Non-small Cell Lung CancerPhase 2NCT00409006
Chemotherapy for Patients With Non-Small Cell Lung Cancer Who Are Non-Smokers
A Phase 2 study testing Pemetrexed, Cisplatin and Gefitinib in people with Non-small Cell Lung Cancer, run by Eli Lilly and Company at 7 sites in 3 countries.
Trial summary
The purpose of this study is to compare the efficacy and safety of chemotherapy followed sequentially by gefitinib versus chemotherapy alone in the first line treatment of 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?
- Pemetrexed, Cisplatin and Gefitinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Feb 2007to May 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
- Histologic or cytologic diagnosis non-small cell lung cancer (NSCLC) (Stage IIIB or IV)
- Have not received any prior chemotherapy, molecular therapy, immunotherapy, biological therapy, or radiotherapy. Exception: palliative radiotherapy that is completed at least 4 weeks prior to study enrolment.
- Have 'never smoked' (defined as having smoked <100 cigarettes during his/her lifetime)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
Who cannot join
- Concurrent administration of any other tumor therapy
- Other co-existing malignancies
- Pregnancy or breast feeding
- Serious concomitant disorders
- Inability or unwillingness to take folic acid or vitamin B12 supplementation
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
China3 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.
Fujian, 350014
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.
Qingdao, 266003
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.
Shanghai, 201900
Taiwan3 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.
Changhua, 500
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.
Taipei, 100
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.
Taoyuan, 333
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, 137-701
About this study
Official title: A Phase 2 Trial of Pemetrexed and Cisplatin Followed Sequentially by Gefitinib Versus Pemetrexed and Cisplatin in Asian "Never Smoker" Patients With Advanced Non-Small Cell Lung Cancer
The purpose of this study is to compare the efficacy and safety of chemotherapy followed sequentially by gefitinib versus chemotherapy alone in the first line treatment of non-small cell lung cancer (NSCLC). This study will be conducted in Asian patients who are classified as 'never smoker' since it is suggested that these patients are more likely to respond favorably to treatment with gefitinib.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Pemetrexed, Cisplatin, Gefitinib
- 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/m2), administered by intravenous (IV) infusion every 21 days for 4 cycles (1-4) or 500 mg/m2, IV, every 21 days until disease progression or unacceptable toxicity.
CisplatinDrug
75 mg/m2, IV, every 21 days for 4 cycles (1-4) or 75 mg/m2, IV, every 21 days for 4 cycles with optional continuation for 2 additional cycles until disease progression or unacceptable toxicity
GefitinibDrug
250 mg, administered orally once daily beginning at Cycle 5 until disease progression or unacceptable toxicity
| Study group | Role | What they receive |
|---|---|---|
| Pemetrexed/Cisplatin/Gefitinib | Experimental | Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity. Receives: Drug: Pemetrexed; Drug: Cisplatin; Drug: Gefitinib |
| Pemetrexed/Cisplatin | Experimental | Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity. Receives: Drug: Pemetrexed; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Defined as the time from randomization to the first observation of disease progression, or death due to any cause.
Measured: Baseline to first observation of disease progression or death, 12 weeks up to 31 months
Secondary outcomes (3)
Number of Participants With Tumor Response
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes not meeting above criteria. Responder is a participant exhibiting a best overall study response of CR or PR.
Measured: Baseline to measured response or death, 12 weeks up to 31 months
Duration of Response for Responders
The duration of a complete response (CR; the disappearance of all target lesions) or partial response (PR; at least a 30% decrease in the sum of the longest diameter of target lesions) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. A responder is a patient exhibiting a best overall study response of CR or PR.
Measured: Time of response to progressive disease or death, 12 weeks up to 31 months
Overall Survival
Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact. Median overall survival could not be estimated as most participants were living at the end of the study. 25 participants from each treatment group were censored. In place of this outcome measure, the percentage of participants who died during the study are provided in the Post-Hoc Analysis Outcome Measure: Percentage of Participants Who Died During the Study.
Measured: Baseline to date of death from any cause, 12 weeks up to 31 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2006 (estimated)
- Study startFeb 2007
- Primary completionAug 2009
- Study completionMay 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00409006
- Sponsor's protocol ID
- 10918
- Other IDs
- H3E-AA-S110
- Status last verified
- Aug 2010
- First submitted
- 6 Dec 2006
- Last updated
- 9 Sep 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ahn MJ, Yang JC, Liang J, Kang JH, Xiu Q, Chen YM, Blair JM, Peng G, Linn C, Orlando M. Randomized phase II trial of first-line treatment with pemetrexed-cisplatin, followed sequentially by gefitinib or pemetrexed, in East Asian, never-smoker patients with advanced non-small cell lung cancer. Lung Cancer. 2012 Aug;77(2):346-52. doi: 10.1016/j.lungcan.2012.03.011. Epub 2012 Apr 23.
PubMed 22534669
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Trial of Pemetrexed and Cisplatin Followed Sequentially by Gefitinib Versus Pemetrexed and Cisplatin in Asian "Never Smoker" Patients With Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00409006
- Acronym / sponsor ID
- 10918
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 8 Dec 2006 (estimated)
- Results
- Posted 9 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the efficacy and safety of chemotherapy followed sequentially by gefitinib versus chemotherapy alone in the first line treatment of non-small cell lung cancer (NSCLC). This study will be conducted in Asian patients who are classified as 'never smoker' since it is suggested that these patients are more likely to respond favorably to treatment with gefitinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pemetrexed/Cisplatin/Gefitinib | Experimental | Drug: Pemetrexed, Drug: Cisplatin, Drug: GefitinibPemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity. |
| Pemetrexed/Cisplatin | Experimental | Drug: Pemetrexed, Drug: CisplatinPemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologic or cytologic diagnosis non-small cell lung cancer (NSCLC) (Stage IIIB or IV)
- Have not received any prior chemotherapy, molecular therapy, immunotherapy, biological therapy, or radiotherapy. Exception: palliative radiotherapy that is completed at least 4 weeks prior to study enrolment.
- Have 'never smoked' (defined as having smoked <100 cigarettes during his/her lifetime)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
Key exclusion criteria (5 listed)
- Concurrent administration of any other tumor therapy
- Other co-existing malignancies
- Pregnancy or breast feeding
- Serious concomitant disorders
- Inability or unwillingness to take folic acid or vitamin B12 supplementation
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/m2), administered by intravenous (IV) infusion every 21 days for 4 cycles (1-4) or 500 mg/m2, IV, every 21 days until disease progression or unacceptable toxicity. | Drug | Pemetrexed/Cisplatin, Pemetrexed/Cisplatin/Gefitinib |
| Cisplatin75 mg/m2, IV, every 21 days for 4 cycles (1-4) or 75 mg/m2, IV, every 21 days for 4 cycles with optional continuation for 2 additional cycles until disease progression or unacceptable toxicity | Drug | Pemetrexed/Cisplatin, Pemetrexed/Cisplatin/Gefitinib |
| Gefitinib250 mg, administered orally once daily beginning at Cycle 5 until disease progression or unacceptable toxicity | Drug | Pemetrexed/Cisplatin/Gefitinib |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Baseline to first observation of disease progression or death, 12 weeks up to 31 months
Defined as the time from randomization to the first observation of disease progression, or death due to any cause.
3 secondary outcomes
Number of Participants With Tumor Response
Time frame: Baseline to measured response or death, 12 weeks up to 31 months
Duration of Response for Responders
Time frame: Time of response to progressive disease or death, 12 weeks up to 31 months
Overall Survival
Time frame: Baseline to date of death from any cause, 12 weeks up to 31 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22534669Ahn MJ, Yang JC, Liang J, Kang JH, Xiu Q, Chen YM, Blair JM, Peng G, Linn C, Orlando M. Randomized phase II trial of first-line treatment with pemetrexed-cisplatin, followed sequentially by gefitinib or pemetrexed, in East Asian, never-smoker patients with advanced non-small cell lung cancer. Lung Cancer. 2012 Aug;77(2):346-52. doi: 10.1016/j.lungcan.2012.03.011. Epub 2012 Apr 23.
- 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
7 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, Cisplatin and Gefitinib in people with Non-small Cell Lung Cancer, run by Eli Lilly and Company at 7 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 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 9 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China, Taiwan, South Korea. 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 9 Sep 2010). 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 first observation of disease progression or death, 12 weeks up to 31 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 NCT00409006, 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 9 Sep 2010.