Lung NeoplasmsPhase 2NCT00356525

Chemotherapy Treatment in Re-occurring Non Small Cell Lung Cancer (NSCLC) After Previous Chemotherapy and Surgical Removal of the NSCLC Tumor

A Phase 2 study testing pemetrexed, gemcitabine and carboplatin in people with Lung Neoplasms, run by Eli Lilly and Company at 17 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to help answer: Whether pemetrexed, gemcitabine and/or carboplatin can shrink tumor(s) or make tumor(s) disappear in patients with relapsed lung cancer (lung cancer that has come back after surgical removal and chemotherapy), and to determine how long this will last Whether pemetrexed… 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, gemcitabine and carboplatin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 17 sitesin 3 countries
Study dates: Sep 2006to Apr 2009
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

You have non-small cell lung cancer that has come back (relapsed) after initial treatment with surgery and chemotherapy.
You have good kidney, liver, and bone marrow organ function.
You are fully active or able to carry out light work such as housework or office work.

Who cannot join

You have received pemetrexed or gemcitabine in the past for lung cancer
You are currently receiving another treatment for your relapsed lung cancer, or have had chemotherapy or certain other therapies for relapsed lung cancer in the past
You are unable to take corticosteroid drugs like dexamethasone
You are unable or unwilling to take the folic acid pills or Vitamin B12 injections that are required for the study
You are unable to stop taking aspirin or other drugs that control inflammation for certain periods of time during the study
You have had a heart attack in the last 6 months, or have other heart problems that are not controlled with medication

Trial locations and contacts

17 sites in 3 countries.

Country

City, postcode or hospital

17 sites in 3 countries

United States11 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.
Chapel Hill, North Carolina, 27599
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.
Chattanooga, Tennessee, 37404
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.
Evanston, Illinois, 60201
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.
Houston, Texas, 77060
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.
Memphis, Tennessee, 38120
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.
Miami, Florida, 33179
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.
Minneapolis, Minnesota, 55455
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.
Nashville, Tennessee, 37203
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.
Omaha, Nebraska, 68114
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.
St Louis, Missouri, 63110
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.
Wichita, Kansas, 67214

Other trials in United States

Brazil3 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.
Caxias do Sul, 95070560
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.
Porto Alegre, 90430-090
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.
Santo André, 09090780

Other trials in Brazil

India3 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.
Bangalore, 560 029
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.
Mumbai, 400016
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.
Trivandrum, 695011

Other trials in India

About this study

Official title: Phase II, Randomized, Open-Label Trial of Biweekly Pemetrexed Plus Gemcitabine vs. Pemetrexed or Pemetrexed Plus Carboplatin in Relapsed Non Small Cell Lung Cancer After Neoadjuvant or Adjuvant Chemotherapy

The purpose of this study is to help answer:

Whether pemetrexed, gemcitabine and/or carboplatin can shrink tumor(s) or make tumor(s) disappear in patients with relapsed lung cancer (lung cancer that has come back after surgical removal and chemotherapy), and to determine how long this will last
Whether pemetrexed, gemcitabine and/or carboplatin can help patients with relapsed lung cancer live longer

Conditions: Lung Neoplasms
Being tested: pemetrexed, gemcitabine, carboplatin
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
500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression
gemcitabineDrug
Also called LY188011, Gemzar
1500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression
carboplatinDrug
area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
PemetrexedDrug
Also called LY231514, Alimta
500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression

Study groups in NCT00356525
Study group	Role	What they receive
Less Than One Year: Pemetrexed	Experimental	Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy Receives: Drug: pemetrexed; Drug: gemcitabine
Less Than One Year: Pemetrexed + Gemcitabine	Experimental	Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy Receives: Drug: Pemetrexed
One Year or Greater: Pemetrexed + Carboplatin	Experimental	Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy Receives: Drug: carboplatin; Drug: Pemetrexed
One Year or Greater: Pemetrexed + Gemcitabine	Experimental	Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy Receives: Drug: pemetrexed; Drug: gemcitabine

What is being measured

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

Objective Tumor Response
Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. 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 time of response (up to 17.5 months)

Secondary outcomes (4)

Overall Survival
Overall survival is the number of participants who were alive when the trial was terminated.
Measured: baseline to trial termination (17.5 months)
Time to Progressive Disease
Measured: baseline to measured progressive disease (up to 17.5 months)
Duration of Response
Measured: time of response to progressive disease (up to 17.5 months)
Time to Treatment Failure
Measured: baseline to stopping treatment (up to 17.5 months)

Timeline

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

Sep 2006Apr 2009

First posted26 Jul 2006 (estimated)
Study startSep 2006
Primary completionJun 2008
Study completionApr 2009

Why it stopped: Stopped early due to low enrollment

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: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00356525
Sponsor's protocol ID: 9934
Other IDs: H3E-US-S082
Status last verified: Aug 2010
First submitted: 24 Jul 2006
Last updated: 17 Aug 2010
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

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
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
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

All Lung Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II, Randomized, Open-Label Trial of Biweekly Pemetrexed Plus Gemcitabine vs. Pemetrexed or Pemetrexed Plus Carboplatin in Relapsed Non Small Cell Lung Cancer After Neoadjuvant or Adjuvant Chemotherapy
ClinicalTrials.gov ID: NCT00356525
Acronym / sponsor ID: 9934
Conditions: Lung Neoplasms
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Stopped early due to low enrollment
Enrolment: 41 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Sep 2006
Primary completion: Jun 2008 (actual)
Study completion: Apr 2009 (actual)
First posted: 26 Jul 2006 (estimated)
Results: Posted 29 Jul 2009

Clinical summary

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

The purpose of this study is to help answer:

Whether pemetrexed, gemcitabine and/or carboplatin can shrink tumor(s) or make tumor(s) disappear in patients with relapsed lung cancer (lung cancer that has come back after surgical removal and chemotherapy), and to determine how long this will last
Whether pemetrexed, gemcitabine and/or carboplatin can help patients with relapsed lung cancer live longer

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Less Than One Year: Pemetrexed	Experimental	Drug: pemetrexed, Drug: gemcitabineDisease relapse at less than one year after neoadjuvant/adjuvant chemotherapy
Less Than One Year: Pemetrexed + Gemcitabine	Experimental	Drug: PemetrexedDisease relapse at less than one year after neoadjuvant/adjuvant chemotherapy
One Year or Greater: Pemetrexed + Carboplatin	Experimental	Drug: carboplatin, Drug: PemetrexedDisease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy
One Year or Greater: Pemetrexed + Gemcitabine	Experimental	Drug: pemetrexed, Drug: gemcitabineDisease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

You have non-small cell lung cancer that has come back (relapsed) after initial treatment with surgery and chemotherapy.
You have good kidney, liver, and bone marrow organ function.
You are fully active or able to carry out light work such as housework or office work.

Key exclusion criteria (6 listed)

You have received pemetrexed or gemcitabine in the past for lung cancer
You are currently receiving another treatment for your relapsed lung cancer, or have had chemotherapy or certain other therapies for relapsed lung cancer in the past
You are unable to take corticosteroid drugs like dexamethasone
You are unable or unwilling to take the folic acid pills or Vitamin B12 injections that are required for the study
You are unable to stop taking aspirin or other drugs that control inflammation for certain periods of time during the study

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, Alimta500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression	Drug	Less Than One Year: Pemetrexed, One Year or Greater: Pemetrexed + Gemcitabine
gemcitabineAlso: LY188011, Gemzar1500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression	Drug	Less Than One Year: Pemetrexed, One Year or Greater: Pemetrexed + Gemcitabine
carboplatinarea under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression	Drug	One Year or Greater: Pemetrexed + Carboplatin
PemetrexedAlso: LY231514, Alimta500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression	Drug	Less Than One Year: Pemetrexed + Gemcitabine, One Year or Greater: Pemetrexed + Carboplatin

Primary outcome

Objective Tumor Response
Time frame: baseline to time of response (up to 17.5 months)
Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. 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

Overall Survival
Time frame: baseline to trial termination (17.5 months)
Time to Progressive Disease
Time frame: baseline to measured progressive disease (up to 17.5 months)
Duration of Response
Time frame: time of response to progressive disease (up to 17.5 months)
Time to Treatment Failure
Time frame: baseline to stopping treatment (up to 17.5 months)

Results and safety

Results posted to the registry on 29 Jul 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
Less Than One Year: Pemetrexed	14	0
Less Than One Year: Pemetrexed + Gemcitabine	11	0
One Year or Greater: Pemetrexed + Carboplatin	7	0
One Year or Greater: Pemetrexed + Gemcitabine	9	0

Primary outcome: Objective Tumor Response

Time frame: baseline to time of response (up to 17.5 months). Number. Unit: participants

Measure	Less Than One Year: Pemetrexed n = 14	Less Than One Year: Pemetrexed + Gemcitabine n = 11	One Year or Greater: Pemetrexed + Carboplatin n = 7	One Year or Greater: Pemetrexed + Gemcitabine n = 9
Complete Response	0	0	0	0
Partial Response	7	0	2	1
Stable Disease	3	9	5	6
Progressive Disease	2	2	0	1
Unknown	2	0	0	1

Population analysed: Number of randomized participants in each category.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Less Than One Year: Pemetrexed	3 of 14 (21.4%)	14 of 14 (100%)	Not reported
Less Than One Year: Pemetrexed + Gemcitabine	5 of 11 (45.5%)	11 of 11 (100%)	Not reported
One Year or Greater: Pemetrexed + Carboplatin	0 of 7 (0%)	7 of 7 (100%)	Not reported
One Year or Greater: Pemetrexed + Gemcitabine	2 of 9 (22.2%)	9 of 9 (100%)	Not reported

Limitations and caveats (from the sponsor): The trial terminated early due to slow enrollment. Secondary outcomes were not analyzed due to insufficient data. Original results reported were interim analyses. Results have now been updated with final data.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Lilly Clinical Trial RegistryLink provided by the sponsor.

Related trials for Lung Neoplasms

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RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
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Streamlined Geriatric and Oncological Evaluation Based On IC Technology
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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)
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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

17 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pemetrexed, gemcitabine and carboplatin in people with Lung Neoplasms, run by Eli Lilly and Company at 17 sites in 3 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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 17 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, Brazil, India. 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 29 Jul 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?

Objective Tumor Response (time frame: baseline to time of response (up to 17.5 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 NCT00356525.

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 17 Aug 2010.