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Phase II Study of First-Line Therapy With Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

Phase II Study of First-Line Therapy With Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer

Upon determination of eligibility, patients will be receive:

- Pemetrexed + Gemcitabine

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

- Histologically confirmed non-small cell bronchogenic carcinoma

- Newly diagnosed or recurrent unresectable stage III or stage IV disease

- No mixed tumors with small cell anaplastic elements

- Measurable disease

- Must not have received any prior antineoplastic chemotherapy for lung cancer

- Age > 18 years

- Able to perform activities of daily living with little or no assistance

- Adequate bone marrow, liver and kidney

- Understand the nature of this study and give written informed consent.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

- Female patients who are pregnant or are lactating

- History of serious cardiovascular disease within the previous six months

- Serious active infection at the time of treatment

- Other serious underlying medical condition

Please note: There are additional inclusion/exclusion criteria. The study center will
determine if you meet all of the criteria. If you do not qualify for the trial, study
personnel will explain the reasons. If you do qualify, study personnel will explain the
trial in detail and answer any questions you may have.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response Rate

Outcome Description:

Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

David R. Spigel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute


United States: Institutional Review Board

Study ID:




Start Date:

May 2005

Completion Date:

August 2009

Related Keywords:

  • Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Tennessee Oncology Nashville, Tennessee  37203