ASA404 or Placebo in Combination With Paclitaxel and Carboplatin as First-Line Treatment for Stage IIIb/IV Non-Small Cell Lung Cancer (ATRACT-1)

December 16, 2020 updated by: Novartis Pharmaceuticals

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1285

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Novartis Investigative Site
      • Capital Federal, Argentina
        • Novartis Investigative Site
      • Cordoba, Argentina
        • Novartis Investigative Site
      • La Plata, Argentina
        • Novartis Investigative Site
      • Mendoza, Argentina
        • Novartis Investigative Site
      • Rosario, Argentina
        • Novartis Investigative Site
  • Australia
      • Heidelberg, Australia
        • Novartis Investigative Site
      • Herston, Australia
        • Novartis Investigative Site
      • South Brisbane, Australia
        • Novartis Investigative Site
  • Belgium
      • Duffel, Belgium
        • Novartis Investigative Site
      • Jette, Belgium
        • Novartis Investigative Site
      • Liege, Belgium
        • Novartis Investigative Site
  • Brazil
      • Barretos, Brazil
        • Novartis Investigative Site
      • Belo Horizonte, Brazil
        • Novartis Investigative Site
      • Goiania, Brazil
        • Novartis Investigative Site
      • Jaù, Brazil
        • Novartis Investigative Site
      • Jaú, Brazil
        • Novartis Investigative Site
      • Porto Alegre, Brazil
        • Novartis Investigative Site
      • Santo Andre, Brazil
        • Novartis Investigative Site
      • Sao Paulo, Brazil
        • Novartis Investigative Site
      • São Paulo, Brazil
        • Novartis Investigative Site
  • Canada
      • Calgary, Canada
        • Novartis Investigative Site
      • Greenfield Park, Canada
        • Novartis Investigative Site
      • Kitchener, Canada
        • Novartis Investigative Site
      • London, Canada
        • Novartis Investigative Site
      • Moncton, Canada
        • Novartis Investigative Site
      • Montreal, Canada
        • Novartis Investigative Site
      • Rimouski, Canada
        • Novartis Investigative Site
      • Sainte-Foy, Canada
        • Novartis Investigative Site
      • Sherbrooke, Canada
        • Novartis Investigative Site
      • Sult Ste-Marie, Canada
        • Novartis Investigative Site
  • China
      • Bejing, China
        • Novartis Investigative Site
      • Guangzhou, China
        • Novartis Investigative Site
      • Shanghai, China
        • Novartis Investigative Site
      • Wuhan, China
        • Novartis Investigative Site
      • Xi'an, China
        • Novartis Investigative Site
  • Czechia
      • Brno, Czechia
        • Novartis Investigative Site
      • Ostrava Poruba, Czechia
        • Novartis Investigative Site
      • Prague, Czechia
        • Novartis Investigative Site
  • France
      • Bobigny, France
        • Novartis Investigative Site
      • Boujan-sur-Libron, France
        • Novartis Investigative Site
      • Clamart Cedex, France
        • Novartis Investigative Site
      • Le Mans, France
        • Novartis Investigative Site
      • Limoges, France
        • Novartis Investigative Site
      • Lyon Cedex, France
        • Novartis Investigative Site
      • Marseille, France
        • Novartis Investigative Site
      • Nice, France
        • Novartis Investigative Site
      • Paris, France
        • Novartis Investigative Site
      • Saint Herblain, France
        • Novartis Investigative Site
      • Toulon Armées, France
        • Novartis Investigative Site
      • Tours Cedex 9, France
        • Novartis Investigative Site
  • Germany
      • Aschaffenburg, Germany
        • Novartis Investigative Site
      • Bad Berka, Germany
        • Novartis Investigative Site
      • Berlin, Germany
        • Novartis Investigative Site
      • Donaustauf, Germany
        • Novartis Investigative Site
      • Ebensberg, Germany
        • Novartis Investigative Site
      • Essen, Germany
        • Novartis Investigative Site
      • Freiburg, Germany
        • Novartis Investigative Site
      • Gerlingen, Germany
        • Novartis Investigative Site
      • Grosshandsdorf, Germany
        • Novartis Investigative Site
      • Göttingen, Germany
        • Novartis Investigative Site
      • Heidenheim, Germany
        • Novartis Investigative Site
      • Koeln, Germany
        • Novartis Investigative Site
      • Leipzig, Germany
        • Novartis Investigative Site
      • Merseburg, Germany
        • Novartis Investigative Site
      • Muenchen, Germany
        • Novartis Investigative Site
      • Nuernberg, Germany
        • Novartis Investigative Site
  • Greece
      • Athens, Greece
        • Novartis Investigative Site
      • Heraklion Crete, Greece
        • Novartis Investigative Site
      • Thessaloniki, Greece
        • Novartis Investigative Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary
        • Novartis Investigative Site
      • Deszk, Hungary
        • Novartis Investigative Site
      • Mátraháza, Hungary
        • Novartis Investigative Site
  • Israel
      • Kfar-Sava, Israel
        • Novartis Investigative Site
      • Rehovot, Israel
        • Novartis Investigative Site
      • Tel-Aviv, Israel
        • Novartis Investigative Site
      • Tel-Hashomer, Israel
        • Novartis Investigative Site
      • Zrifin, Israel
        • Novartis Investigative Site
  • Italy
      • Avellino, Italy
        • Novartis Investigative Site
      • Milano, Italy
        • Novartis Investigative Site
      • Modena, Italy
        • Novartis Investigative Site
      • Napoli, Italy
        • Novartis Investigative Site
      • Orbassano, Italy
        • Novartis Investigative Site
      • Parma, Italy
        • Novartis Investigative Site
      • Perugia, Italy
        • Novartis Investigative Site
      • Roma, Italy
        • Novartis Investigative Site
  • Japan
      • Akashi, Japan
        • Novartis Investigative Site
      • Fukuoka, Japan
        • Novartis Investigative Site
      • Habikino, Japan
        • Novartis Investigative Site
      • Hiroshima, Japan
        • Novartis Investigative Site
      • Kashiwa, Japan
        • Novartis Investigative Site
      • Kobe-city, Japan
        • Novartis Investigative Site
      • Koto, Japan
        • Novartis Investigative Site
      • Kumamoto, Japan
        • Novartis Investigative Site
      • Kurashiki, Japan
        • Novartis Investigative Site
      • Matsuyama, Japan
        • Novartis Investigative Site
      • Nagoya, Japan
        • Novartis Investigative Site
      • Niigata, Japan
        • Novartis Investigative Site
      • Okayama, Japan
        • Novartis Investigative Site
      • Osaka, Japan
        • Novartis Investigative Site
      • Osaka Sayama, Japan
        • Novartis Investigative Site
      • Sapporo, Japan
        • Novartis Investigative Site
      • Sendai, Japan
        • Novartis Investigative Site
      • Ube, Japan
        • Novartis Investigative Site
      • Yokohama, Japan
        • Novartis Investigative Site
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Novartis Investigative Site
      • Seungnam, Korea, Republic of
        • Novartis Investigative Site
      • Suwon, Korea, Republic of
        • Novartis Investigative Site
  • Netherlands
      • Amsterdam, Netherlands
        • Novartis Investigative Site
      • Breda, Netherlands
        • Novartis Investigative Site
      • Eindhoven, Netherlands
        • Novartis Investigative Site
      • Harderwijk, Netherlands
        • Novartis Investigative Site
      • Hertogenbosch, Netherlands
        • Novartis Investigative Site
      • Zwolle, Netherlands
        • Novartis Investigative Site
  • New Zealand
      • Auckland, New Zealand
        • Novartis Investigative Site
      • Christchurch, New Zealand
        • Novartis Investigative Site
      • Hamilton, New Zealand
        • Novartis Investigative Site
      • Wellington, New Zealand
        • Novartis Investigative Site
  • Poland
      • Lodz, Poland
        • Novartis Investigative Site
      • Lublin, Poland
        • Novartis Investigative Site
      • Otwock, Poland
        • Novartis Investigative Site
      • Poznan, Poland
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore
        • Novartis Investigative Site
  • Spain
      • Baracaldo, Spain
        • Novartis Investigative Site
      • Barcelona, Spain
        • Novartis Investigative Site
      • Córdoba, Spain
        • Novartis Investigative Site
      • Granada, Spain
        • Novartis Investigative Site
      • Jaen, Spain
        • Novartis Investigative Site
      • Madrid, Spain
        • Novartis Investigative Site
      • Pontevedra, Spain
        • Novartis Investigative Site
      • Sevilla, Spain
        • Novartis Investigative Site
      • Zaragoza, Spain
        • Novartis Investigative Site
  • Sweden
      • Umea, Sweden
        • Novartis Investigative Site
  • Taiwan
      • Kaoshiung, Taiwan
        • Novartis Investigative Site
      • Lin-Ko, Taiwan
        • Novartis Investigative Site
      • Taichung, Taiwan
        • Novartis Investigative Site
      • Tainan, Taiwan
        • Novartis Investigative Site
      • Taipei, Taiwan
        • Novartis Investigative Site
  • Turkey
      • Altunizade, Turkey
        • Novartis Investigative Site
      • Ankara, Turkey
        • Novartis Investigative Site
      • Istanbul, Turkey
        • Novartis Investigative Site
      • Izmir, Turkey
        • Novartis Investigative Site
  • United Kingdom
      • Aberdeen, United Kingdom
        • Novartis Investigative Site
      • Cambridge, United Kingdom
        • Novartis Investigative Site
      • Leicester, United Kingdom
        • Novartis Investigative Site
      • London, United Kingdom
        • Novartis Investigative Site
      • Manchester, United Kingdom
        • Novartis Investigative Site
      • Sutton, United Kingdom
        • Novartis Investigative Site
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36604
        • University of South Alabama/Mitchell Cancer Institute
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Arizona Oncology Associates
      • Tucson, Arizona, United States, 85724-5024
        • University of Arizona Cancer Center
    • Arkansas
      • Bentonville, Arkansas, United States, 72712
        • Highlands Oncology Group
      • Hot Springs, Arkansas, United States, 71913
        • Genesis Cancer Center
    • California
      • Berkeley, California, United States, 94704
        • Alta Bates Summit Medical Center
      • Encinitas, California, United States, 92024
        • Pacific Oncology and Hematology Association
      • Fresno, California, United States, 93720
        • Cancer Care Associates
      • Gilroy, California, United States, 95020
        • Ronald Yanagihara - Private Practice
      • Greenbrae, California, United States, 94904
        • California Cancer Care
      • La Jolla, California, United States, 92093-0698
        • Moores UCSD Cancer Center
      • Loma Linda, California, United States, 92354-3834
        • Loma Linda University Cancer Center
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center
      • Orange, California, United States, 92868
        • University of California Irvine Comprhensive Center
      • Redlands, California, United States, 92374
        • Loma Linda Oncology Medical Group, Inc.
      • Sacramento, California, United States, 95817
        • UC Davis Comprehensive Cancer Center
      • San Francisco, California, United States, 94115
        • California Pacific Medical Research Institute
      • Santa Rosa, California, United States, 95403
        • Redwood Regional Cancer Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Hospital
    • Florida
      • Boynton Beach, Florida, United States, 33435
        • Palm Beach Institute of Hematology & Oncology
      • Bradenton, Florida, United States, 34209
        • Florida Cancer Specialists
      • Leesburg, Florida, United States, 34788
        • Cancer Centers of Central Florida, PA
      • Miami, Florida, United States, 33176
        • Advanced Medical Specialties (ACORN)
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Northwest Georgia Oncology Centers
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Cancer Research Center of Hawaii
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
        • Kootenai Cancer Center (ACORN)
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Advocate Illinois Masonic Medical Center
      • Maryville, Illinois, United States, 62062
        • Illinois Oncology/Warren Billhartz Cancer Ctr.
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
      • Skokie, Illinois, United States, 60076
        • Hematology/Oncology of North Shore
      • Winfield, Illinois, United States, 60190
        • Loyola Cancer Care & Research Ctr. at Central Dupage Hospital
    • Indiana
      • Fort Wayne, Indiana, United States, 46815
        • Ft. Wayne Oncology and Hematology
    • Iowa
      • Sioux City, Iowa, United States, 51101
        • Siouxland Hematology-Oncology Assoc., LLC
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Kansas City Cancer Center, Southwest
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville - James Graham Brown Cancer Center
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Hematology Oncology Specialists
      • Shreveport, Louisiana, United States, 71103
        • Louisiana State University Health Sciences Center - Feist-Weiller Cancer Center
    • Maryland
      • Baltimore, Maryland, United States, 21129-5299
        • St. Agnes Cancer Center
      • Baltimore, Maryland, United States, 21215-5271
        • Sinai Hospital of Baltimore - The Alvin & Lois Lapidus Cancer Institute
      • Baltimore, Maryland, United States, 21237
        • The Harry and Jeanette Weinberg Cancer Institute at Franklin Square/MedStar Health
      • Salisbury, Maryland, United States, 21801
        • Peninsula Regional Oncology and Hematology
    • Massachusetts
      • Boston, Massachusetts, United States, 02130
        • Boston VA Healthcare System
      • Worcester, Massachusetts, United States, 01605
        • Fallon Clinic
    • Michigan
      • Lansing, Michigan, United States, 48910
        • Breslin Cancer Center
      • Woodhaven, Michigan, United States, 28183
        • Osteopathic Medical Oncology and Hematology PC
    • Minnesota
      • Duluth, Minnesota, United States, 55811
        • St. Luke's Hospital - St Luke's Cancer Center
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Kansas City Veterans Affair Medical Center
      • Saint Louis, Missouri, United States, 63110
        • St. Louis University Cancer Center
      • Saint Louis, Missouri, United States, 63141
        • St. John's Mercy Medical Center
      • Saint Louis, Missouri, United States, 63141
        • Center for Cancer Care and Research (US Oncology)
      • Saint Louis, Missouri, United States, 63141
        • St. Louis Cancer and Breast Institute
    • Montana
      • Billings, Montana, United States, 59107-7000
        • Billings Clinic
      • Great Falls, Montana, United States, 59405
        • Sletten Cancer Institute
    • Nebraska
      • Omaha, Nebraska, United States, 68198-7680
        • University of Nebraska Medical Center
    • New York
      • Bronx, New York, United States, 10469
        • Eastchester Center for Cancer Care
      • Lake Success, New York, United States, 11042
        • Arena Oncology Associates
      • Latham, New York, United States, 12210
        • New York Oncology Hematology
      • Nyack, New York, United States, 10960
        • Hematology Oncology Associates of Rockland
      • Rochester, New York, United States, 14621
        • Rochester General Hospital - Lipson Cancer Center
      • Syracuse, New York, United States, 13210
        • Syracuse VA Medical Center
    • North Carolina
      • Burlington, North Carolina, United States, 27215
        • Alamance Regional Medical Center-Cancer Ctr.
      • Fayetteville, North Carolina, United States, 28304
        • Carolina Cancer Mgmt/Cape Fear Valley Health System/Med Onc
    • Ohio
      • Akron, Ohio, United States, 44309-2090
        • Akron City Hospital
      • Cincinnati, Ohio, United States, 45242
        • Oncology Hematology Care Research
      • Cleveland, Ohio, United States, 44106
        • University Hospitals of Cleveland
      • Dayton, Ohio, United States, 45429
        • Medical Oncology Hematology Associates, Inc. - Dayton Clinical Oncology Program
      • Dayton, Ohio, United States, 45429
        • Medical Oncology Hematology Associates, Inc.
    • Oklahoma
      • Lawton, Oklahoma, United States, 73505
        • Cleo Craig Memorial Cancer Ctr. & Research Clinic
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Science Center
    • Oregon
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente, Northwest Region
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital/Allegheny Cancer Center
    • South Carolina
      • Columbia, South Carolina, United States, 29210
        • South Carolina Oncology Associate
      • Mount Pleasant, South Carolina, United States, 29464
        • Lowcountry Hematology & Oncology PA
    • Tennessee
      • Chattanooga, Tennessee, United States, 37804
        • Chattanooga Oncology Hematology Associates
      • Memphis, Tennessee, United States, 38120
        • The West Clinic
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology
    • Texas
      • Amarillo, Texas, United States, 79106
        • Texas Oncology Cancer Center of the High Plains
      • Arlington, Texas, United States, 76012
        • Arlington Cancer Center
      • Carrollton, Texas, United States, 75010
        • Patient's Comprehensive Cancer Center
      • Corpus Christi, Texas, United States, 78405
        • South Texas Cancer Institute
      • Dallas, Texas, United States, 75204
        • Cancer Care Centers of South Texas
      • Dallas, Texas, United States, 75231
        • Texas Oncology at Presbyterian Hospital
      • Dallas, Texas, United States, 75390-9179
        • University of Texas Southwestern Medical Center/Simmons Comprehensive Cancer Center
      • Garland, Texas, United States, 75042
        • Texas Oncology at Garland
      • Richardson, Texas, United States, 75080
        • HOPE Oncology
      • Tyler, Texas, United States, 75702
        • Tyler Cancer Center
      • Tyler, Texas, United States, 75709
        • UT Health Center
      • Webster, Texas, United States, 77598
        • Deke Slayton Cancer Center
      • Wichita Falls, Texas, United States, 76310
        • Texoma Cancer Center
    • Utah
      • Ogden, Utah, United States, 84403
        • Northern Utah Associates
    • Virginia
      • Danville, Virginia, United States, 24541
        • Danville Hematology & Oncology
      • Fairfax, Virginia, United States, 22031
        • Medical Oncology & Hematology Associates of Northern Virginia
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates
      • Richmond, Virginia, United States, 23230
        • Virginia Cancer Institute
    • Washington
      • Burien, Washington, United States, 98166
        • Highline Medical Oncology
      • Everett, Washington, United States, 98201
        • Providence Everett Medical Center/Providence regional Cancer Partnership
      • Vancouver, Washington, United States, 98684
        • Northwest Cancer Specialists
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Medical Consultants
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin/Division of Neoplastic & Related Disorders

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 exclusion criteria. Patients must have recovered from all surgery-related complications.
  5. Concurrent use of other investigational agents and patients who have received investigational agents ≤ 4 weeks prior to randomization
  6. Prior exposure to Tumor-VDAs or other vascular targeting agents (anti-VEGF, anti-VEGF receptor agents, anti-EGFR agents [bevacizumab, cetuximab, etc.])
  7. Pleural effusion that causes ≥ CTC grade 2 dyspnea
  8. Patients with systolic BP > 160 mm Hg and/or diastolic BP >90 mm Hg
  9. Patients with recent hemoptysis associated with NSCLC (> 1 teaspoon in a single episode within 4 weeks)

  10. 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
  11. Concomitant use of drugs with a risk of causing Torsades de Pointes (See Table 6-3)
  12. 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.
  13. Peripheral sensory neuropathy with functional impairment (CTC grade 2 neuropathy, regardless of causality)

  14. 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)

  15. 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/)

  16. 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).
  17. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ASA404
Drug: carboplatin
Drug: Paclitaxel
Drug: ASA404
PLACEBO_COMPARATOR: ASA40 Placebo
Drug: carboplatin
Drug: Placebo
Drug: Paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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 Measures

Outcome Measure
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

May 1, 2010

Study Registration Dates

First Submitted

April 17, 2008

First Submitted That Met QC Criteria

April 17, 2008

First Posted (ESTIMATE)

April 21, 2008

Study Record Updates

Last Update Posted (ACTUAL)

December 24, 2020

Last Update Submitted That Met QC Criteria

December 16, 2020

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASA404A2301

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