Back to resultsASA404 or Placebo in Combination With Paclitaxel and Carboplatin as First-Line Treatment for Stage IIIb/IV Non-Small Cell Lung Cancer (ATRACT-1)
Primary Purpose
Non-Small Cell Lung Cancer
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ASA404
Placebo
carboplatin
Paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Tumor vascular disrupting agent, VDA, ASA404, non-small cell lung cancer, NSCLC
Eligibility Criteria
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.)
- Newly diagnosed Stage IIIb disease (malignant pleural effusion or pericardial effusion that have been confirmed cytologically) or Stage IV disease
- 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.)
- Age ≥ 18 years old
- WHO Performance Status of 0-1
- Measurable or non-measurable disease per RECIST criteria (Post-text supplement 1)
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).
- Life expectancy ≥ 12 weeks
- Written informed consent obtained according to local guidelines
Exclusion Criteria:
- 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.).
- Patients with a history of another primary malignancy ≤ 5 years, with the exception of non-melanoma 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 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 exclusion criteria. Patients must have recovered from all surgery-related complications.
- Concurrent use of other investigational agents and patients who have received investigational agents ≤ 4 weeks prior to randomization
- Prior exposure to Tumor-VDAs or other vascular targeting agents (anti-VEGF, anti-VEGF receptor agents, anti-EGFR agents [bevacizumab, cetuximab, etc.])
- Pleural effusion that causes ≥ CTC grade 2 dyspnea
- Patients with systolic BP > 160 mm Hg and/or diastolic BP >90 mm Hg
- Patients with recent hemoptysis associated with NSCLC (> 1 teaspoon in a single episode within 4 weeks)
Patients with any one of the following:
- Patients with long QT syndrome
- Patients with a Baseline 12-lead ECG QTc of > 450 msec per central evaluation
- Congestive heart failure (NY Heart Association class III or IV)
- Patients with a myocardial infarction within 12 months of study entry
- Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris
- History of labile hypertension or poor compliance with anti-hypertensive 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 (See Table 6-3)
- Known allergy or hypersensitivity to platinum-containing drugs, taxanes, other drugs formulated in Cremophor EL (polyoxyethylated castor oil) or any known excipients of these drugs.
- Peripheral sensory neuropathy with functional impairment (CTC grade 2 neuropathy, regardless of causality)
Pregnant or breast feeding females
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml)
Women of child bearing potential or sexually active males, unwilling or unable to use the required highly effective method(s) of contraception for both sexes while receiving treatment and for at least 6 months after the discontinuation of study treatment. (Adequate forms of contraception include IUD, oral or depot contraceptive or the barrier method plus spermicide.)
• Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions while taking paclitaxel and therefore are not considered effective contraceptive methods for this study when used as a single agent. Therefore, it is highly recommended that a concomitant barrier method be used with oral, implantable, or injectable contraceptives. The investigator shall counsel the patient accordingly. Women of childbearing potential must have a negative pregnancy test (serum or urine) 72 hours prior to administration of study treatment. For a list of substrates of human liver microsomal P450 enzymes, visit website (http://medicine.iupui.edu/flockhart/)
- Concurrent severe and/or uncontrolled medical disease (i.e. uncontrolled diabetes, chronic renal disease, chronic liver disease, confirmed diagnosis of HIV infection or active uncontrolled infection).
- Significant neurologic or psychiatric disorder which could compromise participation in the study Patient unwilling or unable to comply with the protocol
Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- University of South Alabama/Mitchell Cancer Institute
- Arizona Oncology Associates
- University of Arizona Cancer Center
- Highlands Oncology Group
- Genesis Cancer Center
- Alta Bates Summit Medical Center
- Pacific Oncology and Hematology Association
- Cancer Care Associates
- Ronald Yanagihara - Private Practice
- California Cancer Care
- Moores UCSD Cancer Center
- Loma Linda University Cancer Center
- Cedars Sinai Medical Center
- University of California Irvine Comprhensive Center
- Loma Linda Oncology Medical Group, Inc.
- UC Davis Comprehensive Cancer Center
- California Pacific Medical Research Institute
- Redwood Regional Cancer Center
- Georgetown University Hospital
- Palm Beach Institute of Hematology & Oncology
- Florida Cancer Specialists
- Cancer Centers of Central Florida, PA
- Advanced Medical Specialties (ACORN)
- Northwest Georgia Oncology Centers
- Cancer Research Center of Hawaii
- Kootenai Cancer Center (ACORN)
- Advocate Illinois Masonic Medical Center
- Illinois Oncology/Warren Billhartz Cancer Ctr.
- Loyola University Medical Center
- Hematology/Oncology of North Shore
- Loyola Cancer Care & Research Ctr. at Central Dupage Hospital
- Ft. Wayne Oncology and Hematology
- Siouxland Hematology-Oncology Assoc., LLC
- Kansas City Cancer Center, Southwest
- University of Louisville - James Graham Brown Cancer Center
- Hematology Oncology Specialists
- Louisiana State University Health Sciences Center - Feist-Weiller Cancer Center
- St. Agnes Cancer Center
- Sinai Hospital of Baltimore - The Alvin & Lois Lapidus Cancer Institute
- The Harry and Jeanette Weinberg Cancer Institute at Franklin Square/MedStar Health
- Peninsula Regional Oncology and Hematology
- Boston VA Healthcare System
- Fallon Clinic
- Breslin Cancer Center
- Osteopathic Medical Oncology and Hematology PC
- St. Luke's Hospital - St Luke's Cancer Center
- Kansas City Veterans Affair Medical Center
- St. Louis University Cancer Center
- Center for Cancer Care and Research (US Oncology)
- St. John's Mercy Medical Center
- St. Louis Cancer and Breast Institute
- Billings Clinic
- Sletten Cancer Institute
- University of Nebraska Medical Center
- Eastchester Center for Cancer Care
- Arena Oncology Associates
- New York Oncology Hematology
- Hematology Oncology Associates of Rockland
- Rochester General Hospital - Lipson Cancer Center
- Syracuse VA Medical Center
- Alamance Regional Medical Center-Cancer Ctr.
- Carolina Cancer Mgmt/Cape Fear Valley Health System/Med Onc
- Akron City Hospital
- Oncology Hematology Care Research
- University Hospitals of Cleveland
- Medical Oncology Hematology Associates, Inc. - Dayton Clinical Oncology Program
- Medical Oncology Hematology Associates, Inc.
- Cleo Craig Memorial Cancer Ctr. & Research Clinic
- University of Oklahoma Health Science Center
- Kaiser Permanente, Northwest Region
- Allegheny General Hospital/Allegheny Cancer Center
- South Carolina Oncology Associate
- Lowcountry Hematology & Oncology PA
- Chattanooga Oncology Hematology Associates
- The West Clinic
- Tennessee Oncology
- Texas Oncology Cancer Center of the High Plains
- Arlington Cancer Center
- Patient's Comprehensive Cancer Center
- South Texas Cancer Institute
- Cancer Care Centers of South Texas
- Texas Oncology at Presbyterian Hospital
- University of Texas Southwestern Medical Center/Simmons Comprehensive Cancer Center
- Texas Oncology at Garland
- HOPE Oncology
- Tyler Cancer Center
- UT Health Center
- Deke Slayton Cancer Center
- Texoma Cancer Center
- Northern Utah Associates
- Danville Hematology & Oncology
- Medical Oncology & Hematology Associates of Northern Virginia
- Virginia Oncology Associates
- Virginia Cancer Institute
- Highline Medical Oncology
- Providence Everett Medical Center/Providence regional Cancer Partnership
- Northwest Cancer Specialists
- University of Wisconsin
- Medical Consultants
- Medical College of Wisconsin/Division of Neoplastic & Related Disorders
- Novartis Investigative Site
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ASA404
ASA40 Placebo
Arm Description
Outcomes
Primary Outcome Measures
Overall survival rate
Secondary Outcome Measures
Overall survival of patients with squamous and non-squamous NSCLC
Full Information
NCT ID
NCT00662597
First Posted
April 17, 2008
Last Updated
December 16, 2020
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00662597
Brief Title
ASA404 or Placebo in Combination With Paclitaxel and Carboplatin as First-Line Treatment for Stage IIIb/IV Non-Small Cell Lung Cancer
Acronym
ATRACT-1
Official Title
A Phase III, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study of ASA404 in Combination With Paclitaxel and Carboplatin as First-Line Treatment for Locally Advanced or Metastatic (Stage IIIb/IV) Non-Small Cell Lung Cancer (NSCLC)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Terminated
Study Start Date
April 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
Tumor vascular disrupting agent, VDA, ASA404, non-small cell lung cancer, NSCLC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1285 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ASA404
Arm Type
Experimental
Arm Title
ASA40 Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ASA404
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Primary Outcome Measure Information:
Title
Overall survival rate
Time Frame
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 Outcome Measure Information:
Title
Overall survival of patients with squamous and non-squamous NSCLC
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Newly diagnosed Stage IIIb disease (malignant pleural effusion or pericardial effusion that have been confirmed cytologically) or Stage IV disease
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.)
Age ≥ 18 years old
WHO Performance Status of 0-1
Measurable or non-measurable disease per RECIST criteria (Post-text supplement 1)
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).
Life expectancy ≥ 12 weeks
Written informed consent obtained according to local guidelines
Exclusion Criteria:
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.).
Patients with a history of another primary malignancy ≤ 5 years, with the exception of non-melanoma 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 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 exclusion criteria. Patients must have recovered from all surgery-related complications.
Concurrent use of other investigational agents and patients who have received investigational agents ≤ 4 weeks prior to randomization
Prior exposure to Tumor-VDAs or other vascular targeting agents (anti-VEGF, anti-VEGF receptor agents, anti-EGFR agents [bevacizumab, cetuximab, etc.])
Pleural effusion that causes ≥ CTC grade 2 dyspnea
Patients with systolic BP > 160 mm Hg and/or diastolic BP >90 mm Hg
Patients with recent hemoptysis associated with NSCLC (> 1 teaspoon in a single episode within 4 weeks)
Patients with any one of the following:
Patients with long QT syndrome
Patients with a Baseline 12-lead ECG QTc of > 450 msec per central evaluation
Congestive heart failure (NY Heart Association class III or IV)
Patients with a myocardial infarction within 12 months of study entry
Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris
History of labile hypertension or poor compliance with anti-hypertensive 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 (See Table 6-3)
Known allergy or hypersensitivity to platinum-containing drugs, taxanes, other drugs formulated in Cremophor EL (polyoxyethylated castor oil) or any known excipients of these drugs.
Peripheral sensory neuropathy with functional impairment (CTC grade 2 neuropathy, regardless of causality)
Pregnant or breast feeding females
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml)
Women of child bearing potential or sexually active males, unwilling or unable to use the required highly effective method(s) of contraception for both sexes while receiving treatment and for at least 6 months after the discontinuation of study treatment. (Adequate forms of contraception include IUD, oral or depot contraceptive or the barrier method plus spermicide.)
• Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions while taking paclitaxel and therefore are not considered effective contraceptive methods for this study when used as a single agent. Therefore, it is highly recommended that a concomitant barrier method be used with oral, implantable, or injectable contraceptives. The investigator shall counsel the patient accordingly. Women of childbearing potential must have a negative pregnancy test (serum or urine) 72 hours prior to administration of study treatment. For a list of substrates of human liver microsomal P450 enzymes, visit website (http://medicine.iupui.edu/flockhart/)
Concurrent severe and/or uncontrolled medical disease (i.e. uncontrolled diabetes, chronic renal disease, chronic liver disease, confirmed diagnosis of HIV infection or active uncontrolled infection).
Significant neurologic or psychiatric disorder which could compromise participation in the study Patient unwilling or unable to comply with the protocol
Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
University of South Alabama/Mitchell Cancer Institute
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
Arizona Oncology Associates
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-5024
Country
United States
Facility Name
Highlands Oncology Group
City
Bentonville
State/Province
Arkansas
ZIP/Postal Code
72712
Country
United States
Facility Name
Genesis Cancer Center
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Alta Bates Summit Medical Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
Pacific Oncology and Hematology Association
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Cancer Care Associates
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Ronald Yanagihara - Private Practice
City
Gilroy
State/Province
California
ZIP/Postal Code
95020
Country
United States
Facility Name
California Cancer Care
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Moores UCSD Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0698
Country
United States
Facility Name
Loma Linda University Cancer Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354-3834
Country
United States
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of California Irvine Comprhensive Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Loma Linda Oncology Medical Group, Inc.
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
UC Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
California Pacific Medical Research Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Redwood Regional Cancer Center
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Palm Beach Institute of Hematology & Oncology
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33435
Country
United States
Facility Name
Florida Cancer Specialists
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Cancer Centers of Central Florida, PA
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34788
Country
United States
Facility Name
Advanced Medical Specialties (ACORN)
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Northwest Georgia Oncology Centers
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Cancer Research Center of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Kootenai Cancer Center (ACORN)
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Advocate Illinois Masonic Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Illinois Oncology/Warren Billhartz Cancer Ctr.
City
Maryville
State/Province
Illinois
ZIP/Postal Code
62062
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Hematology/Oncology of North Shore
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Loyola Cancer Care & Research Ctr. at Central Dupage Hospital
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
Facility Name
Ft. Wayne Oncology and Hematology
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46815
Country
United States
Facility Name
Siouxland Hematology-Oncology Assoc., LLC
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
Kansas City Cancer Center, Southwest
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
University of Louisville - James Graham Brown Cancer Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Hematology Oncology Specialists
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Louisiana State University Health Sciences Center - Feist-Weiller Cancer Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
St. Agnes Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21129-5299
Country
United States
Facility Name
Sinai Hospital of Baltimore - The Alvin & Lois Lapidus Cancer Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215-5271
Country
United States
Facility Name
The Harry and Jeanette Weinberg Cancer Institute at Franklin Square/MedStar Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Peninsula Regional Oncology and Hematology
City
Salisbury
State/Province
Maryland
ZIP/Postal Code
21801
Country
United States
Facility Name
Boston VA Healthcare System
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
Facility Name
Fallon Clinic
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Breslin Cancer Center
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Osteopathic Medical Oncology and Hematology PC
City
Woodhaven
State/Province
Michigan
ZIP/Postal Code
28183
Country
United States
Facility Name
St. Luke's Hospital - St Luke's Cancer Center
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55811
Country
United States
Facility Name
Kansas City Veterans Affair Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Facility Name
St. Louis University Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Center for Cancer Care and Research (US Oncology)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
St. John's Mercy Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
St. Louis Cancer and Breast Institute
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Billings Clinic
City
Billings
State/Province
Montana
ZIP/Postal Code
59107-7000
Country
United States
Facility Name
Sletten Cancer Institute
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-7680
Country
United States
Facility Name
Eastchester Center for Cancer Care
City
Bronx
State/Province
New York
ZIP/Postal Code
10469
Country
United States
Facility Name
Arena Oncology Associates
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
New York Oncology Hematology
City
Latham
State/Province
New York
ZIP/Postal Code
12210
Country
United States
Facility Name
Hematology Oncology Associates of Rockland
City
Nyack
State/Province
New York
ZIP/Postal Code
10960
Country
United States
Facility Name
Rochester General Hospital - Lipson Cancer Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States
Facility Name
Syracuse VA Medical Center
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Alamance Regional Medical Center-Cancer Ctr.
City
Burlington
State/Province
North Carolina
ZIP/Postal Code
27215
Country
United States
Facility Name
Carolina Cancer Mgmt/Cape Fear Valley Health System/Med Onc
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
Akron City Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44309-2090
Country
United States
Facility Name
Oncology Hematology Care Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Medical Oncology Hematology Associates, Inc. - Dayton Clinical Oncology Program
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Medical Oncology Hematology Associates, Inc.
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Cleo Craig Memorial Cancer Ctr. & Research Clinic
City
Lawton
State/Province
Oklahoma
ZIP/Postal Code
73505
Country
United States
Facility Name
University of Oklahoma Health Science Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Kaiser Permanente, Northwest Region
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Allegheny General Hospital/Allegheny Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
South Carolina Oncology Associate
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29210
Country
United States
Facility Name
Lowcountry Hematology & Oncology PA
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Chattanooga Oncology Hematology Associates
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37804
Country
United States
Facility Name
The West Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Oncology Cancer Center of the High Plains
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Arlington Cancer Center
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Patient's Comprehensive Cancer Center
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75010
Country
United States
Facility Name
South Texas Cancer Institute
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78405
Country
United States
Facility Name
Cancer Care Centers of South Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States
Facility Name
Texas Oncology at Presbyterian Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
University of Texas Southwestern Medical Center/Simmons Comprehensive Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9179
Country
United States
Facility Name
Texas Oncology at Garland
City
Garland
State/Province
Texas
ZIP/Postal Code
75042
Country
United States
Facility Name
HOPE Oncology
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Facility Name
Tyler Cancer Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
UT Health Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75709
Country
United States
Facility Name
Deke Slayton Cancer Center
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Texoma Cancer Center
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76310
Country
United States
Facility Name
Northern Utah Associates
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Danville Hematology & Oncology
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
Medical Oncology & Hematology Associates of Northern Virginia
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Virginia Oncology Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Virginia Cancer Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
Highline Medical Oncology
City
Burien
State/Province
Washington
ZIP/Postal Code
98166
Country
United States
Facility Name
Providence Everett Medical Center/Providence regional Cancer Partnership
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Northwest Cancer Specialists
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Medical Consultants
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Medical College of Wisconsin/Division of Neoplastic & Related Disorders
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Novartis Investigative Site
City
Buenos Aires
Country
Argentina
Facility Name
Novartis Investigative Site
City
Capital Federal
Country
Argentina
Facility Name
Novartis Investigative Site
City
Cordoba
Country
Argentina
Facility Name
Novartis Investigative Site
City
La Plata
Country
Argentina
Facility Name
Novartis Investigative Site
City
Mendoza
Country
Argentina
Facility Name
Novartis Investigative Site
City
Rosario
Country
Argentina
Facility Name
Novartis Investigative Site
City
Heidelberg
Country
Australia
Facility Name
Novartis Investigative Site
City
Herston
Country
Australia
Facility Name
Novartis Investigative Site
City
South Brisbane
Country
Australia
Facility Name
Novartis Investigative Site
City
Duffel
Country
Belgium
Facility Name
Novartis Investigative Site
City
Jette
Country
Belgium
Facility Name
Novartis Investigative Site
City
Liege
Country
Belgium
Facility Name
Novartis Investigative Site
City
Barretos
Country
Brazil
Facility Name
Novartis Investigative Site
City
Belo Horizonte
Country
Brazil
Facility Name
Novartis Investigative Site
City
Goiania
Country
Brazil
Facility Name
Novartis Investigative Site
City
Jaù
Country
Brazil
Facility Name
Novartis Investigative Site
City
Jaú
Country
Brazil
Facility Name
Novartis Investigative Site
City
Porto Alegre
Country
Brazil
Facility Name
Novartis Investigative Site
City
Santo Andre
Country
Brazil
Facility Name
Novartis Investigative Site
City
Sao Paulo
Country
Brazil
Facility Name
Novartis Investigative Site
City
São Paulo
Country
Brazil
Facility Name
Novartis Investigative Site
City
Calgary
Country
Canada
Facility Name
Novartis Investigative Site
City
Greenfield Park
Country
Canada
Facility Name
Novartis Investigative Site
City
Kitchener
Country
Canada
Facility Name
Novartis Investigative Site
City
London
Country
Canada
Facility Name
Novartis Investigative Site
City
Moncton
Country
Canada
Facility Name
Novartis Investigative Site
City
Montreal
Country
Canada
Facility Name
Novartis Investigative Site
City
Rimouski
Country
Canada
Facility Name
Novartis Investigative Site
City
Sainte-Foy
Country
Canada
Facility Name
Novartis Investigative Site
City
Sherbrooke
Country
Canada
Facility Name
Novartis Investigative Site
City
Sult Ste-Marie
Country
Canada
Facility Name
Novartis Investigative Site
City
Bejing
Country
China
Facility Name
Novartis Investigative Site
City
Guangzhou
Country
China
Facility Name
Novartis Investigative Site
City
Shanghai
Country
China
Facility Name
Novartis Investigative Site
City
Wuhan
Country
China
Facility Name
Novartis Investigative Site
City
Xi'an
Country
China
Facility Name
Novartis Investigative Site
City
Brno
Country
Czechia
Facility Name
Novartis Investigative Site
City
Ostrava Poruba
Country
Czechia
Facility Name
Novartis Investigative Site
City
Prague
Country
Czechia
Facility Name
Novartis Investigative Site
City
Bobigny
Country
France
Facility Name
Novartis Investigative Site
City
Boujan-sur-Libron
Country
France
Facility Name
Novartis Investigative Site
City
Clamart Cedex
Country
France
Facility Name
Novartis Investigative Site
City
Le Mans
Country
France
Facility Name
Novartis Investigative Site
City
Limoges
Country
France
Facility Name
Novartis Investigative Site
City
Lyon Cedex
Country
France
Facility Name
Novartis Investigative Site
City
Marseille
Country
France
Facility Name
Novartis Investigative Site
City
Nice
Country
France
Facility Name
Novartis Investigative Site
City
Paris
Country
France
Facility Name
Novartis Investigative Site
City
Saint Herblain
Country
France
Facility Name
Novartis Investigative Site
City
Toulon Armées
Country
France
Facility Name
Novartis Investigative Site
City
Tours Cedex 9
Country
France
Facility Name
Novartis Investigative Site
City
Aschaffenburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Bad Berka
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
Country
Germany
Facility Name
Novartis Investigative Site
City
Donaustauf
Country
Germany
Facility Name
Novartis Investigative Site
City
Ebensberg
Country
Germany
Facility Name
Novartis Investigative Site
City
Essen
Country
Germany
Facility Name
Novartis Investigative Site
City
Freiburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Gerlingen
Country
Germany
Facility Name
Novartis Investigative Site
City
Grosshandsdorf
Country
Germany
Facility Name
Novartis Investigative Site
City
Göttingen
Country
Germany
Facility Name
Novartis Investigative Site
City
Heidenheim
Country
Germany
Facility Name
Novartis Investigative Site
City
Koeln
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
Country
Germany
Facility Name
Novartis Investigative Site
City
Merseburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenchen
Country
Germany
Facility Name
Novartis Investigative Site
City
Nuernberg
Country
Germany
Facility Name
Novartis Investigative Site
City
Athens
Country
Greece
Facility Name
Novartis Investigative Site
City
Heraklion Crete
Country
Greece
Facility Name
Novartis Investigative Site
City
Thessaloniki
Country
Greece
Facility Name
Novartis Investigative Site
City
Hong Kong
Country
Hong Kong
Facility Name
Novartis Investigative Site
City
Budapest
Country
Hungary
Facility Name
Novartis Investigative Site
City
Deszk
Country
Hungary
Facility Name
Novartis Investigative Site
City
Mátraháza
Country
Hungary
Facility Name
Novartis Investigative Site
City
Kfar-Sava
Country
Israel
Facility Name
Novartis Investigative Site
City
Rehovot
Country
Israel
Facility Name
Novartis Investigative Site
City
Tel-Aviv
Country
Israel
Facility Name
Novartis Investigative Site
City
Tel-Hashomer
Country
Israel
Facility Name
Novartis Investigative Site
City
Zrifin
Country
Israel
Facility Name
Novartis Investigative Site
City
Avellino
Country
Italy
Facility Name
Novartis Investigative Site
City
Milano
Country
Italy
Facility Name
Novartis Investigative Site
City
Modena
Country
Italy
Facility Name
Novartis Investigative Site
City
Napoli
Country
Italy
Facility Name
Novartis Investigative Site
City
Orbassano
Country
Italy
Facility Name
Novartis Investigative Site
City
Parma
Country
Italy
Facility Name
Novartis Investigative Site
City
Perugia
Country
Italy
Facility Name
Novartis Investigative Site
City
Roma
Country
Italy
Facility Name
Novartis Investigative Site
City
Akashi
Country
Japan
Facility Name
Novartis Investigative Site
City
Fukuoka
Country
Japan
Facility Name
Novartis Investigative Site
City
Habikino
Country
Japan
Facility Name
Novartis Investigative Site
City
Hiroshima
Country
Japan
Facility Name
Novartis Investigative Site
City
Kashiwa
Country
Japan
Facility Name
Novartis Investigative Site
City
Kobe-city
Country
Japan
Facility Name
Novartis Investigative Site
City
Koto
Country
Japan
Facility Name
Novartis Investigative Site
City
Kumamoto
Country
Japan
Facility Name
Novartis Investigative Site
City
Kurashiki
Country
Japan
Facility Name
Novartis Investigative Site
City
Matsuyama
Country
Japan
Facility Name
Novartis Investigative Site
City
Nagoya
Country
Japan
Facility Name
Novartis Investigative Site
City
Niigata
Country
Japan
Facility Name
Novartis Investigative Site
City
Okayama
Country
Japan
Facility Name
Novartis Investigative Site
City
Osaka Sayama
Country
Japan
Facility Name
Novartis Investigative Site
City
Osaka
Country
Japan
Facility Name
Novartis Investigative Site
City
Sapporo
Country
Japan
Facility Name
Novartis Investigative Site
City
Sendai
Country
Japan
Facility Name
Novartis Investigative Site
City
Ube
Country
Japan
Facility Name
Novartis Investigative Site
City
Yokohama
Country
Japan
Facility Name
Novartis Investigative Site
City
Seoul
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seungnam
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Suwon
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Amsterdam
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Breda
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Eindhoven
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Harderwijk
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Hertogenbosch
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Zwolle
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Auckland
Country
New Zealand
Facility Name
Novartis Investigative Site
City
Christchurch
Country
New Zealand
Facility Name
Novartis Investigative Site
City
Hamilton
Country
New Zealand
Facility Name
Novartis Investigative Site
City
Wellington
Country
New Zealand
Facility Name
Novartis Investigative Site
City
Lodz
Country
Poland
Facility Name
Novartis Investigative Site
City
Lublin
Country
Poland
Facility Name
Novartis Investigative Site
City
Otwock
Country
Poland
Facility Name
Novartis Investigative Site
City
Poznan
Country
Poland
Facility Name
Novartis Investigative Site
City
Singapore
Country
Singapore
Facility Name
Novartis Investigative Site
City
Baracaldo
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
Country
Spain
Facility Name
Novartis Investigative Site
City
Córdoba
Country
Spain
Facility Name
Novartis Investigative Site
City
Granada
Country
Spain
Facility Name
Novartis Investigative Site
City
Jaen
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
Country
Spain
Facility Name
Novartis Investigative Site
City
Pontevedra
Country
Spain
Facility Name
Novartis Investigative Site
City
Sevilla
Country
Spain
Facility Name
Novartis Investigative Site
City
Zaragoza
Country
Spain
Facility Name
Novartis Investigative Site
City
Umea
Country
Sweden
Facility Name
Novartis Investigative Site
City
Kaoshiung
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Lin-Ko
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taichung
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Tainan
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taipei
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Altunizade
Country
Turkey
Facility Name
Novartis Investigative Site
City
Ankara
Country
Turkey
Facility Name
Novartis Investigative Site
City
Istanbul
Country
Turkey
Facility Name
Novartis Investigative Site
City
Izmir
Country
Turkey
Facility Name
Novartis Investigative Site
City
Aberdeen
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Cambridge
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Leicester
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
London
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Manchester
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Sutton
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=4609
Description
Results for CASA404A2301 from the Novartis Clinical Trials website
URL
http://www.lungcancerstudyinfo.com
Description
Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.
Learn more about this trial
ASA404 or Placebo in Combination With Paclitaxel and Carboplatin as First-Line Treatment for Stage IIIb/IV Non-Small Cell Lung Cancer
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