Histological or Cytological Diagnosis of Locally Advanced or Metastatic NSCLC of Nonsquamous Histology and Not Amenable to Curative Therapy.Phase 2NCT00447057

Study of Pemetrexed Versus Pemetrexed Plus Erlotinib as Treatment of Nonsquamous Non-Small Cell Lung Cancer (NSCLC)

A Phase 2 study testing Pemetrexed and Erlotinib in people with Histological or Cytological Diagnosis of Locally Advanced or Metastatic NSCLC of Nonsquamous Histology and Not Amenable to Curative Therapy., run by Eli Lilly and Company at 23 sites in 5 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

This is a multicenter, randomized, Phase 2, open label, parallel trial to evaluate an effect of pemetrexed alone on nonsquamous non-small cell lung cancer (NSCLC) in a second-line setting (such as progression-free survival [PFS], disease control rate, best response rate, time to treatment failure [TTTF], overall… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Histological or Cytological Diagnosis of Locally Advanced or Metastatic NSCLC of Nonsquamous Histology and Not Amenable to Curative Therapy.
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: 204 participants
Where: 23 sitesin 5 countries
Study dates: Mar 2007to Jun 2011
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

Histological or cytological diagnosis of locally advanced or metastatic NSCLC that is of nonsquamous histology and not amenable to curative therapy.
Failure of previous treatment with one prior platinum-based chemotherapy regimen.
Good performance status.
Adequate bone marrow reserve, renal and hepatic functions.

Who cannot join

Serious concomitant systemic disease.
Inability to take oral medication.
Inability or unwillingness to take vitamin supplementation and corticosteroids.
Pregnancy / Breast-feeding.
Treatment with certain medicines that prevent blood from clotting.

Trial locations and contacts

23 sites in 5 countries.

Country

City, postcode or hospital

23 sites in 5 countries

Germany10 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.
Bochum, 44791
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Freiburg im Breisgau, 79106
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Gauting, 82131
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Gerlingen, 70839
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Hamburg, D 21075
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Hanover, 30625
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Immenhausen, 34376
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Trier, 54219
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Tübingen, 72076
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Ulm, 89075

Other trials in Germany

Hungary4 sites

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Deszk, 6772
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Mátraháza, 3233
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Nyíregyháza, H-4400
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Székesfehérvár, 8000

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Spain4 sites

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Alicante, 03010
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Barcelona, 08036
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Madrid, 28050
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Valencia, 46010

Other trials in Spain

Sweden3 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.
Linköping, 58185
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Lund, 221 85
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Solna, 17176

Other trials in Sweden

Austria2 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.
Salzburg, 5020
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.
Vienna, A-1140

Other trials in Austria

About this study

Official title: A Phase 2 Study of Pemetrexed Versus Pemetrexed Plus Erlotinib in Second-Line Treatment in Patients With Nonsquamous NSCLC

Conditions: Histological or Cytological Diagnosis of Locally Advanced or Metastatic NSCLC of Nonsquamous Histology and Not Amenable to Curative Therapy.
Being tested: Pemetrexed, Erlotinib
Keywords: nonsquamous

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 mg/m² intravenous (iv) over 10 minutes on the first day of each 21-day cycle until disease progression (PD) or unacceptable toxicity
ErlotinibDrug
Also called Tarceva
150 mg given orally (po), daily (QD), starting on the first day of the first cycle
PemetrexedDrug
Also called LY231514, Alimta
500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity
ErlotinibDrug
Also called Tarceva
150 mg given po, QD, starting on the first day of the first cycle

Study groups in NCT00447057
Study group	Role	What they receive
Pemetrexed (Nonsquamous)	Experimental	Group of participants with non-small cell lung cancer (NSCLC) of nonsquamous histology who were assigned to Pemetrexed arm Receives: Drug: Pemetrexed
Pemetrexed + Erlotinib (Nonsquamous)	Experimental	Group of participants with NSCLC of nonsquamous histology who were assigned to Pemetrexed + Erlotinib arm Receives: Drug: Erlotinib; Drug: Pemetrexed
Pemetrexed (Squamous)	Experimental	Group of participants with NSCLC of squamous histology who were assigned to Pemetrexed arm Receives: Drug: Pemetrexed
Pemetrexed + Erlotinib (Squamous)	Experimental	Group of participants with NSCLC of squamous histology who were assigned to Pemetrexed + Erlotinib arm Receives: Drug: Pemetrexed; Drug: Erlotinib

What is being measured

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

Progression Free Survival (PFS)
PFS per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria using computed tomography (CT) or magnetic resonance imaging (MRI) for objective determination of progressive disease (PD: ≤20% increase in sum of longest diameter of target lesion). For participants alive as of data cut-off date who did not have PD, PFS was censored at date of last CT/MRI. For participants who received subsequent systemic anticancer therapy (after study discontinuation) prior to PD or death, PFS censored at date of last CT/MRI prior to initiation of post discontinuation systemic anticancer therapy.
Measured: Baseline to date of measured PD or death from any cause. Maximum follow-up was from baseline to 32.2 months

Secondary outcomes (6)

Percentage of Participants With Best Response of Stable Disease (SD), Partial Response (PR) or Complete Response (CR) (Disease Control Rate)
Per RECIST:
CR: Disappearance of all target lesions; PR: Either a) ≤30% decrease in sum of longest diameter (LD) of target lesions or b) complete disappearance of target lesions, with persistence (but not worsening) of ≥1 nontarget lesions. In either case, no new lesions may have appeared.
SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.
PD: ≤20% increase in sum of LD of target lesions. Disease Control Rate (%) = (SD+PR+CR)/number of participants in arm*100.
Measured: Baseline to measured PD. Maximum follow-up was from Baseline to 34 months
Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR) (Response Rate)
CR: Disappearance of all tumor lesions; PR: Either a) at least a 30% decrease in sum of LD of target lesions or b) complete disappearance of target lesions, with persistence (but not worsening) ≥1 nontarget lesions. In either case, no new lesions may have appeared.
SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.
PD: ≤20% increase in the sum of LD of target lesions. Response Rate (%) = (CR+PR)/number of participants in arm*100.
Measured: Baseline to measured progressive disease. Maximum follow-up was from Baseline to 34 months
Time to Treatment Failure (TTTF)
Defined as the time from randomization to death from any cause, first observation of PD, or study treatment discontinuation due to any reason other than "protocol complete" or "satisfactory response". For participants who discontinued due to "protocol complete" or "satisfactory response", or for participants not known to have discontinued as of the data cut-off date, TTTF was censored at the last contact date.
Measured: Baseline to first date among death from any cause, PD, or study treatment discontinuation for any reason other than "protocol complete" or "satisfactory response". Maximum follow-up was from Baseline to 32.2 months
Overall Survival (OS)
OS time is the duration from randomization to the date of death from any cause. For each participant who was not known to have died as of the data inclusion cut-off date, OS was censored at the date of last contact.
Measured: Baseline to date of death from any cause. Maximum follow-up was from Baseline to 42.6 months.
Percentage of Participants Surviving at 1 Year
Overall Survival (OS) rate at 1 year from the date of randomization was determined using the distribution of OS times and was estimated using the Kaplan-Meier method.
Measured: Baseline to date of death from any cause up to 1 year
Number of Participants With Adverse Events (AEs)
Summaries of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module.
Measured: Baseline up to 42.2 months

Timeline

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

Mar 2007Jun 2011

First posted13 Mar 2007 (estimated)
Study startMar 2007
Primary completionJul 2010
Study completionJun 2011

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 Histological or Cytological Diagnosis of Locally Advanced or Metastatic NSCLC of Nonsquamous Histology and Not Amenable to Curative Therapy.Studies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 204 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00447057
Sponsor's protocol ID: 10721
Other IDs: H3E-MC-S102
Status last verified: Sep 2011
First submitted: 9 Mar 2007
Last updated: 13 Oct 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Study of Pemetrexed Versus Pemetrexed Plus Erlotinib in Second-Line Treatment in Patients With Nonsquamous NSCLC
ClinicalTrials.gov ID: NCT00447057
Acronym / sponsor ID: 10721
Conditions: Histological or Cytological Diagnosis of Locally Advanced or Metastatic NSCLC of Nonsquamous Histology and Not Amenable to Curative Therapy.
Keywords: nonsquamous
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 204 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Mar 2007
Primary completion: Jul 2010 (actual)
Study completion: Jun 2011 (actual)
First posted: 13 Mar 2007 (estimated)
Results: Posted 13 Oct 2011

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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Pemetrexed (Nonsquamous)	Experimental	Drug: PemetrexedGroup of participants with non-small cell lung cancer (NSCLC) of nonsquamous histology who were assigned to Pemetrexed arm
Pemetrexed + Erlotinib (Nonsquamous)	Experimental	Drug: Erlotinib, Drug: PemetrexedGroup of participants with NSCLC of nonsquamous histology who were assigned to Pemetrexed + Erlotinib arm
Pemetrexed (Squamous)	Experimental	Drug: PemetrexedGroup of participants with NSCLC of squamous histology who were assigned to Pemetrexed arm
Pemetrexed + Erlotinib (Squamous)	Experimental	Drug: Pemetrexed, Drug: ErlotinibGroup of participants with NSCLC of squamous histology who were assigned to Pemetrexed + Erlotinib arm

Who may qualify

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

Key inclusion criteria (4 listed)

Histological or cytological diagnosis of locally advanced or metastatic NSCLC that is of nonsquamous histology and not amenable to curative therapy.
Failure of previous treatment with one prior platinum-based chemotherapy regimen.
Good performance status.
Adequate bone marrow reserve, renal and hepatic functions.

Key exclusion criteria (5 listed)

Serious concomitant systemic disease.
Inability to take oral medication.
Inability or unwillingness to take vitamin supplementation and corticosteroids.
Pregnancy / Breast-feeding.
Treatment with certain medicines that prevent blood from clotting.

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 mg/m² intravenous (iv) over 10 minutes on the first day of each 21-day cycle until disease progression (PD) or unacceptable toxicity	Drug	Pemetrexed (Nonsquamous)
ErlotinibAlso: Tarceva150 mg given orally (po), daily (QD), starting on the first day of the first cycle	Drug	Pemetrexed + Erlotinib (Nonsquamous)
PemetrexedAlso: LY231514, Alimta500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity	Drug	Pemetrexed (Squamous), Pemetrexed + Erlotinib (Nonsquamous), Pemetrexed + Erlotinib (Squamous)
ErlotinibAlso: Tarceva150 mg given po, QD, starting on the first day of the first cycle	Drug	Pemetrexed + Erlotinib (Squamous)

Primary outcome

Progression Free Survival (PFS)
Time frame: Baseline to date of measured PD or death from any cause. Maximum follow-up was from baseline to 32.2 months
PFS per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria using computed tomography (CT) or magnetic resonance imaging (MRI) for objective determination of progressive disease (PD: ≤20% increase in sum of longest diameter of target lesion). For participants alive as of data cut-off date who did not have PD, PFS was censored at date of last CT/MRI. For participants who received subsequent systemic anticancer therapy (after study discontinuation) prior to PD or death, PFS censored at date of last CT/MRI prior to initiation of post discontinuation systemic anticancer therapy.

6 secondary outcomes

Percentage of Participants With Best Response of Stable Disease (SD), Partial Response (PR) or Complete Response (CR) (Disease Control Rate)
Time frame: Baseline to measured PD. Maximum follow-up was from Baseline to 34 months
Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR) (Response Rate)
Time frame: Baseline to measured progressive disease. Maximum follow-up was from Baseline to 34 months
Time to Treatment Failure (TTTF)
Time frame: Baseline to first date among death from any cause, PD, or study treatment discontinuation for any reason other than "protocol complete" or "satisfactory response". Maximum follow-up was from Baseline to 32.2 months
Overall Survival (OS)
Time frame: Baseline to date of death from any cause. Maximum follow-up was from Baseline to 42.6 months.
Percentage of Participants Surviving at 1 Year
Time frame: Baseline to date of death from any cause up to 1 year
Number of Participants With Adverse Events (AEs)
Time frame: Baseline up to 42.2 months

Results and safety

Results posted to the registry on 13 Oct 2011, 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 (Nonsquamous)	83	0
Pemetrexed + Erlotinib (Nonsquamous)	76	3
Pemetrexed (Squamous)	19	0
Pemetrexed + Erlotinib (Squamous)	26	0

Primary outcome: Progression Free Survival (PFS)

Time frame: Baseline to date of measured PD or death from any cause. Maximum follow-up was from baseline to 32.2 months. Median (95% Confidence Interval). Unit: months

Measure	Pemetrexed (Nonsquamous) n = 70	Pemetrexed + Erlotinib (Nonsquamous) n = 60
Value	2.9 (1.94 to 3.38)	3.2 (2.86 to 4.70)

Pemetrexed (Nonsquamous) vs Pemetrexed + Erlotinib (Nonsquamous): Hazard Ratio (HR): 0.63 (95% CI 0.438 to 0.897), p = 0.0047, Log Rank

Population analysed: Includes Nonsquamous population only. In Pemetrexed arm, 13 (15.7%) participants censored overall: 12 (14.5%) because of receiving subsequent systemic anticancer therapy. In Pemetrexed + Erlotinib arm, 16 (21.1%) participants censored overall: 9 (11.8%) because of receiving subsequent systemic anticancer therapy.

6 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 (Nonsquamous and Squamous)	43 of 102 (42.2%)	91 of 102 (89.2%)	Not reported
Pemetrexed + Erlotinib (Nonsquamous and Squamous)	53 of 102 (52%)	98 of 102 (96.1%)	Not reported

Limitations and caveats (from the sponsor): Baseline Characteristics are presented by histology (nonsquamous/squamous) for each arm. Per the protocol amendment of August 2008, study entry criteria were changed to exclude participants with predominantly squamous cell histology.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Lilly Clinical Trial RegistryLink provided by the sponsor.

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

23 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 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 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Germany, Hungary, Spain, Sweden, Austria. 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 Oct 2011). 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 date of measured PD or death from any cause. Maximum follow-up was from baseline to 32.2 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 NCT00447057.

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 Oct 2011.