Status:
TERMINATED
Neoadjuvant Chemo for Non-metastatic Non-small Cell Lung Cancer
Lead Sponsor:
Western Regional Medical Center
Conditions:
Non-squamous Cell Non-Metastatic Non-Small Cell Lung Cancer
Squamous Cell Non-Metastatic Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ce...
Eligibility Criteria
Inclusion
- Patients ≥ 18 years of age with either a mass suspicious for or histologically confirmed AJCC stage IB-IIIA NSCLC. For those without histologic confirmation of NSCLC, a biopsy will be done and only those patients with histologically confirmed NSCLC meeting all other eligibility criteria may proceed on protocol.
- Mass must be determined to be surgically resectable
- Eastern Cooperative Oncology Group (ECOG) performance status score \< 1 and a life expectancy \>3 months.
- Participants must have at least one evaluable lesion as defined by RECIST 1.1
- Absolute neutrophil count \> 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 8.5 g/dL
- Serum creatinine ≤1.3 mg/dL (candidate for cisplatin chemotherapy), total bilirubin ≤ 2 mg/dL, AST/ALT ≤ 5 times the upper limit of normal range
- No prior chemotherapy or radiotherapy for NSCLC
- At least 5 years from diagnosis of another cancer except treated in-situ disease or surgically resected non-melanoma skin cancer with clear margins.
- Willingness to provide permission to biopsy NSCLC for collection of frozen pretreatment sample.
- Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must be willing to use an acceptable contraceptive method (abstinence, oral contraceptive or double barrier method) for the duration of the study and for 30 days following the last dose of study drug, and must have a negative urine or serum pregnancy test within 2 weeks prior to beginning treatment on this trial
Exclusion
- Active clinically serious infection \> CTCAE (version 4.03) Grade 2.
- Serious non-healing wound, ulcer, or bone fracture.
- Major contraindication to surgical resection of NSCLC
- Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements.
- Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements.
- Patients receiving any other investigational agents.
- Pregnant or lactating females
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01860040
Start Date
April 1 2013
End Date
April 1 2016
Last Update
February 7 2018
Active Locations (1)
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1
Western Regional Medical Center
Goodyear, Arizona, United States, 85338