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Completed

NCT Number: NCT00069875

A Study With Gemcitabine, Cisplatin, and LY293111 in Non-Small Cell Lung Cancer

The purpose of this study is to determine the effectiveness and side effects of LY293111 given in combination with gemcitabine and cisplatin in patients with non-small cell lung cancer.

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Ottawa, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non-Small Cell Lung Cancer, Stage IIIB or IV that is not amenable to either surgery of curative intent or radiation therapy
  • Tumor that can be measured by x-ray or scan
  • Adequate organ function

Exclusion criteria

  • Inability to swallow capsules
  • Documented brain metastases
  • Prior chemotherapy or biological therapy for this disease

Treatment and study plan

Gemcitabine

Drug

LY293111

Drug

Cisplatin

Drug

Primary outcomes

  1. To determine if progression-free survival in patients with Stage IIIB or IV NSCLC receiving gemcitabine and cisplatin can be improved by adding 200 or 600 mg BID of LY293111 as compared to placebo.

Secondary outcomes

  1. time-to-event efficacy (overall survival, duration of response, time-to-response, time-to-treatment failure)

  2. tumor response rate

  3. toxicity rates

  4. exposure-response relationship

  5. quality of life

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Randomized, Placebo-Controlled, Double-Blind, Phase 2 Study of Gemcitabine-Cisplatin Combined With Two Different Doses of LY293111 or Placebo in Patients With Stage IIIB or IV Non-Small Cell Lung Cancer

Important dates

Study start
2003
Study completion
2005
First posted
Oct 6, 2003
Registry last updated
Dec 21, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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