Non-Small-Cell Lung CancerPhase 2NCT00383331

Pemetrexed and Gemcitabine Every 14 Days Versus Every 21 Days in Advanced Non Small Cell Lung Cancer

A Phase 2 study testing Pemetrexed and Gemcitabine in people with Non-Small-Cell Lung Cancer, run by Eli Lilly and Company at 1 site in United States.

Terminated

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

Official record

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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 and Gemcitabine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteUnited States
Study dates: Feb 2007to Jan 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

histologic or cytologic diagnosis of NSCLC Stage IIIB or IV
no prior systemic chemotherapy for advanced Non-Small Cell Lung Cancer
Prior radiotherapy must be completed at least 4 weeks before study enrollment.

Who cannot join

estimated life expectancy of 12 weeks
a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease
documented brain metastases unless the patient has completed successful local therapy for central nervous system metastases and has been off of corticosteroids for at least 2 weeks before enrollment
significant weight loss (that is, > 10%) over the previous 6 weeks before study entry.

Trial locations and contacts

1 site in 1 country.

United States1 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.
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: A Phase II Study of ALIMTA® (Pemetrexed) and GEMZAR® (Gemcitabine) Every 14 Days Versus Pemetrexed and Gemcitabine Every 21 Days in Advanced Non-Small Cell Lung Cancer

This study is designed to evaluate Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8 every 21 days (Arm A) and Pemetrexed and Gemcitabine Day 1 every 14 days (Arm B) in patients with NSCLC. Each agent and sequence has well demonstrated antitumor activity respectively in patients with locally advanced or metastatic NSCLC. Therefore, it is reasonable to investigate the most optimal schedule for this combination, and which combination is associated with the most anti-tumor activity in the phase II arena.

Conditions: Non-Small-Cell Lung Cancer
Being tested: Pemetrexed, Gemcitabine
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
Also called LY231514, Alimta
A: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles
B: 500 mg/m2, intravenous (IV), every 14 days x 9 cycles
GemcitabineDrug
Also called LY188011, Gemzar
A: 1250 mg/m2, intravenous (IV) days 1 and 8, every 21 days x 6 cycles
B: 1500 mg/m2, intravenous (IV), every 14 days x 9 cycles

Study groups in NCT00383331
Study group	Role	What they receive
A	Experimental	Not described Receives: Drug: Pemetrexed; Drug: Gemcitabine
B	Experimental	Not described Receives: Drug: Pemetrexed; Drug: Gemcitabine

What is being measured

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

Best Overall Tumor Response
Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.
Measured: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up

Secondary outcomes (5)

Progression Free Survival
baseline to measured progressive disease
Measured: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up
Time to Progressive Disease
Time to progressive disease not analyzed because trial was stopped early due to low enrollment.
Measured: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up
Duration of Response
Duration of response was not analyzed because the trial was stopped early due to low enrollment.
Measured: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up
Time to Treatment Failure
Time to treatment failure was not analyzed because the trial was stopped early due to low enrollment.
Measured: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up
Overall Survival
Survival time is defined as the time from date of randomization to death due to any cause.
Measured: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up

Timeline

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

Feb 2007Jan 2008

First posted3 Oct 2006 (estimated)
Study startFeb 2007
Primary completionJan 2008
Study completionJan 2008

Why it stopped: Trial was 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 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: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00383331
Sponsor's protocol ID: 9431
Other IDs: H3E-US-S061
Status last verified: May 2009
First submitted: 29 Sep 2006
Last updated: 3 Jun 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 3 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Study of ALIMTA® (Pemetrexed) and GEMZAR® (Gemcitabine) Every 14 Days Versus Pemetrexed and Gemcitabine Every 21 Days in Advanced Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT00383331
Acronym / sponsor ID: 9431
Conditions: Non-Small-Cell Lung Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Trial was stopped early due to low enrollment
Enrolment: 19 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Feb 2007
Primary completion: Jan 2008 (actual)
Study completion: Jan 2008 (actual)
First posted: 3 Oct 2006 (estimated)
Results: Posted 14 May 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
A	Experimental	Drug: Pemetrexed, Drug: Gemcitabine
B	Experimental	Drug: Pemetrexed, Drug: Gemcitabine

Who may qualify

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

Key inclusion criteria (3 listed)

histologic or cytologic diagnosis of NSCLC Stage IIIB or IV
no prior systemic chemotherapy for advanced Non-Small Cell Lung Cancer
Prior radiotherapy must be completed at least 4 weeks before study enrollment.

Key exclusion criteria (4 listed)

estimated life expectancy of 12 weeks
a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease
documented brain metastases unless the patient has completed successful local therapy for central nervous system metastases and has been off of corticosteroids for at least 2 weeks before enrollment
significant weight loss (that is, > 10%) over the previous 6 weeks before study entry.

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, AlimtaA: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles B: 500 mg/m2, intravenous (IV), every 14 days x 9 cycles	Drug	A, B
GemcitabineAlso: LY188011, GemzarA: 1250 mg/m2, intravenous (IV) days 1 and 8, every 21 days x 6 cycles B: 1500 mg/m2, intravenous (IV), every 14 days x 9 cycles	Drug	A, B

Primary outcome

Best Overall Tumor Response
Time frame: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up
Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.

5 secondary outcomes

Progression Free Survival
Time frame: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up
Time to Progressive Disease
Time frame: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up
Duration of Response
Time frame: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up
Time to Treatment Failure
Time frame: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up
Overall Survival
Time frame: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up

Results and safety

Results posted to the registry on 14 May 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
21-Day Cycle	10	10
14-Day Cycle	9	8

Primary outcome: Best Overall Tumor Response

Time frame: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up. Number. Unit: participants

Measure	21-Day Cycle n = 10	14-Day Cycle n = 8
Complete Response	0	0
Partial Response	2	0

21-Day Cycle vs 14-Day Cycle: p = 0.48, Fisher Exact

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 15% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
21-Day Cycle	9 of ?	10 of ?	Not reported
14-Day Cycle	4 of ?	9 of ?	Not reported

Limitations and caveats (from the sponsor): Trial was stopped early due to low enrollment. Some secondary outcomes were not analyzed due to the low numbers.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 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 and Gemcitabine in people with Non-Small-Cell Lung Cancer, run by Eli Lilly and Company at 1 site in United States.

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 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: stopped early, as of the sponsor's last update on 3 Jun 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 United States. 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 14 May 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 Tumor Response (time frame: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up). 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 NCT00383331.

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 3 Jun 2009.