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A Phase 2 Study to Evaluate LY2603618 in Combination With Pemetrexed in Patients With Advanced or Metastatic Non-small Cell Lung Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non Small Cell Lung Cancer

Thank you

Trial Information

A Phase 2 Study to Evaluate LY2603618 in Combination With Pemetrexed in Patients With Advanced or Metastatic Non-small Cell Lung Cancer


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall tumor response

Outcome Time Frame:

Baseline, near the end of cycle 2 and near the end of every other cycle thereafter until progressive disease or study discontinuation

Safety Issue:

No

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

12092

NCT ID:

NCT00988858

Start Date:

November 2009

Completion Date:

April 2014

Related Keywords:

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

Name

Location

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  
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.Phoenix, Arizona  85012
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.Jacksonville, Florida  32256
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.Cincinnati, Ohio  45267
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.Eugene, Oregon  97401
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.Bedford, Texas  76022
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.Seattle, Washington  98133