Brief Summary

The primary purpose of this study is to evaluate the efficacy and 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 participants with advanced or metastatic Non-small Cell Lung Cancer (NSCLC).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Nov 2009

Longer than P75 for phase_2

Geographic Reach

4 countries

13 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5 years study duration

First Submitted

Initial submission to the registry

September 30, 2009

Completed

2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2009

Completed

1 month until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed

2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed

2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed

2.8 years until next milestone

Results Posted

Study results publicly available

August 15, 2017

Completed

Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

2.7 years

First QC Date

September 30, 2009

Results QC Date

July 14, 2017

Last Update Submit

September 9, 2019

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

Overall Tumor Response - Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]
Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of not-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.
Baseline until Progressive Disease or Study Discontinuation (Up to 23 Months)

Secondary Outcomes (8)

Percentage of Participants Who Achieved a Best Response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Clinical Benefit Rate)
Baseline until Progressive Disease or Study Discontinuation (Up to 23 Months)
Progression-free Survival (PFS)
Baseline to Progressive Disease or Death Due to Any Cause (Up to 27.1 Months)
Duration of Response
First Observation of CR or PR until Progressive Disease or Death Due to Any Cause (Up to 23 Months)
Change in Symptom Burden Scores of Lung Cancer Symptom Scale (LCSS)
Baseline until End of Study (Up to 27.1 Months)
Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2603618
Day 2 and Day 3 of Cycle 1 and Cycle 2: Prior to End of Infusion (EOI); EOI + 1-2 hr; EOI + 4-6 hr; EOI + 20-28 hr; anytime on Day 8 of Cycle 1 and Cycle 2
+3 more secondary outcomes

Study Arms (1)

LY2603618 and Pemetrexed

EXPERIMENTAL

Drug: LY2603618Drug: Pemetrexed

Interventions

LY2603618DRUG

150 milligram per square meter (mg/m\^2) intravenously on Day 2 of each 21 day cycle repeating every 21 days for a minimum of 2 cycles continuing until disease progression

LY2603618 and Pemetrexed

PemetrexedDRUG

500 mg/m\^2 intravenously on Day 1 of each 21 Day cycle repeating every 21 days for a minimum of 2 cycles or until disease progression

Also known as: Alimta, LY231514

LY2603618 and Pemetrexed

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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 participant'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 participant'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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (13)

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.

Tucson, Arizona, 85704, United States

Location

Denver, Colorado, 80218, United States

Location

Tampa, Florida, 33612, United States

Location

Kettering, Ohio, 45409, United States

Location

Portland, Oregon, 97213, United States

Location

Dallas, Texas, 75201, United States

Location

The Woodlands, Texas, 77380, United States

Location

Tyler, Texas, 75702, United States

Location

Yakima, Washington, 98902, United States

Location

Orbassano, 10043, Italy

Location

Seoul, 138-736, South Korea

Location

Taichung, 407, Taiwan

Location

Tainan, 70403, Taiwan

Location

Related Publications (1)

Scagliotti G, Kang JH, Smith D, Rosenberg R, Park K, Kim SW, Su WC, Boyd TE, Richards DA, Novello S, Hynes SM, Myrand SP, Lin J, Smyth EN, Wijayawardana S, Lin AB, Pinder-Schenck M. Phase II evaluation of LY2603618, a first-generation CHK1 inhibitor, in combination with pemetrexed in patients with advanced or metastatic non-small cell lung cancer. Invest New Drugs. 2016 Oct;34(5):625-35. doi: 10.1007/s10637-016-0368-1. Epub 2016 Jun 27.
PMID: 27350064DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

LY2603618Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Dicarboxylic

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

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
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 30, 2009

First Posted

October 2, 2009

Study Start

November 1, 2009

Primary Completion

July 1, 2012

Study Completion

November 1, 2014

Last Updated

September 17, 2019

Results First Posted

August 15, 2017

Record last verified: 2019-09

Data Sharing

IPD Sharing: Will share
Shared Documents: STUDY PROTOCOL, SAP, CSR
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

TW(2)IT(1)US(9)KR(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (1)

LY2603618 and Pemetrexed

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (13)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations