed.). 2. Patients with a history of another primary malignancy ≤ 5 years, with the exception of non-melanoma skin cancer or cervical cancer in situ. 3. Radiotherapy ≤ 2 weeks prior to randomization. Patients must have recovered from all radiotherapy-related toxicities. 4. Major surgery ≤ 4 weeks prior to randomization or minor surgery ≤ 2 weeks prior to randomization.(Major surgery is defined by the use of general anesthesia however, endoscopic examinations with diagnostic intent are not considered major surgery. Insertion of a vascular access device is exempt from this
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival rate | Patients will be followed every six weeks for survival following treatment completion, discontinuation, or documented disease progression until either death or the data cut off date. |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival of patients with squamous and non-squamous NSCLC | Patients will be followed every six weeks for survival following treatment completion, discontinuation, or documented disease progression until either death or the data cut off date. |
Countries
Argentina, Australia, Belgium, Brazil, Canada, China, Czechia, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Netherlands, New Zealand, Poland, Singapore, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom, United States
Outcome results
None listed