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Neoadjuvant Platinum-based Chemotherapy for Patients With Resectable , Non-small Cell Lung Cancer With Switch to Chemotherapy Alternative in Nonresponders (NEOSCAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01443078
Recruitment Status : Completed
First Posted : September 29, 2011
Results First Posted : August 9, 2016
Last Update Posted : February 20, 2018
Sponsor:
Collaborators:
Eli Lilly and Company
United States Department of Defense
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Lung Cancer
Interventions: Drug: pemetrexed
Drug: cisplatin
Drug: Carboplatin
Drug: Gemcitabine Hydrochloride
Drug: Vinorelbine Tartrate
Drug: Docetaxel

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
All Patients Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer

Participant Flow:   Overall Study
    All Patients
STARTED   42 
COMPLETED   13 
NOT COMPLETED   29 
Responded to neoadjuvant platinum txt                27 
Withdrawal by Subject                1 
Patient had brain mets                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Patients Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer

Baseline Measures
   All Patients 
Overall Participants Analyzed 
[Units: Participants]
 		 42 
Age 
[Units: Participants]
Count of Participants 		 
<=18 years      0   0.0% 
Between 18 and 65 years      22  52.4% 
>=65 years      20  47.6% 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		 
Female      27  64.3% 
Male      15  35.7% 


  Outcome Measures

1.  Primary:   PERCIST Partial Metabolic Response   [ Time Frame: 2 years ]
  Show Outcome Measure 1

2.  Secondary:   Overall Response Rate   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Chaft, Jamie, MD
Organization: Memorial Sloan Kettering Cancer Center
phone: 646-888-4545
e-mail: ChaftJ@mskcc.org



Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01443078     History of Changes
Other Study ID Numbers: 11-106
First Submitted: September 26, 2011
First Posted: September 29, 2011
Results First Submitted: June 29, 2016
Results First Posted: August 9, 2016
Last Update Posted: February 20, 2018