Non-small Cell Lung CancerPhase 2NCT00191191

To Investigate Efficacy and Safety of Pemetrexed as Second or Third Line Therapy in Patients With Non-small Cell Lung Cancer (NSCLC)

A Phase 2 study testing Pemetrexed 500 mg/m2 and Pemetrexed 1000 mg/m2 in people with Non-small Cell Lung Cancer, run by Eli Lilly and Company at 16 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To investigate efficacy and safety of pemetrexed as second or third line therapy in patients with non-small cell lung cancer (NSCLC). Read more about this study

Who is it for?: Ages 20 to 75 years
Conditions the study is for: Non-small Cell Lung Cancer
What is being tested?: Pemetrexed 500 mg/m2 and Pemetrexed 1000 mg/m2
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 226 participants
Where: 16 sitesJapan
Study dates: Oct 2004to Oct 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Clinical stage III or IV
Previously treated with one or two chemotherapeutic regimens
Performance status: 0-2

Who cannot join

Inability or unwillingness to take folic acid or vitamin B12 supplementation

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

Japan16 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Chiba
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Ehime
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Fukuoka
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Gifu
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Gunma
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Hokkaido
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Hyōgo
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Kanagawa
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Kumamoto
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Miyagi
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Niigata
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Okayama
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Osaka
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Saitama
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Shizuoka
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Tokyo

Other trials in Japan

About this study

Official title: LY231514 500 mg/m2 and LY231514 1000 mg/m2 in Patients With Advanced Non-Small Cell Lung Cancer Who Were Previously Treated With Prior Systemic Anti Cancer Therapy: A Randomized Phase II Trial

To investigate efficacy and safety of pemetrexed as second or third line therapy in patients with non-small cell lung cancer (NSCLC).

Conditions: Non-small Cell Lung Cancer
Being tested: Pemetrexed 500 mg/m2, Pemetrexed 1000 mg/m2
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pemetrexed 500 mg/m2Drug
Also called Alimta, LY231514
500 mg/m2, intravenous (IV), every 21 days, one year from registration date
Pemetrexed 1000 mg/m2Drug
Also called Alimta, LY231514
1000 mg/m2, intravenous (IV), every 21 days, one year from registration date

Study groups in NCT00191191
Study group	Role	What they receive
Pemetrexed 500 mg/m2	Experimental	Pemetrexed 500 mg/m2 Receives: Drug: Pemetrexed 500 mg/m2
Pemetrexed 1000 mg/m2	Experimental	Pemetrexed 1000 mg/m2 Receives: Drug: Pemetrexed 1000 mg/m2

What is being measured

The primary outcome is the main question the study is designed to answer.

Best Overall Response
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria as determined by the Case Judgment Committee. Best overall response was defined as the most favorable overall response recorded for each patient during the observation period. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
Measured: baseline to measured progressive disease (up to 3.2 years)

Secondary outcomes (4)

Duration of Response
The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression.
Measured: time of response to progressive disease (up to 3.2 years)
Progression-Free Survival (PFS)
PFS was defined as time from the scheduled date of the first treatment cycle until the date of confirmation of progressive disease on the overall response rating. For patients who died before confirmation of progressive disease, the number of days until the date of death (from any cause) was handled as progression-free survival.
Measured: baseline to measured progressive disease (up to 3.2 years)
Change From Baseline to 3 Months in Quality of Life Questionnaire for Cancer Patients Treated With Anticancer Drugs (QOL-ACD)
20-items assessed quality of life in patients undergoing chemotherapy. Scores range from 1 (not at all/very poor) to 5 (very much/very well). Face scale scores (patient circles number of the face that best fits his/her feelings) range from 1 (sad face) to 5 (smiling face). Item scores were grouped according to Functional (daily activity: 5 items), Physical (5 items), Emotional (psychological condition: 4 items), Social Attitude (5 items), and Face Scale (1 item). Score of subscales were converted to scores with range from 0 to 100. Higher scores represent higher QOL.
Measured: Baseline (pre-dose), 3 Months after first dose of Cycle 1
Change From Baseline to 3 Months in Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) Lung Cancer Subscale (LCS)
FACT-L LCS measured health-related quality of life (HR-QL) related to additional concerns of lung cancer. Original LCS subscale scores range from 0 to 28, but the scores were converted to scores with a range of 0 to 100 in this study. Higher scores represent better HR-QL.
Measured: Baseline (pre-dose), 3 Months after first dose of Cycle 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2004Oct 2008

First posted19 Sep 2005 (estimated)
Study startOct 2004
Primary completionOct 2008
Study completionOct 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 226 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00191191
Sponsor's protocol ID: 5250
Other IDs: H3E-JE-NS01
Status last verified: Dec 2009
First submitted: 12 Sep 2005
Last updated: 9 Dec 2009
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Non-small Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: LY231514 500 mg/m2 and LY231514 1000 mg/m2 in Patients With Advanced Non-Small Cell Lung Cancer Who Were Previously Treated With Prior Systemic Anti Cancer Therapy: A Randomized Phase II Trial
ClinicalTrials.gov ID: NCT00191191
Acronym / sponsor ID: 5250
Conditions: Non-small Cell Lung Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 226 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Oct 2004
Primary completion: Oct 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 19 Sep 2005 (estimated)
Results: Posted 25 Nov 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To investigate efficacy and safety of pemetrexed as second or third line therapy in patients with non-small cell lung cancer (NSCLC).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Pemetrexed 500 mg/m2	Experimental	Drug: Pemetrexed 500 mg/m2Pemetrexed 500 mg/m2
Pemetrexed 1000 mg/m2	Experimental	Drug: Pemetrexed 1000 mg/m2Pemetrexed 1000 mg/m2

Who may qualify

Ages: 20 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Clinical stage III or IV
Previously treated with one or two chemotherapeutic regimens
Performance status: 0-2

Key exclusion criteria (1 listed)

Inability or unwillingness to take folic acid or vitamin B12 supplementation

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pemetrexed 500 mg/m2Also: Alimta, LY231514500 mg/m2, intravenous (IV), every 21 days, one year from registration date	Drug	Pemetrexed 500 mg/m2
Pemetrexed 1000 mg/m2Also: Alimta, LY2315141000 mg/m2, intravenous (IV), every 21 days, one year from registration date	Drug	Pemetrexed 1000 mg/m2

Primary outcome

Best Overall Response
Time frame: baseline to measured progressive disease (up to 3.2 years)
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria as determined by the Case Judgment Committee. Best overall response was defined as the most favorable overall response recorded for each patient during the observation period. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.

4 secondary outcomes

Duration of Response
Time frame: time of response to progressive disease (up to 3.2 years)
Progression-Free Survival (PFS)
Time frame: baseline to measured progressive disease (up to 3.2 years)
Change From Baseline to 3 Months in Quality of Life Questionnaire for Cancer Patients Treated With Anticancer Drugs (QOL-ACD)
Time frame: Baseline (pre-dose), 3 Months after first dose of Cycle 1
Change From Baseline to 3 Months in Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) Lung Cancer Subscale (LCS)
Time frame: Baseline (pre-dose), 3 Months after first dose of Cycle 1

Results and safety

Results posted to the registry on 25 Nov 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pemetrexed 500 mg/m2	114	0
Pemetrexed 1000 mg/m2	112	0

Primary outcome: Best Overall Response

Time frame: baseline to measured progressive disease (up to 3.2 years). Number. Unit: participants

Measure	Pemetrexed 500 mg/m2 n = 108	Pemetrexed 1000 mg/m2 n = 108
Complete Response (CR)	0	0
Partial Response (PR)	20	16
Stable Disease (SD)	40	34
Progressive Disease (PD)	48	58

Population analysed: Full analysis set: all randomized participants who met all of the inclusion criteria and none of the exclusion criteria and received at least one dose of study drug.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pemetrexed 500 mg/m2	19 of 114 (16.7%)	114 of 114 (100%)	Not reported
Pemetrexed 1000 mg/m2	21 of 111 (18.9%)	111 of 111 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Lilly Clinical Trial RegistryLink provided by the sponsor.

Related trials for Non-small Cell Lung Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time(UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pemetrexed 500 mg/m2 and Pemetrexed 1000 mg/m2 in people with Non-small Cell Lung Cancer, run by Eli Lilly and Company at 16 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Nov 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best Overall Response (time frame: baseline to measured progressive disease (up to 3.2 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00191191.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2009.