TerminatedPhase 2NCT01860040

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

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

Checked against the public recordLast updated Feb 7, 2018 · Source: ClinicalTrials.gov

StatusTerminated
PhasePhase 2
U.S. locations1
SponsorWestern Regional Medical Center
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Western Regional Medical Center
Interventions being studied
Drug: Cisplatin; Drug: Pemetrexed; Drug: Gemcitabine
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: 1. 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. 2. Mass must be determined to be surgically resectable 3. Eastern Cooperative Oncology Group (ECOG) performance status score \< 1 and a life expectancy \>3 months. 4. Participants must have at least one evaluable lesion as defined by RECIST 1.1 5. Absolute neutrophil count \> 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 8.5 g/dL 6. 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 7. No prior chemotherapy or radiotherapy for NSCLC 8. At least 5 years from diagnosis of another cancer except treated in-situ disease or surgically resected non-melanoma skin cancer with clear margins. 9. Willingness to provide permission to biopsy NSCLC for collection of frozen pretreatment sample. 10. 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 Criteria: 1. Active clinically serious infection \> CTCAE (version 4.03) Grade 2. 2. Serious non-healing wound, ulcer, or bone fracture. 3. Major contraindication to surgical resection of NSCLC 4. Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements. 5. Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements. 6. Patients receiving any other investigational agents. 7. Pregnant or lactating females

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Western Regional Medical CenterGoodyear, Arizona

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 7, 2018. Always confirm current availability with the study team.

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