Non-Small-Cell Lung CancerPhase 2NCT00550173

A Study for Non-Smoker Patients With Nonsquamous Non-Small Cell Lung Cancer

A Phase 2 study testing pemetrexed and erlotinib in people with Non-Small-Cell Lung Cancer, run by Eli Lilly and Company at 29 sites in 7 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

The purpose of this study is to compare the combination of erlotinib and pemetrexed versus either pemetrexed alone and erlotinib alone, in terms of progression-free survival (time until the objective worsening of the disease) in patients who have never smoked and have locally advanced or metastatic Nonsquamous… 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?: pemetrexed and erlotinib
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 247 participants
Where: 29 sitesin 7 countries
Study dates: Nov 2007to Jan 2012
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

Patients with locally advanced or metastatic nonsquamous non-small cell lung cancer
Patients must be non-smokers
Patients must have at least one measurable lesion
Performance status of 0 to 2 on the Eastern Cooperative Oncology Group Scale
Patients must have failed only one prior chemotherapy regimen and must be considered eligible for further chemotherapy following progression of their disease.

Who cannot join

Patients who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication
Patients who have previously received treatment with drugs against the human epidermal growth factor receptors
Patients who have previously received treatment with drugs which have similar targets as Pemetrexed
Patients who have any known significant ophthalmologic abnormalities of the surface of the eye
Patients who have a history of severe hypersensitivity reaction to erlotinib or pemetrexed

Trial locations and contacts

29 sites in 7 countries.

Country

City, postcode or hospital

29 sites in 7 countries

India11 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.
Ahmedabad, 380016
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Bhopal, 462001
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Hyderabaad, 500082
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Jaipur, 302013
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Kochi, 682304
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Kolkata, 700 026
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Madurai, 625020
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Mohali, 160062
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Mumbai, 400 026
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New Delhi, 110017
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Visakhapatnam, 530002

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United Kingdom5 sites

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Aberdeen, Scotland, AB25 2ZN
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Chelmsford, Essex, CM1 7ET
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Guildford, Surrey, GU2 7XX
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Manchester, United Kingdom, M20 4BX
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Poole, Dorset, BH15 2JB

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Brazil3 sites

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Barretos, 14784700
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Ijuí, 98700 000
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São Paulo, 01277-900

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China3 sites

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Beijing, 100730
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Nanning, 530000
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Shanghai, 200030

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South Korea3 sites

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Jinju, 660-702
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Seoul, 138-736
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Suwon, 442-723

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Taiwan3 sites

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Changhua, 500
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Taichung, 407
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Taoyuan, 333

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Hong Kong1 site

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Shatin

Other trials in Hong Kong

About this study

Official title: A Randomized Phase 2 Study Comparing Erlotinib-Pemetrexed, Pemetrexed Alone, and Erlotinib Alone, as Second-Line Treatment for Non-Smoker Patients With Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer

Conditions: Non-Small-Cell Lung Cancer
Being tested: pemetrexed, erlotinib
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
500 milligrams per meter squared (mg/m^2), intravenous (IV), every (q) 21 days until progression or unacceptable toxicity develops
erlotinibDrug
150 mg, orally, once daily until progression or unacceptable toxicity develops

Study groups in NCT00550173
Study group	Role	What they receive
Pemetrexed + Erlotinib	Experimental	Pemetrexed 500 milligrams per meter squared (mg/m^2) of body surface area, administered by intravenous (IV) infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months. Receives: Drug: pemetrexed; Drug: erlotinib
Erlotinib	Active comparator	Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months. Receives: Drug: erlotinib
Pemetrexed	Active comparator	Pemetrexed 500 mg/m^2 of body surface area, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months. Receives: Drug: pemetrexed

What is being measured

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

Progression-Free Survival (PFS)
PFS is defined as the time from randomization to the first date of progressive disease (PD; either objectively determined or clinical progression) or death from any cause. PD was defined as at least a 20% increase in sum of longest diameter of target lesions as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 guidelines. Time to disease progression was censored at the date of death.
Measured: Randomization to measured PD up to 38 months

Secondary outcomes (7)

Percentage of Participants With a Tumor Response of Complete Response (CR) or Partial Response (PR) [Tumor Response Rate (TRR)]
TRR was defined as the number of responders (complete or partial) divided by the number of participants qualified for tumor response, as assessed using the RECIST version 1.0 guideline, multiplied by 100. RECIST guidelines: CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions; PR was defined as at least a 30% decrease in sum of longest diameter of target lesions.
Measured: Randomization to measured disease progression up to 38 months
Overall Survival (OS)
OS is defined as the time from randomization to the date of death from any cause.
Measured: Baseline to date of death from any cause up to 45.5 months
Number of Participants With Adverse Events
A summary of serious and all other non-serious adverse events (AEs), which include AEs reported for pharmacological toxicity, is located in the Reported Adverse Event module.
Measured: Randomization up to 39 months
Percentage of Participants With CR, PR, and Stable Disease (SD) - Disease Control Rate (DCR)
DCR was defined as the percentage of participants with CR, PR, or SD divided by the number of randomized and treated participants as assessed using the RECIST criteria. CR was defined as the disappearance of all target lesions; PR was defined as 1) at least a 30% decrease in sum of longest diameter of target lesions or 2) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more non-target lesions; PD was defined as at least a 20% increase in sum of longest diameter of target lesions; SD was defined as small changes that did not meet the above criteria.
Measured: Randomization to disease progression up to 38 months
Time to Worsening of Symptoms (TWS) on Lung Cancer Symptoms Scale (LCSS)
TWS assessed using the LCSS a participant rated lung cancer instrument which consisted of 9 disease related symptoms and quality of life (QoL) items, with 6 subscales related to major lung cancer symptoms (appetite, cough, fatigue, dyspnea, hemoptysis, and pain) and 3 summation items related to QoL (activity status, symptomatic distress, and overall QoL). Each item is marked on a visual analog scale (VAS) 0 (low symptoms/QoL items) to 100 (high symptoms/QoL items). The mean of the 6 subscales is used to calculate the average symptom burden index. TWS was measured from the date of study enrollment to the first date of a worsening in any 1 of the 6 LCSS symptom-specific items (as defined by a VAS 15-mm increase from baseline in the patient-reported score for any of these 6 items).
Measured: Randomization to first date of worsening of any of 6 LCSS symptom specific items or up to 12.4 months
Number of Participants With Mutated or Non-Mutated Epidermal Growth Factor Receptor (EGFR) Genotype Status
EGFR mutation status was defined as: participants with any mutations detected were categorized as mutated and participants without any mutations detected were categorized as non-mutated.
Measured: Randomization to date of PD or death up to 38 months
Probability of OS at 12 Months
OS time is censored at the date of last contact for participants who were still alive or lost to follow-up.
Measured: Month 12

Timeline

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

Nov 2007Jan 2012

First posted29 Oct 2007 (estimated)
Study startNov 2007
Primary completionJan 2012
Study completionJan 2012

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.
Publications (1)Papers the sponsor has linked to this study.
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: 247 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00550173
Sponsor's protocol ID: 10725
Other IDs: H3E-MC-S103
Status last verified: Jan 2013
First submitted: 25 Oct 2007
Last updated: 13 Feb 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Lee DH, Lee JS, Kim SW, Rodrigues-Pereira J, Han B, Song XQ, Wang J, Kim HK, Sahoo TP, Digumarti R, Wang X, Altug S, Orlando M. Three-arm randomised controlled phase 2 study comparing pemetrexed and erlotinib to either pemetrexed or erlotinib alone as second-line treatment for never-smokers with non-squamous non-small cell lung cancer. Eur J Cancer. 2013 Oct;49(15):3111-21. doi: 10.1016/j.ejca.2013.06.035. Epub 2013 Jul 24.
PubMed 23890768

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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Study at a glance

From the registry record, last updated by the sponsor on 13 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Phase 2 Study Comparing Erlotinib-Pemetrexed, Pemetrexed Alone, and Erlotinib Alone, as Second-Line Treatment for Non-Smoker Patients With Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT00550173
Acronym / sponsor ID: 10725
Conditions: Non-Small-Cell Lung Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 247 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Nov 2007
Primary completion: Jan 2012 (actual)
Study completion: Jan 2012 (actual)
First posted: 29 Oct 2007 (estimated)
Results: Posted 13 Feb 2013

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: 3

Arm	Type	Receives
Pemetrexed + Erlotinib	Experimental	Drug: pemetrexed, Drug: erlotinibPemetrexed 500 milligrams per meter squared (mg/m^2) of body surface area, administered by intravenous (IV) infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
Erlotinib	Active comparator	Drug: erlotinibErlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
Pemetrexed	Active comparator	Drug: pemetrexedPemetrexed 500 mg/m^2 of body surface area, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.

Who may qualify

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

Key inclusion criteria (5 listed)

Patients with locally advanced or metastatic nonsquamous non-small cell lung cancer
Patients must be non-smokers
Patients must have at least one measurable lesion
Performance status of 0 to 2 on the Eastern Cooperative Oncology Group Scale
Patients must have failed only one prior chemotherapy regimen and must be considered eligible for further chemotherapy following progression of their disease.

Key exclusion criteria (5 listed)

Patients who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication
Patients who have previously received treatment with drugs against the human epidermal growth factor receptors
Patients who have previously received treatment with drugs which have similar targets as Pemetrexed
Patients who have any known significant ophthalmologic abnormalities of the surface of the eye
Patients who have a history of severe hypersensitivity reaction to erlotinib or pemetrexed

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 milligrams per meter squared (mg/m^2), intravenous (IV), every (q) 21 days until progression or unacceptable toxicity develops	Drug	Pemetrexed, Pemetrexed + Erlotinib
erlotinib150 mg, orally, once daily until progression or unacceptable toxicity develops	Drug	Erlotinib, Pemetrexed + Erlotinib

Primary outcome

Progression-Free Survival (PFS)
Time frame: Randomization to measured PD up to 38 months
PFS is defined as the time from randomization to the first date of progressive disease (PD; either objectively determined or clinical progression) or death from any cause. PD was defined as at least a 20% increase in sum of longest diameter of target lesions as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 guidelines. Time to disease progression was censored at the date of death.

7 secondary outcomes

Percentage of Participants With a Tumor Response of Complete Response (CR) or Partial Response (PR) [Tumor Response Rate (TRR)]
Time frame: Randomization to measured disease progression up to 38 months
Overall Survival (OS)
Time frame: Baseline to date of death from any cause up to 45.5 months
Number of Participants With Adverse Events
Time frame: Randomization up to 39 months
Percentage of Participants With CR, PR, and Stable Disease (SD) - Disease Control Rate (DCR)
Time frame: Randomization to disease progression up to 38 months
Time to Worsening of Symptoms (TWS) on Lung Cancer Symptoms Scale (LCSS)
Time frame: Randomization to first date of worsening of any of 6 LCSS symptom specific items or up to 12.4 months
Number of Participants With Mutated or Non-Mutated Epidermal Growth Factor Receptor (EGFR) Genotype Status
Time frame: Randomization to date of PD or death up to 38 months
Probability of OS at 12 Months
Time frame: Month 12

Results and safety

Results posted to the registry on 13 Feb 2013, 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 + Erlotinib	81	9
Erlotinib	82	19
Pemetrexed	84	11

Primary outcome: Progression-Free Survival (PFS)

Time frame: Randomization to measured PD up to 38 months. Median (95% Confidence Interval). Unit: months

Measure	Pemetrexed + Erlotinib n = 78	Erlotinib n = 82	Pemetrexed n = 80
Value	7.4 (4.4 to 12.9)	3.8 (2.7 to 6.3)	4.4 (3.0 to 6.0)

Pemetrexed + Erlotinib vs Erlotinib vs Pemetrexed: p = 0.003, Regression, Cox
Pemetrexed + Erlotinib vs Erlotinib: Hazard Ratio (HR): 0.57 (95% CI 0.40 to 0.81), p = 0.002, Regression, Cox
Pemetrexed + Erlotinib vs Pemetrexed: Hazard Ratio (HR): 0.58 (95% CI 0.39 to 0.85), p = 0.005, Regression, Cox

Population analysed: Qualified Intent to Treat (Q-ITT) Population defined as all participants with nonsquamous histology, who were randomized to therapy.

7 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 + Erlotinib	25 of 78 (32.1%)	72 of 78 (92.3%)	Not reported
Erlotinib	18 of 83 (21.7%)	76 of 83 (91.6%)	Not reported
Pemetrexed	22 of 80 (27.5%)	67 of 80 (83.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23890768Lee DH, Lee JS, Kim SW, Rodrigues-Pereira J, Han B, Song XQ, Wang J, Kim HK, Sahoo TP, Digumarti R, Wang X, Altug S, Orlando M. Three-arm randomised controlled phase 2 study comparing pemetrexed and erlotinib to either pemetrexed or erlotinib alone as second-line treatment for never-smokers with non-squamous non-small cell lung cancer. Eur J Cancer. 2013 Oct;49(15):3111-21. doi: 10.1016/j.ejca.2013.06.035. Epub 2013 Jul 24.
Lilly Clinical Trial RegistryLink provided by the sponsor.

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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

29 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pemetrexed and erlotinib in people with Non-Small-Cell Lung Cancer, run by Eli Lilly and Company at 29 sites in 7 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 13 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in India, United Kingdom, Brazil, China, South Korea and 2 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?

Yes. Results are posted in the registry (first posted 13 Feb 2013). 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: Randomization to measured PD up to 38 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 NCT00550173, which also lists 1 linked publication.

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 13 Feb 2013.