Lung Cancer Clinical Trial
Phase 3 Study of Tavocept Versus Placebo in Patients With Newly Diagnosed or Relapsed Advanced Primary Adenocarcinoma of the Lung Treated With Docetaxel or Paclitaxel Plus Cisplatin
Summary
Tavocept is an investigational drug that is being developed to see if it can increase the survival of patients who are being treated with chemotherapy as well as to see if it can prevent or reduce side effects of chemotherapy. This research study is aimed at trying to find out if people with advanced adenocarcinoma of the lung who are treated with a standard combination of chemotherapy drugs will live longer if they are also treated with an investigational drug called "Tavocept." Another objective of this research study is to find out whether or not Tavocept helps to prevent or reduce side-effects like kidney damage, anemia, and nausea and vomiting that can occur with these drug combinations. The drug combinations that will be used in this research study will include either paclitaxel and cisplatin, or docetaxel and cisplatin. These drug combinations are approved to be used to treat people with advanced NSCLC. Every patient on this research study will be treated with standard chemotherapy for primary NSCLC in the form of either docetaxel or paclitaxel (these will be recommended by your research study doctor), which will be given in combination with cisplatin.
Eligibility Criteria
Inclusion Criteria:
Confirmed histopathological diagnosis of inoperable advanced primary adenocarcinoma (including bronchioalveolar cell carcinoma) of the lung
No prior systemic treatment for non-small cell lung cancer including chemotherapy, immunotherapy, hormonal therapy, targeted therapies or investigational drugs
Exclusion Criteria:
Small cell, squamous cell, large cell or undifferentiated or any form of mixed (eg, small cell and adenocarcinoma or squamous and adenocarcinoma) histopathological or cytological diagnosis of primary lung cancer
Adenocarcinoma arising from primary sites other than the lung
Patients without documented Stage 4 disease (in accordance with AJCC TMM Staging System 7th edition)
Patients with unstable CNS mets within 21 days before randomization
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There are 42 Locations for this study
Birmingham Alabama, 35216, United States
Columbia Missouri, 65203, United States
Philadelphia Pennsylvania, 19107, United States
Germantown Tennessee, 38138, United States
Gabrovo , 5300, Bulgaria
Plovidv , 4004, Bulgaria
Sofia , 1233, Bulgaria
Sofia , 1756, Bulgaria
Veliko Tarnovo , 5000, Bulgaria
Elblag , 82-30, Poland
Szczecin , 70-89, Poland
Torun , 87-10, Poland
Warsaw , 01-13, Poland
Brasov , 50036, Romania
Bucharest , 02232, Romania
Cluj Napoca , 40001, Romania
Craiova , 20053, Romania
Timisoara , 30023, Romania
Arkangelsk , 16304, Russian Federation
Chelyabinsk , 45407, Russian Federation
Ekaterinburg , 62003, Russian Federation
Krasnodar Krai , 35405, Russian Federation
Krasnodar , 35008, Russian Federation
Kursk , 30503, Russian Federation
Moscow , 12135, Russian Federation
Novosibirsk , 63004, Russian Federation
Omsk , 64401, Russian Federation
Saint Petersburg , 19702, Russian Federation
St. Petersburg , 19429, Russian Federation
St. Petersburg , 19702, Russian Federation
Stavropol Krai , 35750, Russian Federation
Stavropol , 35504, Russian Federation
Tambov , 39201, Russian Federation
Voronezh , 39400, Russian Federation
Yaroslavl , 15004, Russian Federation
Chernihiv , 14029, Ukraine
Dnipropetrovsk , 49102, Ukraine
Donetsk , 83092, Ukraine
Kharkiv , 61070, Ukraine
Kherson , 73000, Ukraine
Sumy , 40000, Ukraine
Uzhorod , 88011, Ukraine
Zaporiahya , 69040, Ukraine
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