Non-small Cell Lung CancerPhase 2NCT00530621

Study of Enzastaurin Versus Placebo With Pemetrexed for Participants With Advanced or Metastatic Lung Cancer

A Phase 2 study testing enzastaurin and pemetrexed in people with Non-small Cell Lung Cancer, run by Eli Lilly and Company at 25 sites in 6 countries.

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

The purpose of this study is to determine if the combination of enzastaurin and pemetrexed can extend survival time without progression of disease for participants who have advanced or metastatic non-small cell lung cancer (NSCLC). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-small Cell Lung Cancer
What is being tested?: enzastaurin and pemetrexed
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 160 participants
Where: 25 sitesin 6 countries
Study dates: Sep 2007to Oct 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

Laboratory confirmed diagnosis of NSCLC with locally advanced or metastatic disease which cannot be cured.
Participants must have disease which progressed after 1 prior systemic cytotoxic chemotherapy regimen for advanced disease.
At least 1 measurable lesion.
Must have stopped all previous systemic therapies for cancer for at least 2 weeks prior to enrollment.
Must be able to follow study guidelines and be able to show up for appointments.

Who cannot join

Treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Previous treatment with enzastaurin or pemetrexed.
Concurrent administration of any other antitumor therapy.
Inability to swallow tablets.
Pregnant or breastfeeding.

Trial locations and contacts

25 sites in 6 countries.

Country

City, postcode or hospital

25 sites in 6 countries

United States10 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.
Dayton, Ohio, 45429
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Fayetteville, Arkansas, 72703
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Fort Worth, Texas, 76104
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Lancaster, California, 93534
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Los Angeles, California, 90095
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Memphis, Tennessee, 38120
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Richardson, Texas, 75080
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Scarborough, Maine, 04074
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Tampa, Florida, 33612
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Wichita, Kansas, 67214

Other trials in United States

France5 sites

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Grenoble, 38043
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Marseille, 13009
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Saint-Herblain, 44805
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Toulouse, 31059
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Villejuif, 94805

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Germany3 sites

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Cologne, D-51109
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Gauting, 82131
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Großhansdorf, D-22927

Other trials in Germany

Italy3 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.
Aviano, 33081
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Genova, 16132
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Orbassano, 10043

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Portugal3 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.
Coimbra, 3040-853
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Lisbon, 1099-035
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Porto, 4200-072

Other trials in Portugal

South Korea1 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.
Seoul, 135-710

Other trials in South Korea

About this study

Official title: A Phase 2 Double-Blind Randomized Study of Oral Enzastaurin HCl Versus Placebo Concurrently With Pemetrexed (Alimta®) as Second-Line Therapy in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

Conditions: Non-small Cell Lung Cancer
Being tested: enzastaurin, placebo, 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.

enzastaurinDrug
Also called LY317615
1125 milligrams (mg) loading dose then 500 mg, oral, daily Cycle 1 (28 days), subsequent cycles 21 days, until disease progression
placeboDrug
oral, daily
pemetrexedDrug
Also called LY231514, Alimta
500 milligrams per square meter (mg/m^2), intravenous (IV), day 8 Cycle 1 (28 days), day 1 subsequent cycles (21 days), until disease progression

Study groups in NCT00530621
Study group	Role	What they receive
Pemetrexed + Enzastaurin	Experimental	Not described Receives: Drug: enzastaurin; Drug: pemetrexed
Pemetrexed + Placebo	Placebo comparator	Not described Receives: Drug: placebo; Drug: pemetrexed

What is being measured

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

Progression-Free Survival (PFS)
PFS was defined as the time from date of randomization to the first documented observation of disease progression or death from any cause. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Progressive disease (PD) was defined as having at least a 20% increase in sum of the longest diameter of target lesions or the appearance of new lesions. PFS was censored at the date of the last objective progression-free disease assessment for participants who did not experience PD or death at the data inclusion cut-off date.
Measured: Baseline to measured progressive disease up to 9.92 months

Secondary outcomes (5)

Overall Survival (OS)
OS was defined as the duration from the date of randomization to the date of death from any cause. For participants who were alive at the time of the data inclusion cutoff, OS was censored at the date the participant was last known to be alive.
Measured: Baseline to date of death from any cause up to 12.32 months
Time-to-Worsening (TW) in Lung Cancer Symptom Scale (LCSS) - Health Related Quality of Life (HRQoL) Subscale
LCSS is a participant rated lung cancer instrument which consisted of 6 disease related symptoms (appetite, cough, fatigue, dyspnea, hemoptysis, and pain) and 3 quality of life (QoL) items (activity status, symptomatic distress, and overall QoL). TW in LCSS-HRQoL was measured from the date of enrollment to the first date of a 15 millimeters (mm) worsening in the 9th LCSS item on QoL. LCSS-HRQoL was measured on the 100-mm visual analogue scale (VAS) with the scores ranging from 0 (best response and very high HRQoL) to 100-mm (worse response and very low HRQoL). TW-HRQoL was censored at the date of the participant's last LCSS assessment for participant without a 15-mm increase on the 100-mm VAS.
Measured: Baseline to disease worsening up to 10.58 months
Duration of Disease Control (DDC)
DDC was defined as the time from randomization to the first documented observation of disease progression or death from any cause and was limited to the participants with a best tumor response of complete response (CR), partial response (PR), or stable disease (SD). Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Progressive disease (PD) was defined as having at least a 20% increase in sum of the longest diameter of target lesions or the appearance of new lesions. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. SD was defined as small changes that did not meet the above criteria. DDC was censored at the date of the last objective progression-free disease assessment for participants who did not experience PD or death.
Measured: Baseline to measured progressive disease up to 9.92 months
Percentage of Participants With Complete Response or Partial Response (Tumor Response Rate)
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Participants with a best response of complete response (CR) or partial response (PR) were considered to have had a tumor response. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Percentage of participants was calculated as the total number of participants affected divided by the number of participants analyzed then multiplied by 100.
Measured: Baseline to measured progressive disease up to 9.92 months
Tumor Biomarkers
Protein expression was measured using an Immunohistochemistry (IHC) assay from the tumor tissue samples. IHC histo-scores (H-scores) were determined separately for each of the 3 biomarkers: folate receptor alpha (FR alpha) in cytoplasm and apical membrane, thymidylate synthase (TS) in cytoplasm and nucleus, and thyroid transcription factor-1 (TTF1) in the nucleus. Tumor tissue samples were to be scored using a 0 (negative, no staining) to 3+ (brightest staining) scoring system for cytoplasmic and nuclear staining. IHC H-score was calculated using the formula: 1 * (percentage of cells stained 1+) + 2 * (percentage of cells stained 2+) + 3 * (percentage of cells stained 3+), giving a minimum score of 0 to a maximum score of 300. The maximum score indicates the strongest expression.
Measured: Tumor samples collected at baseline

Timeline

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

Sep 2007Oct 2008

First posted17 Sep 2007 (estimated)
Study startSep 2007
Primary completionOct 2008
Study completionOct 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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00530621
Sponsor's protocol ID: 9820
Other IDs: H6Q-MC-JCBT
Status last verified: Jun 2020
First submitted: 13 Sep 2007
Last updated: 1 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Double-Blind Randomized Study of Oral Enzastaurin HCl Versus Placebo Concurrently With Pemetrexed (Alimta®) as Second-Line Therapy in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT00530621
Acronym / sponsor ID: 9820
Conditions: Non-small Cell Lung Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Sep 2007
Primary completion: Oct 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 17 Sep 2007 (estimated)
Results: Posted 1 Jul 2020

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: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Pemetrexed + Enzastaurin	Experimental	Drug: enzastaurin, Drug: pemetrexed
Pemetrexed + Placebo	Placebo comparator	Drug: placebo, Drug: pemetrexed

Who may qualify

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

Key inclusion criteria (5 listed)

Laboratory confirmed diagnosis of NSCLC with locally advanced or metastatic disease which cannot be cured.
Participants must have disease which progressed after 1 prior systemic cytotoxic chemotherapy regimen for advanced disease.
At least 1 measurable lesion.
Must have stopped all previous systemic therapies for cancer for at least 2 weeks prior to enrollment.
Must be able to follow study guidelines and be able to show up for appointments.

Key exclusion criteria (5 listed)

Treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Previous treatment with enzastaurin or pemetrexed.
Concurrent administration of any other antitumor therapy.
Inability to swallow tablets.
Pregnant or breastfeeding.

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
enzastaurinAlso: LY3176151125 milligrams (mg) loading dose then 500 mg, oral, daily Cycle 1 (28 days), subsequent cycles 21 days, until disease progression	Drug	Pemetrexed + Enzastaurin
placebooral, daily	Drug	Pemetrexed + Placebo
pemetrexedAlso: LY231514, Alimta500 milligrams per square meter (mg/m^2), intravenous (IV), day 8 Cycle 1 (28 days), day 1 subsequent cycles (21 days), until disease progression	Drug	Pemetrexed + Enzastaurin, Pemetrexed + Placebo

Primary outcome

Progression-Free Survival (PFS)
Time frame: Baseline to measured progressive disease up to 9.92 months
PFS was defined as the time from date of randomization to the first documented observation of disease progression or death from any cause. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.0) criteria. Progressive disease (PD) was defined as having at least a 20% increase in sum of the longest diameter of target lesions or the appearance of new lesions. PFS was censored at the date of the last objective progression-free disease assessment for participants who did not experience PD or death at the data inclusion cut-off date.

5 secondary outcomes

Overall Survival (OS)
Time frame: Baseline to date of death from any cause up to 12.32 months
Time-to-Worsening (TW) in Lung Cancer Symptom Scale (LCSS) - Health Related Quality of Life (HRQoL) Subscale
Time frame: Baseline to disease worsening up to 10.58 months
Duration of Disease Control (DDC)
Time frame: Baseline to measured progressive disease up to 9.92 months
Percentage of Participants With Complete Response or Partial Response (Tumor Response Rate)
Time frame: Baseline to measured progressive disease up to 9.92 months
Tumor Biomarkers
Time frame: Tumor samples collected at baseline

Results and safety

Results posted to the registry on 1 Jul 2020, 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 + Enzastaurin	80	0
Pemetrexed + Placebo	80	0

Primary outcome: Progression-Free Survival (PFS)

Time frame: Baseline to measured progressive disease up to 9.92 months. Median (95% Confidence Interval). Unit: months

Measure	Pemetrexed + Enzastaurin n = 80	Pemetrexed + Placebo n = 80
Value	2.96 (1.87 to 3.58)	3.02 (1.74 to 3.98)

Pemetrexed + Enzastaurin vs Pemetrexed + Placebo: Hazard Ratio (HR): 1.13 (95% CI 0.77 to 1.65), p = 0.544, Log Rank

Population analysed: All randomized participants. Twenty five (25) participants in Pemetrexed + Enzastaurin group and twenty three (23) participants in Pemetrexed + Placebo group were censored for analysis.

5 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
Pemetrexed + Enzastaurin	33 of 79 (41.8%)	73 of 79 (92.4%)	Not reported
Pemetrexed + Placebo	30 of 80 (37.5%)	75 of 80 (93.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
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

25 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing enzastaurin and pemetrexed in people with Non-small Cell Lung Cancer, run by Eli Lilly and Company at 25 sites in 6 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 1 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States, France, Germany, Italy, Portugal and 1 more country. 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. Some participants in this study may receive a placebo. 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 1 Jul 2020). 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?

Progression-Free Survival (PFS) (time frame: Baseline to measured progressive disease up to 9.92 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 NCT00530621.

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 1 Jul 2020.