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CompletedPhase 2NCT00193414
Official study title

Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer

Study summary

This study is designed to study the role of an active and well-tolerated non-platinum agent, gemcitabine, in a combination regimen with pemetrexed in the first-line treatment of advanced NSCLC. This study will serve to define the role of next generation agents in a new combination regimen in the treatment of advanced NSCLC. This combination regimen may ultimately be important in further expanding treatment options for patients while improving survival, quality of life, and symptom control compared with platinum-based combination regimens - and with acceptable toxicity.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPemetrexed and Gemcitabine

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 3, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?SCRI Development Innovations, LLC

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
SCRI Development Innovations, LLC
Interventions being studied
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.

Cancer type
Non-small cell lung cancer (NSCLC)→
Treatment approach
Chemotherapy→
Study topics
Survivorship and quality of life→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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/

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

  • Tennessee OncologyNashville, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 3, 2022. Always confirm current availability with the study team.

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