Non Small Cell Lung CancerPhase 2NCT00606021
A Study Comparing of Two Different Chemotherapy Regimens, in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
A Phase 2 study testing pemetrexed in people with Non Small Cell Lung Cancer, run by Eli Lilly and Company at 5 sites in 3 countries.
Trial summary
This is a multicenter, open-label, randomized, two-arm Phase 2 study comparing pemetrexed plus best supportive care with best supportive care alone as maintenance therapy following first-line treatment with a pemetrexed-cisplatin combination in patients with advanced non-squamous non-small cell lung cancer. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Jan 2008to Dec 2010
- 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
- You must be at least 18 years old
- You must have been diagnosed with non-squamous non-small cell lung cancer (NSCLC)
- You must have had no prior systemic anticancer therapy for lung cancer
- You must live close enough to the study doctor to be able to visit regularly for follow up
- You must have signed informed consent form indicating your willingness to take part in this study
- Your laboratory and medical history and tests must meet study requirements
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
- Prior radiotherapy and surgery should be completed at least 4 weeks prior to initiation of treatment
- Serious concomitant systemic disorder (e.g., active infection including human immunodeficiency virus, or unstable cardiovascular disease)
- Prior malignancy other than NSCLC, carcinoma in situ of the cervix, or nonmelanoma skin cancer unless treated at least 5 years previously with no subsequent evidence of recurrence
- Brain metastasis
- Presence of clinically significant (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry
Show all 12Show fewer
- Significant weight loss (greater than 10%), over the previous 6 weeks before study entry
- Concurrent administration of any other antitumor therapy
- Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents such as piroxicam)
- Inability or unwillingness to take folic acid, dexamethasone (or equivalent) or vitamin B12 supplementation
- Pregnancy or breast-feeding
- You are allergic to pemetrexed
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Egypt3 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.
Asyut, 0000
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.
Cairo, 11372
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.
Mounofia, 32514
Lebanon1 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.
Beirut
Saudi Arabia1 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.
Riyadh, 11211
About this study
Official title: A Randomized Phase 2 Study Comparing Pemetrexed Plus Best Supportive Care With Best Supportive Care as Maintenance, Following First-Line Treatment With Pemetrexed-Cisplatin, in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
This is a multicenter, open-label, randomized, two-arm Phase 2 study comparing pemetrexed plus best supportive care with best supportive care alone as maintenance therapy following first-line treatment with a pemetrexed-cisplatin combination in patients with advanced non-squamous non-small cell lung cancer.
A total of approximately 100 patients are planned to be enrolled, and following completion of four cycles of pemetrexed-cisplatin (Induction Phase) those patients in which disease progression has not occurred will be randomized in a 2:1 ratio to one of two treatment arms (Maintenance Phase): Arm A (pemetrexed plus best supportive care) or Arm B (best supportive care alone).
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- pemetrexed, Best Supportive Care
- 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 Alimta, LY231514
500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles
Best Supportive CareDrug
Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
| Study group | Role | What they receive |
|---|---|---|
| A: Pemetrexed + Best Supportive Care | Experimental | Pemetrexed: 500 milligrams per square meter (mg/m²) , intravenous (IV), Day 1 of each 21-day cycle for 6 cycles
Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician. Receives: Drug: pemetrexed; Drug: Best Supportive Care |
| B: Best Supportive Care | Active comparator | Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician. Receives: Drug: Best Supportive Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival During Maintenance Phase
Progression free survival is defined as the time from randomization until the date of progression of disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is ≥20% increase in sum of longest diameter of target lesions. PD in maintenance phase uses the last lesion assessment prior to randomization as the baseline assessment.
Measured: Randomization to progression of disease (PD) or date of death from any cause up to 30.9 months
Secondary outcomes (5)
Progression Free Survival During Overall Period (Induction Phase [IP] + Maintenance Phase [MP])
Progression-free survival in overall period is defined as the time from the date of first dose of study drug during IP until the date of PD or death from any cause. PD was determined using RECIST criteria. PD is ≥20% increase in sum of longest diameter of target lesions. PD in overall period uses the screening lesion assessment prior to the induction phase as the baseline assessment.
Measured: First dose of study drug during IP to PD or date of death from any cause up to 33.6 months
Overall Survival During Maintenance Phase
Overall survival in maintenance phase is defined as the time from randomization to death. Participants who were alive were censored at the last contact.
Measured: Randomization to PD or date of death from any cause up to 31.3 months
Overall Survival During Overall Period (IP + MP)
Overall survival in overall period is defined as the time from first dose of study drug during IP to death. Participants who were alive were censored at the last contact.
Measured: First dose of study drug during IP to PD or date of death from any cause up to 34.1 months
Number of Participants With Adverse Events (AEs) During Overall Period
The list of serious adverse events (SAEs) and other non-serious adverse events (AEs) are in Adverse Events Section.
Measured: First dose of study drug during IP through overall study completion (up to 34.3) months
Tumor Response Rate and Disease Control Rate After Induction Phase (IP)
Tumor response rate (%) is the number of responders (participants with best response of CR or PR) divided by the number of participants qualified for tumor response according to RECIST criteria multiplied by 100. Disease control rate is percentage of participants with a best response of stable disease [SD], PR, or CR. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; PD is≥20% increase in sum of longest diameter of target lesions. SD= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Measured: Randomization to measured PD up to 31.4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2010
- Study completionDec 2010
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
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9am to 5pm Eastern Time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00606021
- Sponsor's protocol ID
- 11839
- Other IDs
- H3E-EZ-S114
- Status last verified
- Nov 2011
- First submitted
- 17 Jan 2008
- Last updated
- 26 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Mubarak N, Gaafar R, Shehata S, Hashem T, Abigeres D, Azim HA, El-Husseiny G, Al-Husaini H, Liu Z. A randomized, phase 2 study comparing pemetrexed plus best supportive care versus best supportive care as maintenance therapy after first-line treatment with pemetrexed and cisplatin for advanced, non-squamous, non-small cell lung cancer. BMC Cancer. 2012 Sep 24;12:423. doi: 10.1186/1471-2407-12-423.
PubMed 23006447
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2 Study Comparing Pemetrexed Plus Best Supportive Care With Best Supportive Care as Maintenance, Following First-Line Treatment With Pemetrexed-Cisplatin, in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00606021
- Acronym / sponsor ID
- 11839
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 1 Feb 2008 (estimated)
- Results
- Posted 26 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, open-label, randomized, two-arm Phase 2 study comparing pemetrexed plus best supportive care with best supportive care alone as maintenance therapy following first-line treatment with a pemetrexed-cisplatin combination in patients with advanced non-squamous non-small cell lung cancer.
A total of approximately 100 patients are planned to be enrolled, and following completion of four cycles of pemetrexed-cisplatin (Induction Phase) those patients in which disease progression has not occurred will be randomized in a 2:1 ratio to one of two treatment arms (Maintenance Phase): Arm A (pemetrexed plus best supportive care) or Arm B (best supportive care alone).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Pemetrexed + Best Supportive Care | Experimental | Drug: pemetrexed, Drug: Best Supportive CarePemetrexed: 500 milligrams per square meter (mg/m²) , intravenous (IV), Day 1 of each 21-day cycle for 6 cycles Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician. |
| B: Best Supportive Care | Active comparator | Drug: Best Supportive CareBest Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- You must be at least 18 years old
- You must have been diagnosed with non-squamous non-small cell lung cancer (NSCLC)
- You must have had no prior systemic anticancer therapy for lung cancer
- You must live close enough to the study doctor to be able to visit regularly for follow up
- You must have signed informed consent form indicating your willingness to take part in this study
Key exclusion criteria (12 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
- Prior radiotherapy and surgery should be completed at least 4 weeks prior to initiation of treatment
- Serious concomitant systemic disorder (e.g., active infection including human immunodeficiency virus, or unstable cardiovascular disease)
- Prior malignancy other than NSCLC, carcinoma in situ of the cervix, or nonmelanoma skin cancer unless treated at least 5 years previously with no subsequent evidence of recurrence
- Brain metastasis
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: Alimta, LY231514500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles | Drug | A: Pemetrexed + Best Supportive Care |
| Best Supportive CarePatients will receive best supportive care (dose, frequency, duration) as judged by their treating physician. | Drug | A: Pemetrexed + Best Supportive Care, B: Best Supportive Care |
Primary outcome
Progression Free Survival During Maintenance Phase
Time frame: Randomization to progression of disease (PD) or date of death from any cause up to 30.9 months
Progression free survival is defined as the time from randomization until the date of progression of disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is ≥20% increase in sum of longest diameter of target lesions. PD in maintenance phase uses the last lesion assessment prior to randomization as the baseline assessment.
5 secondary outcomes
Progression Free Survival During Overall Period (Induction Phase [IP] + Maintenance Phase [MP])
Time frame: First dose of study drug during IP to PD or date of death from any cause up to 33.6 months
Overall Survival During Maintenance Phase
Time frame: Randomization to PD or date of death from any cause up to 31.3 months
Overall Survival During Overall Period (IP + MP)
Time frame: First dose of study drug during IP to PD or date of death from any cause up to 34.1 months
Number of Participants With Adverse Events (AEs) During Overall Period
Time frame: First dose of study drug during IP through overall study completion (up to 34.3) months
Tumor Response Rate and Disease Control Rate After Induction Phase (IP)
Time frame: Randomization to measured PD up to 31.4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23006447Mubarak N, Gaafar R, Shehata S, Hashem T, Abigeres D, Azim HA, El-Husseiny G, Al-Husaini H, Liu Z. A randomized, phase 2 study comparing pemetrexed plus best supportive care versus best supportive care as maintenance therapy after first-line treatment with pemetrexed and cisplatin for advanced, non-squamous, non-small cell lung cancer. BMC Cancer. 2012 Sep 24;12:423. doi: 10.1186/1471-2407-12-423.
- 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 9am to 5pm Eastern Time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pemetrexed in people with Non Small Cell Lung Cancer, run by Eli Lilly and Company at 5 sites in 3 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 6 inclusion and 12 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 26 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Egypt, Lebanon, Saudi Arabia. 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 26 Dec 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 During Maintenance Phase (time frame: Randomization to progression of disease (PD) or date of death from any cause up to 30.9 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 NCT00606021, 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 26 Dec 2011.