A Study of Advanced or Metastatic Non-small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00988858
First received: September 30, 2009
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

The primary purpose of this study is to evaluate the safety of LY2603618 in combination with pemetrexed and any side effects that might be associated with it along with determining the effects of LY2603618 in combination with pemetrexed in patients with advanced or metastatic Non-small Cell Lung Cancer (NSCLC).


Condition Intervention Phase
Non Small Cell Lung Cancer
Drug: LY2603618
Drug: Pemetrexed
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study to Evaluate LY2603618 in Combination With Pemetrexed in Patients With Advanced or Metastatic Non-small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Overall Tumor Response [ Time Frame: Baseline, Near the End of Cycle 2 and Near the End of Every Other Cycle thereafter until Progressive Disease or Study Discontinuation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Patients Who Achieved a Best Response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) [ Time Frame: Baseline, Near the End of Cycle 2 and Near the End of Every Other Cycle thereafter until Progressive Disease or Study Discontinuation ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS) [ Time Frame: Baseline to Near the End of Cycle 2 and Near the End of Every Other Cycle thereafter until Progressive Disease or Study Discontinuation ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: Baseline, Near the End of Cycle 2 and Near the End of Every Other Cycle thereafter until Progressive Disease or Study Discontinuation ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area Under Curve (AUC) of LY2603618 and Pemetrexed [ Time Frame: Predose through Cycle 2 at Specified Timepoints ] [ Designated as safety issue: No ]
  • Change in Symptom Burden Scores of Lung Cancer Symptom Scale (LCSS) [ Time Frame: Baseline through Progressive Disease or Study Discontinuation ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2603618 and Pemetrexed [ Time Frame: Predose through Cycle 2 at Specified Timepoints ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2009
Estimated Study Completion Date: April 2015
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2603618 and Pemetrexed Drug: LY2603618
150 mg/m2 intravenously on Day 2 of each 21 day cycle repeating every 21 days for a minimum of 2 cycles continuing until disease progression
Drug: Pemetrexed
500mg/m2 intravenously on Day 1 of each 21 Day cycle repeating every 21 days for a minimum of 2 cycles or until disease progression
Other Names:
  • Alimta
  • LY231514

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must agree to have a tumor biopsy at screening
  • Must have a diagnosis of advanced or metastatic non-squamous non-small cell lung cancer that has progressed after certain prior treatment
  • Must be available for the duration of the study and willing to follow the study procedures
  • If participant is a woman that is capable of having children, must have a negative pregnancy test within 7 days of taking first dose of study drug
  • Must have discontinued radiation therapy at least 4 weeks before entering this study

Exclusion Criteria:

  • Must not have taken an unapproved drug as treatment for any indication within the last 28 days before starting study treatment.
  • Must not be pregnant or lactating, are considering becoming pregnant, or are considering fathering a child. Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial until the patient's physician considers it safe to become pregnant or father a child.
  • Must not have known positive test in human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb).
  • Must not have previously participated in a study involving LY2603618
  • Must not have previously taken pemetrexed for cancer
  • Must not have a known allergy to LY2603618 or pemetrexed
  • Must not currently have an infection that may affect patient's ability to tolerate the therapy
  • Must not have a serious medical condition or disorder that would make it unsafe for you to participate in the study such as uncontrolled diabetes or chest pain due to heart disease
  • If taking certain medications called non-steroidal anti-inflammatory drugs (NSAIDS), such as ibuprofen, must be able to stop taking these medications according to certain guidelines
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00988858

Locations
United States, Arizona
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tuscon, Arizona, United States, 85704
United States, Colorado
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Denver, Colorado, United States, 80218
United States, Florida
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tampa, Florida, United States, 33612
United States, Ohio
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kettering, Ohio, United States, 45409
United States, Oregon
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Portland, Oregon, United States, 97213
United States, Texas
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Dallas, Texas, United States, 75201
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
The Woodlands, Texas, United States, 77380
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tyler, Texas, United States, 75702
United States, Washington
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Yakima, Washington, United States, 98902
Italy
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Orbassano, Italy, 10043
Korea, Republic of
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Seoul, Korea, Republic of, 138-736
Taiwan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Taichung, Taiwan, 407
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tainan, Taiwan, 70403
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00988858     History of Changes
Other Study ID Numbers: 12092, I2I-MC-JMMD
Study First Received: September 30, 2009
Last Updated: April 22, 2014
Health Authority: United States: Food and Drug Administration
Italy: The Italian Medicines Agency
Korea: Food and Drug Administration
Korea: Ministry for Health, Welfare and Family Affairs
Taiwan: Department of Health
Taiwan: Institutional Review Board
Taiwan: Center for Drug Evaluation

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pemetrexed
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on July 22, 2014