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A Study Comparing of Two Different Chemotherapy Regimens, in Patients With Advanced 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
Best Supportive Care
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  1. You must be at least 18 years old
  2. You must have been diagnosed with non-squamous non-small cell lung cancer (NSCLC)
  3. You must have had no prior systemic anticancer therapy for lung cancer
  4. You must live close enough to the study doctor to be able to visit regularly for follow up
  5. You must have signed informed consent form indicating your willingness to take part in this study
  6. Your laboratory and medical history and tests must meet study requirements

Exclusion criteria:

  1. Treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
  2. Prior radiotherapy and surgery should be completed at least 4 weeks prior to initiation of treatment
  3. Serious concomitant systemic disorder (e.g., active infection including human immunodeficiency virus, or unstable cardiovascular disease)
  4. Prior malignancy other than NSCLC, carcinoma in situ of the cervix, or nonmelanoma skin cancer unless treated at least 5 years previously with no subsequent evidence of recurrence
  5. Brain metastasis
  6. Presence of clinically significant (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry
  7. Significant weight loss (greater than 10%), over the previous 6 weeks before study entry
  8. Concurrent administration of any other antitumor therapy
  9. Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents such as piroxicam)
  10. Inability or unwillingness to take folic acid, dexamethasone (or equivalent) or vitamin B12 supplementation
  11. Pregnancy or breast-feeding
  12. You are allergic to pemetrexed

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A: Pemetrexed + Best Supportive Care

B: Best Supportive Care

Arm Description

Pemetrexed: 500 milligrams per square meter (mg/m²) , intravenous (IV), Day 1 of each 21-day cycle for 6 cycles Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.

Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.

Outcomes

Primary Outcome Measures

Progression Free Survival During Maintenance Phase
Progression free survival is defined as the time from randomization until the date of progression of disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is ≥20% increase in sum of longest diameter of target lesions. PD in maintenance phase uses the last lesion assessment prior to randomization as the baseline assessment.

Secondary Outcome Measures

Progression Free Survival During Overall Period (Induction Phase [IP] + Maintenance Phase [MP])
Progression-free survival in overall period is defined as the time from the date of first dose of study drug during IP until the date of PD or death from any cause. PD was determined using RECIST criteria. PD is ≥20% increase in sum of longest diameter of target lesions. PD in overall period uses the screening lesion assessment prior to the induction phase as the baseline assessment.
Overall Survival During Maintenance Phase
Overall survival in maintenance phase is defined as the time from randomization to death. Participants who were alive were censored at the last contact.
Overall Survival During Overall Period (IP + MP)
Overall survival in overall period is defined as the time from first dose of study drug during IP to death. Participants who were alive were censored at the last contact.
Number of Participants With Adverse Events (AEs) During Overall Period
The list of serious adverse events (SAEs) and other non-serious adverse events (AEs) are in Adverse Events Section.
Tumor Response Rate and Disease Control Rate After Induction Phase (IP)
Tumor response rate (%) is the number of responders (participants with best response of CR or PR) divided by the number of participants qualified for tumor response according to RECIST criteria multiplied by 100. Disease control rate is percentage of participants with a best response of stable disease [SD], PR, or CR. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; PD is≥20% increase in sum of longest diameter of target lesions. SD= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

Full Information

First Posted
January 17, 2008
Last Updated
November 21, 2011
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00606021
Brief Title
A Study Comparing of Two Different Chemotherapy Regimens, in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
Official Title
A Randomized Phase 2 Study Comparing Pemetrexed Plus Best Supportive Care With Best Supportive Care as Maintenance, Following First-Line Treatment With Pemetrexed-Cisplatin, in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

5. Study Description

Brief Summary
This is a multicenter, open-label, randomized, two-arm Phase 2 study comparing pemetrexed plus best supportive care with best supportive care alone as maintenance therapy following first-line treatment with a pemetrexed-cisplatin combination in patients with advanced non-squamous non-small cell lung cancer. A total of approximately 100 patients are planned to be enrolled, and following completion of four cycles of pemetrexed-cisplatin (Induction Phase) those patients in which disease progression has not occurred will be randomized in a 2:1 ratio to one of two treatment arms (Maintenance Phase): Arm A (pemetrexed plus best supportive care) or Arm B (best supportive care alone).

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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A: Pemetrexed + Best Supportive Care
Arm Type
Experimental
Arm Description
Pemetrexed: 500 milligrams per square meter (mg/m²) , intravenous (IV), Day 1 of each 21-day cycle for 6 cycles Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
Arm Title
B: Best Supportive Care
Arm Type
Active Comparator
Arm Description
Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
Intervention Type
Drug
Intervention Name(s)
pemetrexed
Other Intervention Name(s)
Alimta, LY231514
Intervention Description
500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles
Intervention Type
Drug
Intervention Name(s)
Best Supportive Care
Intervention Description
Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
Primary Outcome Measure Information:
Title
Progression Free Survival During Maintenance Phase
Description
Progression free survival is defined as the time from randomization until the date of progression of disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is ≥20% increase in sum of longest diameter of target lesions. PD in maintenance phase uses the last lesion assessment prior to randomization as the baseline assessment.
Time Frame
Randomization to progression of disease (PD) or date of death from any cause up to 30.9 months
Secondary Outcome Measure Information:
Title
Progression Free Survival During Overall Period (Induction Phase [IP] + Maintenance Phase [MP])
Description
Progression-free survival in overall period is defined as the time from the date of first dose of study drug during IP until the date of PD or death from any cause. PD was determined using RECIST criteria. PD is ≥20% increase in sum of longest diameter of target lesions. PD in overall period uses the screening lesion assessment prior to the induction phase as the baseline assessment.
Time Frame
First dose of study drug during IP to PD or date of death from any cause up to 33.6 months
Title
Overall Survival During Maintenance Phase
Description
Overall survival in maintenance phase is defined as the time from randomization to death. Participants who were alive were censored at the last contact.
Time Frame
Randomization to PD or date of death from any cause up to 31.3 months
Title
Overall Survival During Overall Period (IP + MP)
Description
Overall survival in overall period is defined as the time from first dose of study drug during IP to death. Participants who were alive were censored at the last contact.
Time Frame
First dose of study drug during IP to PD or date of death from any cause up to 34.1 months
Title
Number of Participants With Adverse Events (AEs) During Overall Period
Description
The list of serious adverse events (SAEs) and other non-serious adverse events (AEs) are in Adverse Events Section.
Time Frame
First dose of study drug during IP through overall study completion (up to 34.3) months
Title
Tumor Response Rate and Disease Control Rate After Induction Phase (IP)
Description
Tumor response rate (%) is the number of responders (participants with best response of CR or PR) divided by the number of participants qualified for tumor response according to RECIST criteria multiplied by 100. Disease control rate is percentage of participants with a best response of stable disease [SD], PR, or CR. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; PD is≥20% increase in sum of longest diameter of target lesions. SD= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Time Frame
Randomization to measured PD up to 31.4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: You must be at least 18 years old You must have been diagnosed with non-squamous non-small cell lung cancer (NSCLC) You must have had no prior systemic anticancer therapy for lung cancer You must live close enough to the study doctor to be able to visit regularly for follow up You must have signed informed consent form indicating your willingness to take part in this study Your laboratory and medical history and tests must meet study requirements Exclusion criteria: Treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry Prior radiotherapy and surgery should be completed at least 4 weeks prior to initiation of treatment Serious concomitant systemic disorder (e.g., active infection including human immunodeficiency virus, or unstable cardiovascular disease) Prior malignancy other than NSCLC, carcinoma in situ of the cervix, or nonmelanoma skin cancer unless treated at least 5 years previously with no subsequent evidence of recurrence Brain metastasis Presence of clinically significant (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry Significant weight loss (greater than 10%), over the previous 6 weeks before study entry Concurrent administration of any other antitumor therapy Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents such as piroxicam) Inability or unwillingness to take folic acid, dexamethasone (or equivalent) or vitamin B12 supplementation Pregnancy or breast-feeding You are allergic to pemetrexed
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 9am to 5pm 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
Assiut
ZIP/Postal Code
0000
Country
Egypt
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
Cairo
ZIP/Postal Code
11372
Country
Egypt
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
Mounofia
ZIP/Postal Code
32514
Country
Egypt
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
Beirut
Country
Lebanon
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
Riyadh
ZIP/Postal Code
11211
Country
Saudi Arabia

12. IPD Sharing Statement

Citations:
PubMed Identifier
23006447
Citation
Mubarak N, Gaafar R, Shehata S, Hashem T, Abigeres D, Azim HA, El-Husseiny G, Al-Husaini H, Liu Z. A randomized, phase 2 study comparing pemetrexed plus best supportive care versus best supportive care as maintenance therapy after first-line treatment with pemetrexed and cisplatin for advanced, non-squamous, non-small cell lung cancer. BMC Cancer. 2012 Sep 24;12:423. doi: 10.1186/1471-2407-12-423.
Results Reference
derived

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A Study Comparing of Two Different Chemotherapy Regimens, in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer

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