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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01860040
Recruitment Status : Terminated (Poor accrual, no data to analyze)
First Posted : May 22, 2013
Results First Posted : October 25, 2017
Last Update Posted : February 7, 2018
Information provided by (Responsible Party):
Western Regional Medical Center

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)

Condition or disease Intervention/treatment Phase
Non-squamous Cell Non-Metastatic Non-Small Cell Lung Cancer Squamous Cell Non-Metastatic Non-Small Cell Lung Cancer Drug: Cisplatin Drug: Pemetrexed Drug: Gemcitabine Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant Chemotherapy for Non-metastatic Non-small Cell Lung Cancer
Study Start Date : April 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Cisplatin and pemetrexed
Cisplatin on day 1 and pemetrexed on day 1, 1 cycle = 21 days, deliver 4 neoadjuvant cycles
Drug: Cisplatin
Alkylating antineoplastic agent (Chemotherapy)
Other Name: Platinol®

Drug: Pemetrexed
Antimetabolite antineoplastic agent (Chemotherapy)
Other Name: Alimta®

Experimental: Cisplatin and gemcitabine
Cisplatin on day 1 and gemcitabine on days 1 and 8, 1 cycle = 21 days, deliver 4 neoadjuvant cycles
Drug: Cisplatin
Alkylating antineoplastic agent (Chemotherapy)
Other Name: Platinol®

Drug: Gemcitabine
Antimetabolite antineoplastic agent (Chemotherapy)
Other Name: Gemzar®

Primary Outcome Measures :
  1. Rate of Pathologic Complete Responses (pCR) at the Time of Definitive Surgical Resection of Non-small Cell Lung Cancer [ Time Frame: One year ]
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by Magnetic Resonance Imagery (MRI): Complete Response (CR), Disappearance of all target lesions

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01860040

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United States, Arizona
Western Regional Medical Center
Goodyear, Arizona, United States, 85338
Sponsors and Collaborators
Western Regional Medical Center
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Principal Investigator: Glen Weiss, MD Western Regional Medical Center
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Responsible Party: Western Regional Medical Center Identifier: NCT01860040    
Other Study ID Numbers: 13-04
First Posted: May 22, 2013    Key Record Dates
Results First Posted: October 25, 2017
Last Update Posted: February 7, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors