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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)

This study has been completed.
Sponsor:
Collaborators:
Eli Lilly and Company
United States Department of Defense
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01443078
First received: September 26, 2011
Last updated: June 29, 2016
Last verified: June 2016
Results First Received: June 29, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lung Cancer
Interventions: Drug: pemetrexed plus cisplatin
Drug: vinorelbine and docetaxel

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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
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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.
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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]
 
<=18 years   0 
Between 18 and 65 years   22 
>=65 years   20 
Gender 
[Units: Participants]
 
Female   27 
Male   15 


  Outcome Measures

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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
Study First Received: September 26, 2011
Results First Received: June 29, 2016
Last Updated: June 29, 2016
Health Authority: United States: Institutional Review Board