Non Small Cell Lung CancerPhase 3NCT00440414
Trial of Pemetrexed Versus Erlotinib in Pretreated Patients With Non Small Cell Lung Cancer (NSCLC)
A Phase 3 study testing Erlotinib (Tarceva) and Pemetrexed (Alimta) in people with Non Small Cell Lung Cancer, run by Hellenic Oncology Research Group at 9 sites in Greece.
Trial summary
The second-line treatment in advanced NSCLC has been currently proved effective in prolonging overall survival and improving quality of life. Both pemetrexed and erlotinib have been approved for second-line treatment of NSCLC . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Erlotinib (Tarceva) and Pemetrexed (Alimta)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 9 sitesGreece
- Study dates
- Apr 2006to Apr 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically- or cytologically- confirmed Non-Small-Cell Lung Cancer adenocarcinoma
- Stage IIIB/IV
- Failure to prior chemotherapy
- Presence of two-dimensional measurable disease. The measurable disease should not have been irradiated
- Absence or irradiated and stable central nervous system metastatic disease.
- Life expectancy of more than 3 months
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- Tissue sample desired for genomic study
- Age ≥ 18 years
- Performance status (WHO) < 3
- For patients > 65 years old: "non-frail" according to comprehensive geriatric assessment
- Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9gr/mm^3)
- Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2mg/dl)
- Presence of a reliable care giver for patients > 65 years old
- Informed consent.
Who cannot join
- Psychiatric illness or social situation that would preclude study compliance
- Other concurrent uncontrolled illness
- Other invasive malignancy within the past 5 years except nonmelanoma skin cancer
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Greece9 sites
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli
401 Military Hospital, Medical Oncology Unit
Athens
Air Forces Military Hospital, Dep of Medical Oncology
Athens
IASO General Hospital of Athens, 1st Department of Medical Oncology
Athens
Laikon General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens
Sismanogleio General Hospital, 1st, 2nd Department of Pulmonary Diseases
Athens
Sotiria General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases
Athens
Metaxa's Anticancer Hospital of Piraeus,1st Dep of Medical Oncology
Piraeus
Theagenion Anticancer Hospital of Thessaloniki
Thessaloniki
About this study
Official title: A Multicenter Randomized Phase III Study of Pemetrexed Versus Erlotinib in Patients With Pretreated Advanced Non-Small-Cell Lung Cancer (NSCLC)
The second-line treatment in advanced NSCLC has been currently proved effective in prolonging overall survival and improving quality of life. Both pemetrexed and erlotinib have been approved for second-line treatment of NSCLC . Erlotinib is a valuable option for the treatment of advanced NSCLC, especially for elderly patients, due to convenience of administration and safety profile. The role of comprehensive geriatric assessment in treatment efficacy and tolerance is an area of investigation.
Read the detailed description
This trial will compare the efficacy of pemetrexed versus erlotinib in pretreated patients with advanced NSCLC.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Erlotinib (Tarceva), Pemetrexed (Alimta)
- Keywords
- Cancer, Non-small-cell lung cancer, Chemotherapy, Pemetrexed, Erlotinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erlotinib (Tarceva)Drug
Also called Tarceva
Erlotinib at the dose of 150 mg orally once a day continually until progression
Pemetrexed (Alimta)Drug
Also called Alimta
Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks for 6 consecutive cycles
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Alimta Receives: Drug: Pemetrexed (Alimta) |
| 2 | Experimental | Tarceva Receives: Drug: Erlotinib (Tarceva) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Tumor Progression
Measured: 1 year TTP
Secondary outcomes (4)
Overall response rate
Measured: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Overall survival between the two treatment arms
Measured: 1 year OS
Quality of life assessment
Measured: Assessment every two cycles
Toxicity profile between the two treatment arms
Measured: Toxicity assessment on each chemotherapy cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2007 (estimated)
- Study startApr 2006
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hellenic Oncology Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Crete
- Investigators
- Lampros Vamvakas, MD, Principal investigator, University Hospital of CreteAthanasios Karampeazis, MD, Principal investigator, University Hospital of Crete
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00440414
- Sponsor's protocol ID
- CT/06.05
- Status last verified
- Aug 2010
- First submitted
- 26 Feb 2007
- Last updated
- 19 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Phase III Study of Pemetrexed Versus Erlotinib in Patients With Pretreated Advanced Non-Small-Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT00440414
- Acronym / sponsor ID
- CT/06.05
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Cancer, Non-small-cell lung cancer, Chemotherapy, Pemetrexed, Erlotinib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Hellenic Oncology Research GroupUniversity, hospital or other
- Collaborators
- University Hospital of Crete
- Study start
- Apr 2006
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 27 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The second-line treatment in advanced NSCLC has been currently proved effective in prolonging overall survival and improving quality of life. Both pemetrexed and erlotinib have been approved for second-line treatment of NSCLC . Erlotinib is a valuable option for the treatment of advanced NSCLC, especially for elderly patients, due to convenience of administration and safety profile. The role of comprehensive geriatric assessment in treatment efficacy and tolerance is an area of investigation.
Detailed description
This trial will compare the efficacy of pemetrexed versus erlotinib in pretreated patients with advanced NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Pemetrexed (Alimta)Alimta |
| 2 | Experimental | Drug: Erlotinib (Tarceva)Tarceva |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically- or cytologically- confirmed Non-Small-Cell Lung Cancer adenocarcinoma
- Stage IIIB/IV
- Failure to prior chemotherapy
- Presence of two-dimensional measurable disease. The measurable disease should not have been irradiated
- Absence or irradiated and stable central nervous system metastatic disease.
Key exclusion criteria (3 listed)
- Psychiatric illness or social situation that would preclude study compliance
- Other concurrent uncontrolled illness
- Other invasive malignancy within the past 5 years except nonmelanoma skin cancer
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 |
|---|---|---|
| Erlotinib (Tarceva)Also: TarcevaErlotinib at the dose of 150 mg orally once a day continually until progression | Drug | 2 |
| Pemetrexed (Alimta)Also: AlimtaPemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks for 6 consecutive cycles | Drug | 1 |
Primary outcome
Time to Tumor Progression
Time frame: 1 year TTP
4 secondary outcomes
Overall response rate
Time frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Overall survival between the two treatment arms
Time frame: 1 year OS
Quality of life assessment
Time frame: Assessment every two cycles
Toxicity profile between the two treatment arms
Time frame: Toxicity assessment on each chemotherapy cycles
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2010.
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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.
Lampros Vamvakas, MD principal investigator
University Hospital of Crete
Athanasios Karampeazis, MD principal investigator
University Hospital of Crete
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Erlotinib (Tarceva) and Pemetrexed (Alimta) in people with Non Small Cell Lung Cancer, run by Hellenic Oncology Research Group at 9 sites in Greece.
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 14 inclusion and 3 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 19 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Greece. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to Tumor Progression (time frame: 1 year TTP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2010; AzTrials last refreshed its copy on 8 Nov 2026.