Carcinoma, Non-Small Cell LungPhase 2NCT00190840

A Single Arm Phase 2 Study of Pemetrexed as 2nd-Line Treatment of Advanced Non-Small Cell Lung Cancer

A Phase 2 study testing pemetrexed in people with Carcinoma, Non-Small Cell Lung, run by Eli Lilly and Company at 20 sites in 8 countries.

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Carcinoma, Non-Small Cell Lung
What is being tested?: pemetrexed
How many people: 186 participants
Where: 20 sitesin 8 countries
Study dates: Sep 2003to Oct 2005
Phase: Phase 2
Are there results?: None posted in the registry

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

diagnosis of NSCLC
Locally advanced or metastatic disease (Stage IIIB or IV).
Patients must have previously received one chemotherapy regimen for palliative therapy of locally advanced or metastatic disease.
Disease status must be that of measurable disease as defined by RECIST criteria
Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale; and adequate organ function.

Who cannot join

Known or suspected brain metastasis, or Second primary malignancy that is clinically detectable at the time of consideration for study enrollment
Concurrent administration of any other tumor therapy.
History of significant neurological or mental disorder, including seizures or dementia; or any other serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study
Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) 2 days before, the day of, and 2 days after the dose of pemetrexed.
Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone

Trial locations and contacts

20 sites in 8 countries.

Country

City, postcode or hospital

20 sites in 8 countries

India5 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.
Chandigarh, 160012
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.
Chennai, 600035
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.
Delhi, 110085
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.
Hyderabad, Andhra Pradesh, 500004
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.
Ludhiana, Punjab, 141001

Other trials in India

Australia4 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.
Ashford, South Australia, 5035
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.
Chermside, Queensland, 4032
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.
Fitzroy, Victoria, 3065
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.
Wollongong, New South Wales, 2500

Other trials in Australia

Romania4 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.
Bucharest, 72435
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.
Craiova, Dolj, 1100
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.
Iași, 6600
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.
Oradea, Bihor County, 3700

Other trials in Romania

Egypt2 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.
Alexandria
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.
Cairo, 11796

Other trials in Egypt

South Korea2 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.
Goyang-si, Gyeonggi-do, 411764
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.
Seoul

Other trials in South Korea

China1 site

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.
Hong Kong

Other trials in China

Taiwan1 site

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.
Taipei

Other trials in Taiwan

Turkey (Türkiye)1 site

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.
Eskişehir

Other trials in Turkey (Türkiye)

About this study

Official title: Open-Label Single-Arm Phase 2 Study of ALIMTA in Patients With Advanced Non-Small Cell Lung Cancer Who Have Had Prior Chemotherapy

In previous phase 2 studies, pemetrexed has shown antitumor activity in advanced non-small cell lung cancer as a single agent as well as in combination with cisplatin. Since the introduction of vitamin supplementation, pemetrexed has shown good tolerance and high safety. Vitamin supplementation has opened the opportunity to offer patients higher pemetrexed dosing, as has been demonstrated by a recent Phase 1 study. The higher dose with supplementation may increase pemetrexed's efficacy without unduly compromising safety. The present Phase 2 study will use pemetrexed dosing that is tailored to individual patient tolerance, and is an effort to determine the efficacy and safety of this approach in patients with advanced NSCLC who had prior chemotherapy.

Conditions: Carcinoma, Non-Small Cell Lung
Being tested: pemetrexed
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.

pemetrexedDrug

What is being measured

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

Response rate according to RECIST criteria

Secondary outcomes (6)

To assess the following time to event efficacy variables:
o Duration of overall response for responding patients
o Time to progressive disease
o Time to treatment failure
o Survival
To characterize the quantitative and qualitative toxicity of pemetrexed when used at tailored dosing in this patient population

Timeline

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

Sep 2003Oct 2005

First posted19 Sep 2005 (estimated)
Study startSep 2003
Study completionOct 2005

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Carcinoma, Non-Small Cell LungStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 186 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00190840
Sponsor's protocol ID: 6685
Other IDs: H3E-AA-S037
Status last verified: Jan 2007
First submitted: 12 Sep 2005
Last updated: 26 Jan 2007
Results posted: 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 2
A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer
Carcinoma, Non-small-Cell Lung
RecruitingPhase 1/2
FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC
Ovarian Cancer, Non-small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer
Advanced or Metastatic Non-small Cell Lung Cancer
RecruitingPhase 1/2
A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors
Hepatocellular Carcinoma (HCC), Metastatic Uveal Melanoma
Active, not recruitingPhase 3
REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumors)
Advanced or Metastatic NSCLS With Exon 20 Insertion Mutation

All Carcinoma, Non-Small Cell Lung trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-Label Single-Arm Phase 2 Study of ALIMTA in Patients With Advanced Non-Small Cell Lung Cancer Who Have Had Prior Chemotherapy
ClinicalTrials.gov ID: NCT00190840
Acronym / sponsor ID: 6685
Conditions: Carcinoma, Non-Small Cell Lung
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 186 participants
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Sep 2003
Study completion: Oct 2005
First posted: 19 Sep 2005 (estimated)
Results: Not posted in the source record

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)

Who may qualify

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

Key inclusion criteria (5 listed)

diagnosis of NSCLC
Locally advanced or metastatic disease (Stage IIIB or IV).
Patients must have previously received one chemotherapy regimen for palliative therapy of locally advanced or metastatic disease.
Disease status must be that of measurable disease as defined by RECIST criteria
Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale; and adequate organ function.

Key exclusion criteria (5 listed)

Known or suspected brain metastasis, or Second primary malignancy that is clinically detectable at the time of consideration for study enrollment
Concurrent administration of any other tumor therapy.
History of significant neurological or mental disorder, including seizures or dementia; or any other serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study
Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) 2 days before, the day of, and 2 days after the dose of pemetrexed.
Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone

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	Drug	–

Primary outcome

Response rate according to RECIST criteria

6 secondary outcomes

To assess the following time to event efficacy variables:
o Duration of overall response for responding patients
o Time to progressive disease
o Time to treatment failure
o Survival
To characterize the quantitative and qualitative toxicity of pemetrexed when used at tailored dosing in this patient population

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2007.

Related trials for Carcinoma, Non-Small Cell Lung

RecruitingPhase 2
A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer
Carcinoma, Non-small-Cell Lung
RecruitingPhase 1/2
FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC
Ovarian Cancer, Non-small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer
Advanced or Metastatic Non-small Cell Lung Cancer
RecruitingPhase 1/2
A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors
Hepatocellular Carcinoma (HCC), Metastatic Uveal Melanoma
Active, not recruitingPhase 3
REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumors)
Advanced or Metastatic NSCLS With Exon 20 Insertion Mutation

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

20 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pemetrexed in people with Carcinoma, Non-Small Cell Lung, run by Eli Lilly and Company at 20 sites in 8 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 5 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 26 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in India, Australia, Romania, Egypt, South Korea and 3 more countries. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Response rate according to RECIST criteria. 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 NCT00190840.

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 26 Jan 2007; AzTrials last refreshed its copy on 3 Nov 2026.