Lung NeoplasmsNCT00497770

An Observational Study of the Ethnic Impact of Patients Undergoing Second (2nd) Line Treatment for Non-Small Cell Lung Cancer Using Pemetrexed

An observational study of Lung Neoplasms, run by Eli Lilly and Company at 38 sites in 2 countries.

Completed

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

Trial summary

This large, non-randomized observational study is being conducted to provide data about the impact of ethnic origin on outcomes and resource utilization during the 2nd line treatment of non-small cell lung cancer (NSCLC) in a routine medical care setting. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Neoplasms
What is being tested?: Pemetrexed
How many people: 434 participants
Where: 38 sitesin 2 countries
Study dates: Feb 2007to Mar 2011
Phase: Observational
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients receiving pemetrexed for second (2nd) line treatment of non-small cell lung cancer (NSCLC): 400 Caucasians, 200 African-Americans, 200 Asian-Americans, and 200 Hispanic patients will be accrued to this study.

Who may be able to join

Non-small cell lung cancer (NSCLC) (any histologic type)
Stage IIIB or IV disease
Should have had 1 line of chemotherapy for Metastatic disease
Adequate hematologic, hepatic and renal function
Measurable or evaluable disease

Who cannot join

Pregnant or lactating females

Trial locations and contacts

38 sites in 2 countries.

Country

City, postcode or hospital

38 sites in 2 countries

United States37 sites

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.
Anaheim, California, 92801
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Buffalo, New York, 14263
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Campbell, California, 95008
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Corpus Christi, Texas, 78463
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Daly City, California, 94015
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Decatur, Georgia, 30033
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Denver, Colorado, 80209
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Fort Lauderdale, Florida, 33308
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Galveston, Texas, 77555
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Glendale, Arizona, 85304
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Greeley, Colorado, 80631
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Honolulu, Hawaii, 96813
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Kealakekua, Hawaii, 96750
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La Jolla, California, 92093
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Lancaster, California, 93534
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Las Vegas, Nevada, 89109
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Memphis, Tennessee, 38138
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Miami, Florida, 33179
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Mission Hills, California, 91345
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Mobile, Alabama, 36608
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Monroe, Washington, 98272
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Morehead, Kentucky, 40351
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Nashville, Tennessee, 37203
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New Orleans, Louisiana, 70121
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Omaha, Nebraska, 68131
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Palo Alto, California, 94305
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Poway, California, 92064
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Richardson, Texas, 75080
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San Diego, California, 92123
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San Francisco, California, 94115
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San Jose, California, 95116
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Santa Cruz, California, 95065
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Seattle, Washington, 98133
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Stamford, Connecticut, 06902
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Sunnyvale, California, 94088
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Washington, North Carolina, 27889
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Weston, Florida, 33331

Other trials in United States

Puerto Rico1 site

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San Juan, 00918

Other trials in Puerto Rico

About this study

Official title: Non-small Cell Lung Cancer: The Impact of Ethnic Origin on Patients Being Treated Second Line With Pemetrexed - An Observational Study

Read the detailed description

This is a large 1000 patient single arm observational study being conducted to determine the impact of ethnic origin (Caucasian, African-Americans, Asian-Americans, and Hispanics) on patients being treated for 2nd line advanced NSCLC with pemetrexed given in routine clinical practice. Data will be collected on disease control rate by pemetrexed as defined by Response Rate (RR) (Complete Response (CR) + Partial Response (PR)), Stable Disease (SD) and toxicities. In addition, overall survival, progression-free survival, treatment toxicities, activities of daily living, symptom burden and resource utilization will also be observed. To meet the study goals, a total of 400 Caucasians, 200 African- Americans, 200 Asian-Americans, and 200 Hispanics will be accrued to this study.

Conditions: Lung Neoplasms
Being tested: Pemetrexed
Medical subject headings: Lung Neoplasms

What participants receive

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

PemetrexedDrug
Also called LY231514, Alimta
Treatment pattern and treatment initiation or changes are solely at the discretion of the physician and the patient

Study groups in NCT00497770
Study group	Role	What they receive
Caucasian		Caucasian patients receiving Alimta for 2nd line NSCLC Receives: Drug: Pemetrexed
African American		African American patients receiving Alimta for 2nd line NSCLC Receives: Drug: Pemetrexed
Asian American		Asian American patients receiving Alimta for 2nd line NSCLC Receives: Drug: Pemetrexed
Hispanic		Hispanic patients receiving Alimta for 2nd line NSCLC Receives: Drug: Pemetrexed

What is being measured

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

Percentage of Participants With a Best Overall Disease Control Response (Disease Control Rate)
Disease Control Rate [DCR] is the percentage of participants with Complete Response (CR), Partial Response (PR), Stable Disease (SD), and SD or Incomplete Response (SI). Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; SD=small changes not meeting above criteria; SI=persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker level above normal limits.
Measured: baseline to measured progressive disease (up to 20 cycles [14 months])

Secondary outcomes (10)

Overall Survival
Overall survival is the duration (months) from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
Measured: baseline to date of death from any cause (up to 20 cycles [14 months])
Progression Free Survival
Time from start of second line therapy until death, disease progression, or last contact expressed in months. Participants lost to follow-up (that were alive at last contact) were treated as censored using Kaplan-Meier survival analysis method.
Measured: baseline to measured progressive disease or death (up to 20 cycles [14 months])
Functional Status Based on Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Plan and Prepare Meals
The daily activities assessed: ability to plan and prepare meals. OARS-IADL assesses the participant's ability to plan and prepare meals at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.
Measured: beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Drive or Use Public Transportation
The daily activities assessed: ability to drive or use public transportation. OARS-IADL assesses the participant's ability to drive or use public transportation at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.
Measured: beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Handle Personal Finances
The daily activities assessed: ability to handle personal finances. OARS-IADL assesses the participant's ability to handle personal finances at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.
Measured: beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Perform Housework Activities
The daily activities assessed: ability to perform housework activities. OARS-IADL assesses the participant's ability to perform housework activities at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.
Measured: beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Prepare and Take Medications
The daily activities assessed: ability to prepare and take medications. OARS-IADL assesses the participant's ability to prepare and take medications at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.
Measured: beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to do the Act of Shopping
The daily activities assessed: ability to do the act of shopping. OARS-IADL assesses the participant's ability to do the act of shopping at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.
Measured: beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Operate the Telephone
The daily activities assessed: ability to operate the telephone. OARS-IADL assesses the participant's ability to operate the telephone at baseline and end of treatment. Responses: ability to do the activity without help, some help, unable, or not done (missing). The percent of participants responding in the different levels of functional ability are provided.
Measured: beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
The symptom score assessed: pain, fatigue, nausea, sleep, distress, shortness of breath, memory, appetite, drowsy, dry mouth, sadness, vomiting, numbness, cough, constipation, general activity, mood, work, relationships with other people, walking, enjoyment. Scores for each item range from 0 to 10, where 0 equaled no symptoms and 10 equaled worst possible symptoms. Assessed at baseline and end of treatment.
Measured: Baseline and end of treatment (up to 20 cycles [14 months])

Timeline

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

Feb 2007Mar 2011

First posted9 Jul 2007 (estimated)
Study startFeb 2007
Primary completionMar 2011
Study completionMar 2011

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 Lung NeoplasmsStudies 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: Observational
Time perspective: Prospective
Enrolment: 434 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00497770
Sponsor's protocol ID: 10733
Other IDs: H3E-US-B001
Status last verified: Apr 2012
First submitted: 5 Jul 2007
Last updated: 2 May 2012
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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Study at a glance

From the registry record, last updated by the sponsor on 2 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-small Cell Lung Cancer: The Impact of Ethnic Origin on Patients Being Treated Second Line With Pemetrexed - An Observational Study
ClinicalTrials.gov ID: NCT00497770
Acronym / sponsor ID: 10733
Conditions: Lung Neoplasms
Study type: Observational
Recruitment status: Completed
Enrolment: 434 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Feb 2007
Primary completion: Mar 2011 (actual)
Study completion: Mar 2011 (actual)
First posted: 9 Jul 2007 (estimated)
Results: Posted 11 Apr 2012

Clinical summary

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

Detailed description

Study design

Time perspective: Prospective
Number of arms: 4

Arm	Type	Receives
Caucasian	–	Drug: PemetrexedCaucasian patients receiving Alimta for 2nd line NSCLC
African American	–	Drug: PemetrexedAfrican American patients receiving Alimta for 2nd line NSCLC
Asian American	–	Drug: PemetrexedAsian American patients receiving Alimta for 2nd line NSCLC
Hispanic	–	Drug: PemetrexedHispanic patients receiving Alimta for 2nd line NSCLC

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients receiving pemetrexed for second (2nd) line treatment of non-small cell lung cancer (NSCLC): 400 Caucasians, 200 African-Americans, 200 Asian-Americans, and 200 Hispanic patients will be accrued to this study.

Key inclusion criteria (5 listed)

Non-small cell lung cancer (NSCLC) (any histologic type)
Stage IIIB or IV disease
Should have had 1 line of chemotherapy for Metastatic disease
Adequate hematologic, hepatic and renal function
Measurable or evaluable disease

Key exclusion criteria (1 listed)

Pregnant or lactating females

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
PemetrexedAlso: LY231514, AlimtaTreatment pattern and treatment initiation or changes are solely at the discretion of the physician and the patient	Drug	African American, Asian American, Caucasian, Hispanic

Primary outcome

Percentage of Participants With a Best Overall Disease Control Response (Disease Control Rate)
Time frame: baseline to measured progressive disease (up to 20 cycles [14 months])
Disease Control Rate [DCR] is the percentage of participants with Complete Response (CR), Partial Response (PR), Stable Disease (SD), and SD or Incomplete Response (SI). Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; SD=small changes not meeting above criteria; SI=persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker level above normal limits.

10 secondary outcomes

Overall Survival
Time frame: baseline to date of death from any cause (up to 20 cycles [14 months])
Progression Free Survival
Time frame: baseline to measured progressive disease or death (up to 20 cycles [14 months])
Functional Status Based on Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Plan and Prepare Meals
Time frame: beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Drive or Use Public Transportation
Time frame: beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Handle Personal Finances
Time frame: beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Perform Housework Activities
Time frame: beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Prepare and Take Medications
Time frame: beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to do the Act of Shopping
Time frame: beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])
Functional Status Based on the Older Americans Resources and Services Instrumental Activities of Daily Living Scale(OARS-IADL), Ability to Operate the Telephone
Time frame: beginning and at end of pemetrexed treatment (up to 20 cycles [14 months])
Symptom Score Associated With Treatment as Measured by the M.D. Anderson Symptom Inventory - LC(MDASI-LC)
Time frame: Baseline and end of treatment (up to 20 cycles [14 months])

Results and safety

Results posted to the registry on 11 Apr 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Caucasian	304	304
African American	65	65
Asian American	37	37
Hispanic	28	28

Primary outcome: Percentage of Participants With a Best Overall Disease Control Response (Disease Control Rate)

Time frame: baseline to measured progressive disease (up to 20 cycles [14 months]). Number. Unit: percentage of participants

Measure	Caucasian n = 268	African American n = 60	Asian American n = 30	Hispanic n = 26
Value	43.7	45.0	53.33	34.6

Caucasian vs African American: Odds Ratio (OR): 0.821 (95% CI 0.427 to 1.580), Regression, Logistic

Population analysed: Of the 434 participants enrolled, 50 participants had a response status at the end of pemetrexed treatment indicating "Not done/Missing" and were not included in this analysis.

10 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
Caucasian	21 of 304 (6.9%)	256 of 304 (84.2%)	Not reported
African American	4 of 65 (6.2%)	54 of 65 (83.1%)	Not reported
Asian American	1 of 37 (2.7%)	27 of 37 (73%)	Not reported
Hispanic	1 of 28 (3.6%)	21 of 28 (75%)	Not reported

Limitations and caveats (from the sponsor): This is an observational study, as such, the investigators followed the label recommendations and any changes to the label which occurred during the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Lilly Clinical Trial RegistryLink provided by the sponsor.

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Breast Cancer, Comorbidities and Coexisting Conditions
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

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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

38 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Neoplasms, run by Eli Lilly and Company at 38 sites in 2 countries.

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 5 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 2 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, Puerto Rico. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Apr 2012). 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?

Percentage of Participants With a Best Overall Disease Control Response (Disease Control Rate) (time frame: baseline to measured progressive disease (up to 20 cycles [14 months])). 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 NCT00497770.

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 2 May 2012.