NCT01860040

Neoadjuvant Chemo for Non-metastatic Non-small Cell Lung Cancer

Neoadjuvant Chemotherapy for Non-metastatic Non-small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Western Regional Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine the rate of pathologic complete responses (pCR) at the time of definitive surgical resection of non-small cell lung cancer (NSCLC)

Detailed description

Participants in this study will have a lung mass and are undergoing a procedure to determine if they have non-small cell lung cancer that could be removed surgically. If confirmed to have non-small cell lung cancer that can be surgically removed, he or she may be able to continue as a possible participant in this study. The purpose of this study is to determine whether neoadjuvant chemotherapy (chemotherapy that is given before surgery) will improve the amount of time a participant is free from disease in people with non-metastatic (has not spread from the original site) non-small cell lung cancer. The chemotherapy medications that will be used in this study are cisplatin and pemetrexed or cisplatin and gemcitabine and have been shown to be effective in patients with non-small cell lung cancer.

Conditions

• Non-squamous Cell Non-Metastatic Non-Small Cell Lung Cancer
• Squamous Cell Non-Metastatic Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Cisplatin	Alkylating antineoplastic agent (Chemotherapy)
DRUG	Pemetrexed	Antimetabolite antineoplastic agent (Chemotherapy)
DRUG	Gemcitabine	Antimetabolite antineoplastic agent (Chemotherapy)

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-09-01
• Completion: 2016-04-01
• First posted: 2013-05-22
• Last updated: 2018-02-07
• Results posted: 2017-10-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study