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

• 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: Memorial Sloan Kettering Cancer Center
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	All Patients
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

Baseline Characteristics

Arm/Group Title		All Patients
Arm/Group Description		Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer
Overall Number of Baseline Participants		42
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%

Outcome Measures

1. Primary Outcome

Title	PERCIST Partial Metabolic Response
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Patients
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
Description	The percentage of patients with a major pathologic response
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Patients
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)

Adverse Events

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
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	--/--
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
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

Limitations and Caveats

[Not Specified]

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
• EMail: ChaftJ@mskcc.org

• 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