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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 : August 9, 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 Allocation: N/A;   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
Enrollment 42
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Patients
Hide Arm/Group Description Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer
Period Title: Overall Study
Started 42
Completed 13
Not Completed 29
Reason Not Completed
Responded to neoadjuvant platinum txt             27
Withdrawal by Subject             1
Patient had brain mets             1
Arm/Group Title All Patients
Hide Arm/Group Description Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer
Overall Number of Baseline Participants 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
<=18 years
0
   0.0%
Between 18 and 65 years
22
  52.4%
>=65 years
20
  47.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
Female
27
  64.3%
Male
15
  35.7%
1.Primary Outcome
Title PERCIST Partial Metabolic Response
Hide Description The primary endpoint was partial metabolic response after 2 cycles of "switch" therapy as assessed by PERCIST (SUVmax decrease ≥30% using the pre-switch scan as new baseline).
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: participants
6
2.Secondary Outcome
Title Pathologic Response Rate
Hide Description The percentage of patients with a major pathologic response
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer
Overall Number of Participants Analyzed 36
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
17
(6 to 33)
Time Frame [Not Specified]
Adverse Event Reporting Description There was not a comparative toxicity analysis done. CTCAE toxicities were collected for all patients. A comparative toxicity of those patients who switched versus those who did not was not seen as clinically relevant. Hematologic toxicities are anticipated with all chemotherapy.
 
Arm/Group Title All Patients
Hide Arm/Group Description Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer
All-Cause Mortality
All Patients
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
All Patients
Affected / at Risk (%)
Total   4/42 (9.52%) 
Cardiac disorders   
Sinus tachycardia  1  1/42 (2.38%) 
Gastrointestinal disorders   
Anorectal infection  1  1/42 (2.38%) 
Diarrhea  1  1/42 (2.38%) 
General disorders   
Dyspnea  1  1/42 (2.38%) 
Febrile neutropenia  1  1/42 (2.38%) 
Metabolism and nutrition disorders   
Dehydration  1  1/42 (2.38%) 
Hypokalemia  1  1/42 (2.38%) 
Respiratory, thoracic and mediastinal disorders   
Thromboembolic event  1  1/42 (2.38%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-4.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Patients
Affected / at Risk (%)
Total   34/42 (80.95%) 
Blood and lymphatic system disorders   
Neutrophil count decreased  1  11/42 (26.19%) 
White blood cell decreased  1  11/42 (26.19%) 
Lymphocyte count decreased  1  9/42 (21.43%) 
Cardiac disorders   
Hypertension  1  3/42 (7.14%) 
General disorders   
Fatigue  1  7/42 (16.67%) 
Metabolism and nutrition disorders   
Hyperglycemia  1  23/42 (54.76%) 
Hyperglycemia  1  13/42 (30.95%) 
Hypophosphatemia  1  7/42 (16.67%) 
Hyponatremia  1  7/42 (16.67%) 
Anemia  1  6/42 (14.29%) 
Hypoalbuminemia  1  3/42 (7.14%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-4.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chaft, Jamie, MD
Organization: Memorial Sloan Kettering Cancer Center
Phone: 646-888-4545
EMail: ChaftJ@mskcc.org
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01443078    
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: August 9, 2018