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

History of Changes

Results First Received: June 29, 2016

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; 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

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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 ]

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2. Secondary:

Overall Response Rate [ Time Frame: 2 years ]

Results not yet reported. Anticipated Reporting Date: No text entered.

Serious Adverse Events

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Other Adverse Events

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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

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