Non Small Cell Lung CancerPhase 2NCT00370292

Dosage Schedule Study of Pemetrexed Monochemotherapy for Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

A Phase 2 study testing Pemetrexed - Before Protocol Amendment and Pemetrexed - After Protocol Amendment in people with Non Small Cell Lung Cancer, run by Eli Lilly and Company at 1 site in Italy.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Non Small Cell Lung Cancer
What is being tested?: Pemetrexed - Before Protocol Amendment and Pemetrexed - After Protocol Amendment
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteItaly
Study dates: Sep 2006to Sep 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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically or cytologically proven IIIB and IV NSCLC.
No symptomatic uncontrolled brain metastasis
Not suitable for platinum containing regimens if chemo-naive
Performance status less than or equal to 2 on the Eastern Cooperative Oncology Group (ECOG) Scale.
Creatinine Clearance (CrCl) greater than or equal to 45 milliliters per min (mL/min)

Who cannot join

Prior radiation to greater than 25% of bone marrow
Inability to interrupt Aspirin at doses of greater than 1.3 grams/day or non-steroidal anti-inflammatory agents for a 5-day period.
Presence of clinically relevant third-space fluid collections not controllable.
Significant cardiac disease

Trial locations and contacts

1 site in 1 country.

Italy1 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.
Milan

Other trials in Italy

About this study

Official title: Pemetrexed Monochemotherapy in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer. A Pilot Study to Define the Best Dosing Schedule for a Planned Phase II Randomized Trial

Patients affected by non-small cell lung cancer (NSCLC) will be treated in pemetrexed monochemotherapy regimen for a maximum of 8 cycles. Pemetrexed is an enhancer of some biomolecules involved in the gemcitabine mechanism of action. Purpose of the trial is to monitor the blood values of these biomolecules at different time intervals, to optimize the synergism between pemetrexed and gemcitabine.

Conditions: Non Small Cell Lung Cancer
Being tested: Pemetrexed - Before Protocol Amendment, Pemetrexed - After Protocol Amendment
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 - Before Protocol AmendmentDrug
Also called LY231514, Alimta
500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles or disease progression, unacceptable toxicity or patient decision to discontinue
Pemetrexed - After Protocol AmendmentDrug
Also called LY231514, Alimta
500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 6 cycles or disease progression, unacceptable toxicity or patient decision to discontinue.

Study groups in NCT00370292
Study group	Role	What they receive
Pemetrexed - Before Protocol Amendment	Experimental	Not described Receives: Drug: Pemetrexed - Before Protocol Amendment
Pemetrexed - After Protocol Amendment	Experimental	Not described Receives: Drug: Pemetrexed - After Protocol Amendment

What is being measured

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

Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3
dCK and hENT expression (see Outcome #2) on normal lymphocytes were measured after Pemetrexed administration to evaluate if there was reproducible timing of maximum dCK expression, and to assess proper time interval between pemetrexed and gemcitabine for treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC). Values are calculated as ratio between thereshold cycles (number of polymerase chain reaction [PCR] cycles) with respect to a reference gene; in this case glyceraldehyde 3-phosphate dehydrogenase (GAPDH).
Measured: pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles)
Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3
dCK (see Outcome #1)and hENT expression (see Outcome #2) on normal lymphocytes were measured after Pemetrexed administration to evaluate if there was reproducible timing of maximum dCK expression, and to assess proper time interval between pemetrexed and gemcitabine for treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC). Values are calculated as ratio between thereshold cycles (number of polymerase chain reaction [PCR] cycles) with respect to a reference gene; in this case glyceraldehyde 3-phosphate dehydrogenase (GAPDH).
Measured: pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles)

Secondary outcomes (1)

Best Objective Tumor Response
Response 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 measured response (every 14 days for 6 cycles)

Timeline

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

Sep 2006Sep 2008

First posted31 Aug 2006 (estimated)
Study startSep 2006
Primary completionSep 2008
Study completionSep 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00370292
Sponsor's protocol ID: 10940
Other IDs: H3E-IT-S105
Status last verified: Oct 2009
First submitted: 29 Aug 2006
Last updated: 20 Oct 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

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

All Non Small Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pemetrexed Monochemotherapy in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer. A Pilot Study to Define the Best Dosing Schedule for a Planned Phase II Randomized Trial
ClinicalTrials.gov ID: NCT00370292
Acronym / sponsor ID: 10940
Conditions: Non Small Cell Lung Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Sep 2006
Primary completion: Sep 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 31 Aug 2006 (estimated)
Results: Posted 12 Oct 2009

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: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Pemetrexed - Before Protocol Amendment	Experimental	Drug: Pemetrexed - Before Protocol Amendment
Pemetrexed - After Protocol Amendment	Experimental	Drug: Pemetrexed - After Protocol Amendment

Who may qualify

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

Key inclusion criteria (5 listed)

Histologically or cytologically proven IIIB and IV NSCLC.
No symptomatic uncontrolled brain metastasis
Not suitable for platinum containing regimens if chemo-naive
Performance status less than or equal to 2 on the Eastern Cooperative Oncology Group (ECOG) Scale.
Creatinine Clearance (CrCl) greater than or equal to 45 milliliters per min (mL/min)

Key exclusion criteria (4 listed)

Prior radiation to greater than 25% of bone marrow
Inability to interrupt Aspirin at doses of greater than 1.3 grams/day or non-steroidal anti-inflammatory agents for a 5-day period.
Presence of clinically relevant third-space fluid collections not controllable.
Significant cardiac disease

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 - Before Protocol AmendmentAlso: LY231514, Alimta500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles or disease progression, unacceptable toxicity or patient decision to discontinue	Drug	Pemetrexed - Before Protocol Amendment
Pemetrexed - After Protocol AmendmentAlso: LY231514, Alimta500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 6 cycles or disease progression, unacceptable toxicity or patient decision to discontinue.	Drug	Pemetrexed - After Protocol Amendment

Primary outcome

Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3
Time frame: pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles)
dCK and hENT expression (see Outcome #2) on normal lymphocytes were measured after Pemetrexed administration to evaluate if there was reproducible timing of maximum dCK expression, and to assess proper time interval between pemetrexed and gemcitabine for treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC). Values are calculated as ratio between thereshold cycles (number of polymerase chain reaction [PCR] cycles) with respect to a reference gene; in this case glyceraldehyde 3-phosphate dehydrogenase (GAPDH).
Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3
Time frame: pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles)
dCK (see Outcome #1)and hENT expression (see Outcome #2) on normal lymphocytes were measured after Pemetrexed administration to evaluate if there was reproducible timing of maximum dCK expression, and to assess proper time interval between pemetrexed and gemcitabine for treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC). Values are calculated as ratio between thereshold cycles (number of polymerase chain reaction [PCR] cycles) with respect to a reference gene; in this case glyceraldehyde 3-phosphate dehydrogenase (GAPDH).

1 secondary outcome

Best Objective Tumor Response
Time frame: baseline to measured response (every 14 days for 6 cycles)

Results and safety

Results posted to the registry on 12 Oct 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	19	6

Primary outcome: Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3

Time frame: pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles). Mean (Standard Deviation). Unit: mRNA relative values (ratio with GAPDH)

Measure	dCK - Cycle 1 n = 19	dCK - Cycle 2 n = 19	dCK - Cycle 3 n = 19
Pre-Dose	0.92 (0.03)	0.92 (0.03)	0.92 (0.02)
1 Hour Post-Dose	0.96 (0.04)	0.95 (0.03)	0.96 (0.03)
2 Hours Post-Dose	0.96 (0.04)	0.96 (0.04)	0.97 (0.02)
4 Hours Post-Dose	0.93 (0.04)	0.94 (0.04)	0.92 (0.03)
6 Hours Post-Dose	0.92 (0.03)	0.91 (0.04)	0.91 (0.03)
24 Hours Post-Dose	0.96 (0.04)	0.97 (0.03)	0.96 (0.03)
48 Hours Post-Dose	0.97 (0.04)	0.96 (0.04)	0.97 (0.03)

dCK - Cycle 1 vs dCK - Cycle 2 vs dCK - Cycle 3: p <0.001, Repeated Measures Analysis of Variance
dCK - Cycle 1 vs dCK - Cycle 2 vs dCK - Cycle 3: p <0.001, Repeated Measures Analysis of Variance
dCK - Cycle 1 vs dCK - Cycle 2 vs dCK - Cycle 3: p = 0.030, Repeated Measures Analysis of Variance

Population analysed: All participants who received at least one dose of study drug.

Primary outcome: Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3

Time frame: pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles). Mean (Standard Deviation). Unit: mRNA relative values (ratio with GAPDH)

Measure	hENT - Cycle 1 n = 19	hENT - Cycle 2 n = 19	hENT - Cycle 3 n = 19
Pre-Dose	0.86 (0.03)	0.86 (0.03)	0.87 (0.02)
1 Hour Post-Dose	0.88 (0.04)	0.89 (0.04)	0.90 (0.03)
2 Hours Post-Dose	0.88 (0.04)	0.90 (0.04)	0.90 (0.04)
4 Hours Post-Dose	0.86 (0.04)	0.88 (0.05)	0.86 (0.03)
6 Hours Post-Dose	0.86 (0.04)	0.86 (0.04)	0.86 (0.02)
24 Hours Post-Dose	0.89 (0.04)	0.91 (0.04)	0.91 (0.02)
48 Hours Post-Dose	0.90 (0.04)	0.91 (0.04)	0.91 (0.02)

hENT - Cycle 1 vs hENT - Cycle 2 vs hENT - Cycle 3: p <0.001, Repeated Measures Analysis of Variance
hENT - Cycle 1 vs hENT - Cycle 2 vs hENT - Cycle 3: p <0.001, Repeated Measures Analysis of Variance
hENT - Cycle 1 vs hENT - Cycle 2 vs hENT - Cycle 3: p = 0.333, Repeated Measures Analysis of Variance

Population analysed: Number of participants who received at least one dose of study drug.

1 secondary outcome is 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	5 of 19 (26.3%)	19 of 19 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

1 site 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 - Before Protocol Amendment and Pemetrexed - After Protocol Amendment in people with Non Small Cell Lung Cancer, run by Eli Lilly and Company at 1 site in Italy.

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 4 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 20 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. 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 12 Oct 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?

Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 (time frame: pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles)). The study lists 2 primary outcomes in all. 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 NCT00370292.

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 20 Oct 2009.