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A Study of Induction and Maintenance Treatment of Advanced or Metastatic Non Squamous Non-Small Cell Lung Cancer

Primary Purpose

Non-Small-Cell Lung Cancer

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Pemetrexed

Cisplatin

Cetuximab

About this trial

This is an interventional treatment trial for Non-Small-Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient must sign an informed consent document for clinical and translational research.
Patient must have locally advanced or metastatic nonsquamous Non-Small Cell Lung Cancer.
Patient must have biological tissue available from your diagnosis tumor for detection of some biomarkers (translational research).
Patient cannot be receiving nor have received any prior systemic anticancer therapy, immunotherapy, targeted therapy, or biological therapy for your lung cancer (except chemotherapy given after surgery if it has been completed more than one year before the study entry).
Patient is allowed to have had prior radiation therapy as long as it was not more than 25% of the bone marrow and did not include the whole pelvis. Prior radiation therapy should be completed at least 2 weeks prior to first study drug. Thoracic radiation must be completed more than 12 weeks before the study entry. You must be recovered from the toxic effects.
Patient must have at least 1 measurable tumor lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.
Patient must at least be able to be physically mobile, take care of yourself, and must be up and about and able to perform light activities such as light housework or office work.
Test results assessing the function of blood forming tissue, kidneys, and liver must be satisfactory.
Females must be sterile, postmenopausal or on contraception.
Males must be on contraception or sterile (for example post-vasectomy).

Exclusion Criteria:

Patient cannot have symptomatic central nervous system metastases.
Patient cannot have an active infection or other serious condition that your doctor thinks would make you unable to participate.
Patient cannot have a serious cardiac condition, such as a heart attack, angina, or heart disease within 6 months of entering the trial.
Patient cannot have had a another form of cancer other than superficial basal cell and superficial squamous (skin) cell cancer, or carcinoma in situ of the cervix within the last 5 years.
Patient cannot have had significant neurologic or psychiatric disorders including dementia, seizures and bipolar disorder.
Patient cannot have moderate or severe peripheral neuropathy
Patient cannot have received treatment within 30 days with any experimental drug.
Patient cannot have had a major surgery within the last 4 weeks.
Patient cannot have previously received treatment with transduction inhibitors or Epidermal Growth Factor Receptor (EGFR)-targeting therapy.
Patient cannot have prior known allergic/hypersensitivity reaction to any of the components of study treatments.
Females cannot be pregnant or breastfeeding.
Patient is unable to stop taking more than 1.3 grams of aspirin on a daily basis or other aspirin like medication (non-steroidal antiinflammatory drugs: NSAIDs) for a few days during each cycle of therapy.
Patient is unable or unwilling to take folic acid, injections of vitamin B12, or corticosteroids.
Patient cannot have fluid around your lungs or in your abdomen (pleural effusions or ascites) that cannot be controlled by drainage or other procedures.
Patient cannot have received a yellow fever vaccination within the previous 30 days or plan to have it.
Patient cannot have known drug abuse.

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Induction/maintenance Therapy

Arm Description

pemetrexed, cisplatin and cetuximab followed by pemetrexed and cetuximab

Outcomes

Primary Outcome Measures

Percentage of Participants With a Tumor Response (Objective Tumor Response Rate)

Response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions. Tumor response is presented as a percentage (%) and is the number of participants with a CR plus PR divided by the number of participants in the protocol qualified (PQ) population, then multiplied by 100.

Secondary Outcome Measures

Progression-free Survival (PFS)

PFS is measured from study entry until disease progression, death or date of last contact. Progressive disease (PD) was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For participants not known to have died or have had objective PD as of the data cutoff date, PFS was censored at the date of the last objective progression-free disease assessment.

The Percentage of Participants Still Living at One Year (One Year Survival Rate)

The one year survival rate is presented as percentage (%) of participants still living at one year and is the number of participants that are still alive at one year divided by the number of participants in the protocol qualified (PQ) population, which is then multiplied by 100.

The Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR])

The DCR is presented as percentage (%) and is the number of participants with a best tumor response of CR, PR, or SD divided by the number of participants in the protocol qualified (PQ) population, then multiplied by 100. Best tumor response of CR, PR, or SD was determined from the sequence of tumor response assessments. Tumor response was assessed using RECIST criteria. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; SD=small changes that do not meet above criteria.

Full Information

NCT ID

NCT00867009

First Posted

March 20, 2009

Last Updated

May 20, 2015

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00867009

Brief Title

A Study of Induction and Maintenance Treatment of Advanced or Metastatic Non Squamous Non-Small Cell Lung Cancer

Official Title

A Phase 2 Study of Pemetrexed and Cisplatin Plus Cetuximab Followed by Pemetrexed and Cetuximab Maintenance Therapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB or IV) Other Than Predominantly Squamous Cell Histology

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Completed

Study Start Date

April 2009 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study will estimate the response rate in patients with advanced or metastatic non-squamous Non-Small Cell Lung Cancer. Patients who don't progress after 4 to 6 cycles of induction treatment with pemetrexed, cisplatin and cetuximab will receive maintenance treatment with pemetrexed and cetuximab.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Small-Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

113 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Induction/maintenance Therapy

Arm Type

Experimental

Arm Description

pemetrexed, cisplatin and cetuximab followed by pemetrexed and cetuximab

Intervention Type

Drug

Intervention Name(s)

Pemetrexed

Other Intervention Name(s)

Alimta, LY231514

Intervention Description

Induction therapy: 500 mg/m², intravenous, on Day 1 of each 21-day cycle for 4 to 6 cycles Maintenance therapy: 500 mg/m², intravenous, on Day 1 of each 21-day cycle until progressive disease or treatment discontinuation

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

Induction therapy: 75 mg/m², intravenous, on Day 1 of each 21-day cycle for 4 to 6 cycles

Intervention Type

Drug

Intervention Name(s)

Cetuximab

Intervention Description

Induction therapy: Loading dose of 400 mg/m², intravenous, on Day 1 of cycle 1, then 250 mg/m², intravenous, weekly for 4 to 6 cycles, 21 day cycles Maintenance therapy: 250 mg/m², intravenous, weekly until progressive disease or treatment discontinuation

Primary Outcome Measure Information:

Title

Percentage of Participants With a Tumor Response (Objective Tumor Response Rate)

Description

Time Frame

From start of treatment until documented best response. (up to 18.9 months)

Secondary Outcome Measure Information:

Title

Progression-free Survival (PFS)

Description

Time Frame

From start of treatment until documented disease progression or death from any cause (up to 18.9 months)

Title

The Percentage of Participants Still Living at One Year (One Year Survival Rate)

Description

Time Frame

One year

Title

The Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR])

Description

Time Frame

From start of treatment until documented best tumor response (up to 18.9 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient must sign an informed consent document for clinical and translational research. Patient must have locally advanced or metastatic nonsquamous Non-Small Cell Lung Cancer. Patient must have biological tissue available from your diagnosis tumor for detection of some biomarkers (translational research). Patient cannot be receiving nor have received any prior systemic anticancer therapy, immunotherapy, targeted therapy, or biological therapy for your lung cancer (except chemotherapy given after surgery if it has been completed more than one year before the study entry). Patient is allowed to have had prior radiation therapy as long as it was not more than 25% of the bone marrow and did not include the whole pelvis. Prior radiation therapy should be completed at least 2 weeks prior to first study drug. Thoracic radiation must be completed more than 12 weeks before the study entry. You must be recovered from the toxic effects. Patient must have at least 1 measurable tumor lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Patient must at least be able to be physically mobile, take care of yourself, and must be up and about and able to perform light activities such as light housework or office work. Test results assessing the function of blood forming tissue, kidneys, and liver must be satisfactory. Females must be sterile, postmenopausal or on contraception. Males must be on contraception or sterile (for example post-vasectomy). Exclusion Criteria: Patient cannot have symptomatic central nervous system metastases. Patient cannot have an active infection or other serious condition that your doctor thinks would make you unable to participate. Patient cannot have a serious cardiac condition, such as a heart attack, angina, or heart disease within 6 months of entering the trial. Patient cannot have had a another form of cancer other than superficial basal cell and superficial squamous (skin) cell cancer, or carcinoma in situ of the cervix within the last 5 years. Patient cannot have had significant neurologic or psychiatric disorders including dementia, seizures and bipolar disorder. Patient cannot have moderate or severe peripheral neuropathy Patient cannot have received treatment within 30 days with any experimental drug. Patient cannot have had a major surgery within the last 4 weeks. Patient cannot have previously received treatment with transduction inhibitors or Epidermal Growth Factor Receptor (EGFR)-targeting therapy. Patient cannot have prior known allergic/hypersensitivity reaction to any of the components of study treatments. Females cannot be pregnant or breastfeeding. Patient is unable to stop taking more than 1.3 grams of aspirin on a daily basis or other aspirin like medication (non-steroidal antiinflammatory drugs: NSAIDs) for a few days during each cycle of therapy. Patient is unable or unwilling to take folic acid, injections of vitamin B12, or corticosteroids. Patient cannot have fluid around your lungs or in your abdomen (pleural effusions or ascites) that cannot be controlled by drainage or other procedures. Patient cannot have received a yellow fever vaccination within the previous 30 days or plan to have it. Patient cannot have known drug abuse.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

City

Wels

ZIP/Postal Code

4600

Country

Austria

Facility Name

City

Berlin

ZIP/Postal Code

13125

Country

Germany

Facility Name

City

Halle

ZIP/Postal Code

D-06120

Country

Germany

Facility Name

City

Homburg

ZIP/Postal Code

66421

Country

Germany

Facility Name

City

Mannheim

ZIP/Postal Code

68167

Country

Germany

Facility Name

City

Tuebingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

City

Athens

ZIP/Postal Code

11527

Country

Greece

Facility Name

City

Patras

ZIP/Postal Code

26500

Country

Greece

Facility Name

City

Bari

ZIP/Postal Code

70126

Country

Italy

Facility Name

City

Bergamo

ZIP/Postal Code

24128

Country

Italy

Facility Name

City

Palermo

ZIP/Postal Code

90146

Country

Italy

Facility Name

City

Potenza

ZIP/Postal Code

85028

Country

Italy

Facility Name

City

Torino

ZIP/Postal Code

10100

Country

Italy

Facility Name

City

Treviso

ZIP/Postal Code

31100

Country

Italy

Facility Name

City

Amsterdam

ZIP/Postal Code

1081 HV

Country

Netherlands

Facility Name

City

Groningen

ZIP/Postal Code

9713 GZ

Country

Netherlands

Facility Name

City

Maastricht

ZIP/Postal Code

6229 HX

Country

Netherlands

Facility Name

City

S-Hertogenbosch

ZIP/Postal Code

5211 NL

Country

Netherlands

Facility Name

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Facility Name

City

Lleida

ZIP/Postal Code

25198

Country

Spain

Facility Name

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

City

Reus

ZIP/Postal Code

43201

Country

Spain

12. IPD Sharing Statement

Learn more about this trial

A Study of Induction and Maintenance Treatment of Advanced or Metastatic Non Squamous Non-Small Cell Lung Cancer

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